Coalition comments to the FDA on voluntary sodium reduction goals

October 17, 2016

 

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

 

 

Comments of members of the Patient, Consumer, and Public Health Coalition on Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations or Sodium in Commercially Processed, Packaged, and Prepared Foods

[Docket No. FDA-2014-D-0055]

 

 

As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Food and Drug Administration’s voluntary sodium reduction goals.  We agree that high sodium consumption “is a contributory factor in the development of hypertension, which is a leading cause of heart disease and stroke.”[1]

 

We support FDA’s approach to lowering sodium content by avoiding “large, abrupt changes to individual products that might result in noticeably altered taste, greatly reduced shelf life, or other undesirable product outcomes.”[2]

 

We also support FDA’s “plan to monitor the levels of other nutrients (e.g., added sugars and saturated fat) … to ensure that no broad trends emerge that negatively affect the nutritional quality of the foods.” [3] This has happened in the past when processed food manufacturers lowered the fat content of products such as cereals, yogurts, and snacks but then spiked the sugar levels to improve taste.[4]

 

The overall goal of this guidance is to reduce sodium intake in the general population to 2,300 mg/day from the current average adult level of 3,400 mg/day.[5] More than three-quarters of sodium that Americans consume is added when the food is manufactured or commercially prepared. By encouraging manufactures, retailers and food service to reduce sodium, consumers have more access to healthier choices.

 

Research provides important information that should be used to help determine how best to reduce salt intake. A recent study by the U.S. Department of Agriculture found wide variation in the amount of sodium in similar types of products, which suggests that current food manufacturing practices and food preferences vary enough that sodium levels could be reduced in some types of foods relatively easily, and without reducing consumers’ enthusiasm for those products.[6] Others have examined the amount of sodium in the same or similar items from the same fast food restaurants in different countries or in the US over time. Again there were wide variations in the amount of sodium, suggesting that gradual changes in salt levels would not have a negative impact on consumer preferences.[7] [8]

 

We support the FDA’s approach of using mg/ 100g as a standard way to monitor changes in the sodium in various foods independent of changes in serving size or other nutrient levels. However, it would be helpful for consumers and health professionals to also see what these changes mean in units that are found in the marketplace. This would increase transparency and allow outside monitoring.

 

We also want to encourage caution with the development of new or expanded use of food additives and other substances for food preservation or salty flavor. Any such chemicals or substances should be sufficiently studied to ensure that they do not have a negative impact on health in the short-term or long-term.

 

By making healthier options more available, consumers are able to choose foods based on what is important to them. We believe that many consumers will choose healthier options when they become available and as lower sodium levels become the norm. Current initiatives by individual companies, New York City, and the United Kingdom have shown that large reductions in sodium content are attainable and attractive to consumers.

 

We reject the claim that some target levels for sodium might be low enough to be unhealthy. “More than 75 percent of the sodium in the average American Diet comes from salt added to processed foods,” according to the American Heart Association.[9] Consumers can continue to add salt to their food, if they choose to do so, since  able salt is plentiful and inexpensive in the United States. Currently, it is difficult for individuals to lower the sodium in their diet because the salt is added before the consumer purchases it. Reducing the sodium in processed and restaurant foods gives individuals greater control over the amount of sodium that they consume.

 

In summary, we strongly support the FDA’s effort to reduce sodium levels in foods, while monitoring foods to ensure that sodium reductions are not offset by unhealthy changes in nutrients such as increased saturated fat or sugar. The FDA must also ensure that methods to compensate for the reduction do not include substances that could harm consumers. Reducing sodium levels in processed and prepared food would provide consumers with more control over the amount of sodium they consume and thus make it easier for individuals to choose a lower sodium diet and lower the risk for hypertension, heart disease, and stroke.

American Medical Student Association

American Medical Women’s Association

Jacobs Institute of Women’s Health

MRSA Survivors Network

National Center for Health Research

National Physicians Alliance

Washington Advocates for Patient Safety

WomenHeart: The National Coalition for Women with Heart Disease

WoodyMatters

 

[1] FDA DG (June 2016).

[2] Food and Drug Administration (June 2016). Draft guidance, Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations or Sodium in Commercially Processed, Packaged, and Prepared Foods [Docket NO. FDA-2014-D-0055].

[3] FDA DG (June 2016).

[4] Nguyen PK et al  (2016) A systematic comparison of sugar content in low-fat vs regular versions of food. Nutrition & Diabetes 6:e193.

[5] FDA DG (June 2016).

[6] Ahuja, JKC et al (2015) Sodium content of popular commercially processed and restaurant foods in the United States. Preventive Medicine Reports 2:962-967.

[7] Dunford E et al (2012) The variability of reported salt levels in fast foods across six countries: opportunities for salt reduction. CMAJ 184(9):1023-1028.

[8] Rudelt A et al (2012) Fourteen-year trends in sodium content of menu offerings at eight leading fast food restaurants in the USA. Public Health Nutrition 17(8):1682-1688.

[9] American Heart Association (December 8, 2015). Processed Foods: Where is all that salt coming from?

FDA should require device makers to include more diverse populations in their analysis of clinical trials

September 19, 2016

 

Comments of Patient, Consumer, and Public Health Coalition

 on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff”

Docket No. FDA-2016-D-0734

 

Members of the Patient, Consumer, and Public Health Coalition have substantial concerns about the weaknesses of the draft guidance “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.”  It does not go far enough to improve the proportion of medical devices that are as safe and effective as possible for all subgroups included in an indication for approval.

The purpose of the guidance is to outline FDA’s expectations for the evaluation and “reporting of age, race and ethnicity [subgroups] data in medical device clinical studies.”  FDA evaluated the subgroup “sex” in a previous guidance.[1] 

We agree with the guidance’s recommendation that “clinical trials include diverse populations that reflect the intended populations,” but strongly disagree with the caveat “especially when clinically meaningful differences in safety, effectiveness…or benefit-risk profile are expected across these groups.”   We oppose that caveat because in many cases when the risk-benefit ratio differs, those differences were not expected.

We agree that sponsors (device makers) “should develop a strategy to enroll diverse populations.”  We also agree that these data are needed because “historically many medical device clinical studies” have not included subgroups in proportions that reflect “disease distribution in the affected [subgroup] population.”[2]  In fact, members of our coalition have worked on this issue for many years. For example, at a 2014 FDA AC meeting for a weight-loss device, National Center for Health Research (NCHR) noted that even though four out of five Black women in the U.S. are overweight or obese and Hispanic women are more likely to be overweight compared to White women as well, the clinical trial was 93% White. Only 11 patients were Black and only 2 were Hispanic.  Although the Advisory Committee members voiced their concerns about the mostly white sample, they voted for approval of this device anyway.  This shows two problems: 1) the FDA is not requiring diversity in clinical trials and 2) when companies fail to include sufficient numbers of minority groups to conduct subgroup analyses, the FDA is not providing instructions to their Advisory Committee members that such diversity is essential for FDA approval and for public health.

Several of our members also spoke at the April 2014 Section 907 hearing on this issue.  We noted the importance of including women, minorities and the elderly in clinical studies of safety and effectiveness for drugs and devices. We recommended that subgroup analyses be used as a basis for approval, in labeling decisions, and that the information be made available to patients and providers.

This draft guidance addresses many of the concerns raised previously by coalition members, and we are concerned that the FDA has continued to approve devices that were not analyzed in subgroup analysis proving that benefits outweigh the risks for women, people of color, and people over 65.  If FDA continues to approve/clear devices without subgroup data, then many medical device companies will ignore this guidance, as they often have in the past.  While guidances are not enforceable, FDA has the authority to refuse to approve medical products that have not been adequately tested on representatives of the population that will rely on them.  For example, if the FDA clearly states that a sponsors’ applications will be rejected — or perhaps approved only for the population that was adequately tested in subgroup analyses of safety and effectiveness, we are confident that companies will find a way to comply.

 

Below are our specific comments on the guidance:

 

Analyses should focus on each subgroup independently

Analyses should focus on whether a device is safe and effective for each subgroup independently, rather than whether there is a difference between groups.

Differences in safety and effectiveness between subgroups are much less important than whether benefits outweigh the risks for each subgroup.  For example, in a study of 20,000 patients, it is possible that a small difference between racial groups would be statistically significant for a device that is very effective for both all races.  But, for patients, that small difference would not matter.  What matters is not that they differ, but whether or not the device is useful for all racial groups.

Another reason why comparisons between or among groups is not sufficient is that smaller sample sizes result in wider confidence intervals. Therefore, the subgroups with fewer patients have a greater chance of appearing not significantly different from the other groups.  This would mask much of the meaningful information about safety and effectiveness in specific subgroups.  The guidance recommends device makers engage in “consultation with FDA” when sample sizes are not large enough.  This unfortunately will result in subjective case-by-case reviews, which can result in bias as well as being labor and resource-intensive for CDRH, which is under-funded. If the FDA believes such case-by-case reviews are needed, industry should pay for them through generous user fees.  Such “consultations” should not be funded by appropriations that are already inadequate for CDRH.

 

Analysis by age

The guidance notes that different age populations are “often underrepresented” in clinical trials for medical devices, and it cited the 2013 FDASIA 907 report that found “only 40%” of approved PMAs “reported an age based analysis of outcome data” and that age information was inconsistent and not detailed enough.  Medical device companies must provide more and better data. The guidance states that “older patients may have age-related covariates” (less bone density, slower metabolisms, and digestion issues) “that could affect the performance of medical devices.”   It also notes that pediatric subgroups are affected differently by medical devices “due to the size of the implant,” and that they are more “radiosensitive than adults.”

We agree with the guidance’s recommendation that studies should use more discrete age categories in performing subgroup analyses.  Even though FDA does not define a specific age for the geriatric population, we strongly urge that devices intended to be used by older patients should include an analysis of patients who are over 65 separately from younger adults.  FDA has expressed an interest in harmonizing with the Centers for Medicare & Medicaid Services (CMS), and since most Medicare patients are 65 and older, research evidence that a device is safe and effective in this age group would benefit patients, companies, and CMS.

 

Analysis by race, and ethnicity

The guidance notes that the U.S. population is becoming more diverse, yet subgroup representation in clinical trials “remains a challenge and inconsistent analysis and reporting contributes to persistent lack of publicly available data on device performance in diverse ethnic and racial groups.” The FDASIA 907 Report showed that “only 27% of the studies reviewed contained a race or ethnicity subgroup analysis and only 16% had public statements” regarding the subgroups.  Recent analyses by the National Center for Health Research found that this continued to be a problem for devices FDA reviewed in 2015.  It is critical that racial and ethnic subpopulations be adequately represented in clinical trials in order to ensure that the tested product is safe and effective for all the subpopulations that are likely to use that product.

 

Postmarket submissions

The guidance states that “consideration should be given to whether market approval/clearance is supported for the general population, with postmarket studies to gain further information regarding any observed…subgroup differences.” We urge FDA to require subpopulation data be analyzed before the device is marketed and that the focus be on benefits outweighing risks for each subgroup, rather than comparing subgroup differences.

Once a device maker has its product on the market, there is no incentive for them to do postmarket studies in a timely manner (or to complete them at all) since their device has already been approved/cleared by the FDA.  Additionally, the guidance notes there are “concerns about disproportionate dropout and loss to follow-up [which] are potential barriers to diverse study representation of minorities and older patients.”  For that reason, companies need to create incentives to keep patients in their studies.  If those studies are not completed appropriately, the FDA should rescind approval.

 

Unplanned subgroups analyses

We agree with the guidance that “unplanned subgroup analyses or those with inadequate sample size are generally not considered to be adequate to support statements in the labeling regarding the safety or effectiveness of the device.”  We suggest deleting the word “generally” from that sentence.

 

Device labeling

We agree with the guidance that “when clinically relevant differences in treatment effect are anticipated across age, race, or ethnic groups, these effects should be considered in the study design and…device labeling.”  However, as stated above, it is not sufficient to only consider such issues when subgroup differences are anticipated – they should always be considered.  In addition, also as stated above, subgroup differences are not the key issue; what matters to patients and providers is how safe and how effective devices are for patients in each subgroup.

In addition, we are concerned that patients will never see the label for the devices implanted in their bodies (hips and knees, for example).  Even more disturbing, surgeons have told us that they do not see the medical device labels either. FDA should investigate whether or not surgeons actually see and read the device labels, or if the labels are removed before surgeons receive the devices in the operating room.

 

“Snapshots” for medical device trials

Although it is beyond the scope of this guidance, the FDA should consider creating an equivalent to the FDA Drug Trials Snapshots for medical devices. This would make demographic subgroup data more available and transparent to the public.

 

Conclusions

To ensure that medical devices intended for use by the entire U.S. population are safe and effective for all relevant subgroups, FDA needs to require device makers to include more diverse populations in their analysis of clinical trials, and needs to require that subgroups be large enough to analyze to determine how safe and how effective a device is for each major subgroup population.   If a device is not safe and effective for all target groups, then labels should say that and approval indications should be restricted to those populations for whom benefits outweigh the risks.  Otherwise, doctors and patients will not have the information needed to make decisions about whether to use the device for treatment.

We are disappointed that this guidance, like other FDA documents, continues to miss the essential issues regarding subgroup analyses: to answer the question of how safe and how effective is this device for each major subgroup.   We strongly urge the FDA to require that safety and effectiveness be analyzed separately for each subgroup instead of just comparing safety or effectiveness between or among subgroups.  Companies need to collect sufficient information to evaluate the benefit/risk profile for each subgroup independently.  That will make it possible to determine if medical devices are sufficiently safe and effective for anyone who uses them.

Without these changes, the guidance will not help ensure that patients and providers have the information they need to determine if a device is likely to be safe or effective for a wide range of patients in terms of age, race, and ethnicity.  Moreover, it is crucial that FDA hold device makers accountable by not approving devices for all Americans if it has not been proven to have benefits that outweigh the risks for all major subgroups that will use those devices.

 

American Medical Student Association

American Medical Women’s Association

Breast Cancer Action

Breast Cancer Consortium

Connecticut Center for Patient Safety

MRSA Survivors Network

National Center for Health Research

National Organization for Women

Our Bodies Ourselves

The TMJ Association

Washington Advocates for Patient Safety

WoodyMatters

 

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org

[1] Food and Drug Administration (2014).  Guidance: Evaluation of Sex Specific Data in Medical Device Clinical Studies. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283707.pdf

[2] Food and Drug Administration (2016).  Draft guidance: Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM507278.pdf

Coalition strongly urges the FDA to ban the use of certain phthalates in food packaging

September 19, 2016

 

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

 

 

Comments of members of the Patient, Consumer, and Public Health Coalition

on

The Food Additive Petition Filed by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council;

  [Docket No. FDA-2016-F-1253]

 

Members of the Patient, Consumer, and Public Health Coalition strongly support the food additive petition to amend or revoke food additive regulations regarding food processing and packaging involving specific  phthalates.[i]  We strongly urge the FDA to ban the use of these ortho-phthalates for use in the production, storage, and packaging of food.

 

More commonly known as phthalates, ortho-phthalate metabolites are detectable in nearly everyone in the U.S.,[ii] primarily because of the food we eat.[iii] While exposures to specific phthalates may be low for many individual foods, they are present in a wide variety of foods and so the cumulative level is much higher.[iv], [v], [vi]

 

Phthalate exposure can have diverse and long-lasting harms. Phthalates such as DEHP are probable human carcinogens.[vii] Exposure before birth and during early life has been linked to numerous problems with brain development. These include Attention Deficit Hyperactivity Disorder (ADHD) related behaviors, impaired social behavior, aggression, depression, and lower IQ.[viii] Increased exposure causes reproductive problems for both sexes, including abnormal testicle development and preterm birth.[ix]

 

Eleven phthalates have been found to affect reproductive, developmental and endocrine health, and the remaining substances do not have sufficient evidence to judge their safety As such, it is impossible to conclude that there is “reasonable certainty of no harm.” We agree with the petitioners that phthalates should be addressed as a class because if phthalates are considered on an individual basis, one harmful phthalate will likely replace another harmful one. Phthalates contaminate food at different stages of production and storage.[x] We support the extensive scope of the petition to cover all of the steps in processing and packaging of food.

 

We note that government agencies have already banned or limited the use of certain phthalates covered by this food additive petition. The Consumer Product Safety Commission has banned the use of six of these phthalates from children’s toys and other products due to these health concerns for this vulnerable population.[xi] The FDA already limits/warns about the use of DEHP in medical devices[xii] and DEHP and DBP in drugs.[xiii] Clearly, the same chemicals in our food is potentially even a greater risk.

 

Conclusions

Our Coalition and member groups have commented or testified to the FDA on phthalates and food contact issues for several years. In 2010, members of our coalition submitted comments in support of the FDA’s proposed rule regarding allowable DEHP levels in bottled water (see Docket NO. FDA-1993-N-0259).

 

The National Center for Health Research’s Dr. Anna Mazzucco spoke at the December 9, 2014 FDA meeting on expanding the Redbook to enhance the safety of food and products. Dr. Mazzucco noted that “Current evaluation of food additives for carcinogenic activity is narrowly focused on genotoxic mechanisms of action.  She added that the FDA should add tests for endocrine disruption to its toxicological evaluation of food contact substances and additives to ensure that all food contact substances, both old and new, are safe.”

 

In summary, we agree with the March 18, 2016 letter from the Natural Resources Defense Council and other groups to the Center for Food Safety and Applied Nutrition. The letter states that “there is no longer a reasonable certainty of no harm for the food contact use of the 30 phthalates.” We echo their concerns that exposure levels to U.S. citizens of these phthalates are above the tolerance for the class of chemicals. The FDA should ban the use of phthalates for use in the production and storage of food.

 

American Medical Student Association

American Medical Women’s Association

Breast Cancer Action

Breast Cancer Consortium

Mothers Against Medical Error

MRSA Survivors Network

National Center for Health Research

National Consumers League

National Organization for Women

Our Bodies Ourselves

Washington Advocates for Patient Safety

 

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at pb@center4research.org or at (202) 223-4000.

[i] Federal Register (May 20, 2016). Food and Drug Administration, notice of petition. Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition.

[ii] National Health and Nutrition Examination Survey (NHANES) (October 2014). Phthalates and plasticizers metabolites- Urine (PHTHTE_G); years of content 2011-2012. http://wwwn.cdc.gov/Nchs/Nhanes/2011-2012/PHTHTE_G.htm

[iii] Consumer Product Safety Commission (July 2014). Chronic Hazard Advisory Panel On Phthalates and Phthalate Alternatives.https://www.cpsc.gov/PageFiles/169876/CHAP-REPORT-FINAL.pdf

[iv] Sathyanarayana S et al (2013). Unexpected results in a randomized dietary trial to reduce phthalate and bisphenol A exposures. J Expo Sci Environ Epidemiol. 23(4):378-384.

[v] Schecter A et al (2013). Phthalate concentrations and dietary exposure from food purchased in New York State. Environ Health Perspect. 121(4):473-479. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3620091/

[vi] Serrano SE, Braun J, Transande L, Dills R, Sathyanarayana S (2014). Phthalates and diet: a review of the food monitoring and epidemiology data. Environ Health 13:43.

4 Agency for Toxic Substances and Disease Registry (2002).  Toxicological profile for di (2-ethylhexyl) phthalate.  Update. Atlanta, GA:  U.S. Department of Health and Human Services, Public Health Service.

[viii] Ejaredar M, Nyanza EC, Ten Eycke K, Dewey D (2015). Phthalate exposure and children’s neurodevelopment: A systematic review. Environ Res 142:51-60.

[ix] Marie C, Vendittelli F, Sauvant-Rochat MP (2015) Obstetrical outcomes and biomarkers to assess exposure to phthalates: A review. Environ Int. 83:116-136.

[x] Fierens T, Van Holderbeke M, Willems H De Henauw S, Sioen I (2013). Transfer of eight phthalates through the milk chain — A case study. Environ Int. 51:1-7.

[xi] US Consumer Product Safety Commission. (July 2015). Phthalates. http://www.cpsc.gov/en/Business–Manufacturing/Business-Education/Business-Guidance/Phthalates-Information.

[xii] US Food and Drug Administration (July 2002). FDA public health notification: PVC devices containing the plasticizer DEHP. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062182.htm.

[xiii] US Food and Drug Administration (December 2012). Limiting the use of certain phthalates as excipients in CDER-regulated products. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm330792.htm

Comments to FDA on how device makers can avoid sending “confusing or unclear information” to patients

August 9, 2016

 

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852.

 

 

Comments of members of the Patient, Consumer, and Public Health Coalition

on the draft guidance

Dissemination of Patient-Specific Information from Devices by Device Manufacturers

[Docket No. FDA-2016-D-1264]

 

 

Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance Dissemination of Patient-Specific Information from Devices by Device Manufacturers.  We generally support the draft guidance but the document needs further clarification, especially the paragraph on the Health Insurance Portability and Accountability Act (HIPAA).

The purpose of the draft guidance is to “clarify that manufacturers may share with a patient  patient-specific information” collected from devices regarding that same patient.  In other words, device companies may share with a patient the information that the device collects about him or her. The draft guidance defines “patient-specific information” as including “recorded patient data, device usages/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures.”[1] We agree with FDA that providing the above information “will empower patients to be more engaged with their healthcare providers in making sound medical decisions.”1

Content

FDA recommends that device makers take steps to avoid “disclosure of confusing or unclear information that could be misinterpreted” by patients. The draft guidance does not provide details on how device makers should accomplish this goal.  If the information from the device is summarized, key data could be omitted. Alternatively, if all data is released (e.g. via data dump), the information could be overwhelming and useless to the patient.

Information communicated to patients should be done in a manner that is easy for them to understand.  Only 12 percent of adults have proficient health literacy, according to the National Assessment of Adult Literacy.[2]  This indicates that many patients may not be able to understand information that is complicated or communicated using medical terminology. Patients benefit from interactive, simple to follow, and practical communications that are appropriate to the intellectual and social skills of the patient and the caregiver.[3]

FDA notes that device makers “may share patient-specific information…with patients at the patient’s request without obtaining additional premarket review before doing so.” FDA then cautions that additional information from devices shared with patients by the manufacturer could meet the definition of labeling and would be subject to FDA labeling regulations. Although FDA cites the labeling section of the Federal Food, Drug, and Cosmetic Act (section 201 (m)), the draft guidance does not provide an example of when information shared from a device would meet the labeling definition.

FDA states that often the patient-specific information is “accessible by the patient’s healthcare providers,” or patients may contact the manufacturer directly to obtain the information.  The advantage of receiving the information from a healthcare provider is that the information will more likely be interpreted and put in context, and the patient can ask follow-up questions.   The disadvantage is that the patient will have to pay for the appointment, and may not be able to access the information in a timely manner.

We agree with FDA that patient-specific information shared with patients should be “comprehensive and contemporary” and the information from a patient’s blood pressure device provides a good example. But again, we are concerned that “comprehensive” could become a useless “data dump.”

Context

We agree with FDA that patient-specific information should include “relevant context” so that the information will not be misinterpreted, “thus leading to incorrect or invalid conclusions.” Invalid conclusions could lead to additional tests (i.e. over diagnosis), or false negatives, which could put the patient’s health at risk. We also agree with FDA that device makers who provide patient-specific information should include information “about whom to contact for follow-up information.”

 HIPAA

The draft guidance dedicates one paragraph to HIPAA.  It notes that HIPAA protections apply to device makers to prevent the sharing of “individually identifiable health information” but the protections “are not intended to prevent a device manufacturer from sharing patient-specific information with the affected patient.”

A recent article criticized FDA’s definition of “Patient-specific information” because it “appears to be, at least in part, inconsistent with HIPAA’s definition” of Protected Health Information (PHI). The article also notes that “there are a number of instances where a device manufacturer may be a HIPAA-regulated entity.”[4] For example, if a medical device company has contracted with a covered entity (such as a doctor’s office or hospital) so that the device will transmit electronic protected health information directly to the provider, compliance with HIPAA requirements is mandated.[5] This type of scenario is not addressed in the draft guidance.

Others have noted that the guidance appears to offer an incorrect interpretation of HIPAA when it states that device manufacturers are prevented under HIPAA from sharing this information with covered entities, such as health plans and health-care providers that electronically transmit health data, without the patient’s consent.[6]  We agree  that HIPAA was never meant to prohibit patient data collected by devices from being shared with the patients’ own physicians. Clarification of these issues is needed.

Also, nothing is mentioned about encrypting sensitive personal health information, or the risk of data breaches.  The draft guidance should recommend steps device makers can take to mitigate the risk of data breaches, and to make sure the information is not compiled in any databases that are shared with health plans or healthcare providers.

Conclusions

We generally support this brief draft guidance but the HIPAA section needs clarity, and Content section needs more details on how device makers can avoid disseminating “confusing or unclear information” to patients.

 American Medical Women’s Association

Breast Cancer Action

Connecticut Center for Patient Safety

MRSA Survivors Network

National Center for Health Research

National Consumers League

Our Bodies Ourselves

The TMJ Association

Washington Advocates for Patient Safety

 

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or pb@center4research.org

 

[1] Food and Drug Administration (June 10, 2016).  Dissemination of Patient-Specific Information from Devices by Device Manufacturers; Draft Guidance of Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm505756.pdf

[2] Quick Guide to Health Literacy. US Department of Health and Human Services. https://health.gov/communication/literacy/quickguide/factsbasic.htm

[3] Schooley B, San Nicolas-Rocca T, Burkhard R. Patient-provider communications in outpatient clinic settings: a clinic-based evaluation of mobile device and multimedia mediated communications for patient education. JMIR Mhealth Uhealth. 2015 Jan 12;3(1):e2. http://www.ncbi.nlm.nih.gov/pubmed/25583145

[4] Weinrieb JM, Weeda JM (June 15, 2016). FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data—But Doesn’t Say Much About HIPAA.  OFW Law. http://www.ofwlaw.com/2016/06/15/fda-publishes-draft-guidance-dissemination-patient-specific-data-doesnt-say-much-hipaa/

[5] Hartford, J (August 25, 2015). Are your medical devices HIPAA compliant? MDDI DeviceTalk. http://www.mddionline.com/blog/devicetalk/are-your-medical-devices-hipaa-compliant-08-25-15.

[6] Williamson MD (June 13, 2016). FDA Guidance on Device Data Sharing Aligns With HIPAA: Attorney. Bloomberg BNA. http://www.bna.com/fda-guidance-device-n57982074036/

 

Coalition urges FDA to protect patients & consumers by requiring biosimilar companies to update their labels when safety issues arise

August 2, 2016

 

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

 

 

Comments of members of the Patient, Consumer, and Public Health Coalition

on

Labeling for Biosimilar Products; Draft Guidance

[FDA-2016-D-0643]

 

Members of the Patient, Consumer, and Public Health Coalition support the Food and Drug Administration’s (FDA) draft guidance on “Labeling for Biosimilar Products.”  The draft guidance will protect patients and consumers by requiring biosimilar companies to update their labels when safety issues arise.

Background

The Biologics Price Competition and Innovation Act of 2009, signed into law as part of the Affordable Care Act, created an abbreviated pathway to license biosimilar products.[i] A product is a biosimilar if it has no clinically meaningful differences compared to the reference product in terms of “safety, purity, and potency.”1 Because there is no meaningful difference, we agree with the FDA that biosimilars labeling should include a description of the clinical data that supported safety and efficacy of the reference product.  We agree with FDA that the biosimilar prescribing information (package insert) relies mainly on the safety and effectiveness information from the labeling for the reference product.[ii] 

Specific Recommendations on Content of Biosimilar Product Labeling

FDA also notes that biosimilar products’ labels may differ from the reference product labeling (have “appropriate product-specific modifications”) in order to conform to the Physician Labeling Rule (PLR) and the Pregnancy and Lactation Labeling Rule (PLLR), and other safety issues.  We agree since this will add to the safer use of biosimilars.  Also, according to a recent survey of European physicians, they “prefer more product-specific information in the biosimilar label.”[iii]

 Revising Biosimilar Product Labeling

We strongly agree with the FDA that “all holders of marketing applications for biological products have an ongoing obligation to ensure their labeling is accurate and up to date” (emphasis added).1  We see no reason why this should not include PLR and PLLR information for the reference product. To ensure that the product is used safely, both the reference product and the biosimilar product application holders must be able to update their labeling.

 Conclusions

We strongly support the “Labeling for Biosimilar Products” draft guidance.  It will protect patients and consumers by ensuring the important labeling safety information is updated for both biosimilars and the reference products.

American Medical Student Association

American Medical Women’s Association

Center for Medical Consumers

Connecticut Center for Patient Safety

MAME

MRSA Survivors Network

National Center for Health Research

National Physicians Alliance

National Women’s Health Network

Quinolone Vigilance Foundation

Washington Advocates for Patient Safety

WoodyMatters

 

 The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org

 

[i] Federal Register (April 4, 2016). Food and Drug Administration draft guidance “Labeling for Biosimilar Products.”

[ii] Food and Drug Administration (April 1, 2016).  News & Events Form our perspective: Biosimilar product labeling.

http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 2/3

[iii] Hallersten AFürst WMezzasalma R (June 2016). Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries.  Regul Toxicol Pharmacol. 

http://www.ncbi.nlm.nih.gov/pubmed/27041395

Coalition Members Strongly Support FDA’s Proposed Ban on Inhumane Electrical Stimulation Devices

July 25, 2016

 

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852.

 

 

Comments of members of the Patient, Consumer, and Public Health Coalition on

Proposed Rule To Ban Electrical Stimulation Devices Used To

Treat Self-Injurious or Aggressive Behavior

[Docket No. FDA-2016-N-1111]

 

Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to ban electrical stimulation devices (ESDs)* used to treat self-injurious behavior (SIB) or aggressive behavior (AB). ESD treatments are ineffective and have serious side effects, and there are alternative, less stressful treatments available.

The goal of ESDs is to reduce self-injurious or aggressive behavior by punishing it with shocks.  However, the strategy of preventing violent behavior in any situation by using a painful punishment is rejected by most experts.  That is why the overwhelming majority of SIB and AB patients are not treated with ESDs.  Only one facility in the U.S. manufactures and uses ESDs, the Judge Rotenberg Educational Center, Inc. (JRC). Even if ESDs were a safe, effective, and humane treatment, those used by JRC as recently as 2012 had not been cleared by the FDA. FDA has sent warning letters to the Center at least three times stating that the devices are in violation of FDA regulations because they have been modified to increase the voltage they provide but a new application has not been filed with the FDA.[i], [ii]

Because of advances in human rights and behavioral therapy, nearly half of the States prohibit the use of ESDs.[iii] The United Nations has said use of ESDs, such as those used by the Rotenberg Center, constitutes a violation of the UN Convention Against Torture, and would not be legal if used even against convicted terrorists.[iv], [v]

Risks

ESDs have a long list of harms including “depression, PTSD, anxiety, fear, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness, as well as the physical risks of pain, and skin burns.”3 The devices are associated with an increased risk of “suicidality, chronic stress, neuropathy, and injuries from falling.”3  They are associated with “nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and withdrawal from usual activity.”3

We agree with the FDA that adverse events are likely to be under-reported because the children and adults subjected to ESD often have problems that make it difficult to persuasively communicate to anyone who would be likely to report adverse events to the FDA.   In addition, the individuals administering ESDs are unlikely to be taught or encouraged by their employer (who requires them to administer ESDs) to report adverse events resulting from ESD “treatment.”

Benefits

Although the scientific literature reports that ESD shocks can immediately interrupt SIB or AB, these studies have been criticized for “weak study design, failure to control for concomitant treatments, small size, lack of peer review, and conflicts of interest.”3  We agree with the FDA that “the evidence is inadequate to establish that ESDs improve individuals’ underlying conditions or…reduce or cease the target behavior to achieve durable long-term reduction of the target behavior.” The established risks are even more unacceptable given the lack of evidence of benefits.

Alternative treatments

There is clear research evidence that positive reinforcement is more effective and longer-lasting than negative reinforcement (punishment).  We agree with the FDA that positive-based behavioral approaches are effective at reducing self-injurious and aggressive behavior, providing greater benefits and less risk than ESDs.  We also agree with the FDA that “addressing the underlying causes of SIB and AB…rather than suppressing behaviors with shocks not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits.”

Conclusions

ESDs are not established to be effective for most self-injurious or aggressive behaviors and represent a substantial and unreasonable risk of injury.  They are also inhumane. For the above reasons, we strongly support the ban on electrical stimulation devices.

American Medical Women’s Association

MAME

MRSA Survivors Network

National Center for Health Research

National Physicians Alliance

Washington Advocates for Patient Safety

WoodyMatters

 

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or pb@center4research.org

*We are aware that ESDs are not used in electroconvulsive therapy (ECT or electroshock therapy) and that this proposed rule does not apply to ECT devices.

 

[i] Willingham E (April 22, 2016).  FDA Proposes Ban On Electric Shock Devices Used On Autistic Children. Forbes. http://www.forbes.com/sites/emilywillingham/2016/04/22/fda-seeks-to-ban-electric-shock-devices/#7e7c39e87ead

[ii] Food and Drug Administration (December 6, 2012).  Inspections, Compliance, Enforcement, and Criminal Investigations: Warning Letter CMS#367480, the Judge Rotenberg Educational Center. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331291.htm

[iii] Federal Register (April 25, 2016). Food and Drug Administration: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule. [Docket No. FDA-2016-N-1111] https://www.federalregister.gov/articles/2016/04/25/2016-09433/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or

[iv] Ahem, L (October 2, 2010). Disabled children at Mass. School are tortured, not treated. The Washington Post. http://www.washingtonpost.com/wp-dyn/content/article/2010/09/17/AR2010091705376.html

[v] Burkholder A (August 5, 2014). Controversy over shocking people with autism, behavioral disorders. CBS News. http://www.cbsnews.com/news/controversy-over-shocking-people-with-autism-behavioral-disorders/

Coalition Urges FDA to Improve Draft Guidance for Using Electronic Health Records in Clinical Studies

July 18, 2016

Food and Drug Administration

Division of Dockets Management (HFA-305)

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

 

Comments of members of the Patient, Consumer, and Public Health Coalition

on the draft guidance

Use of Electronic Health Record Data in Clinical Investigations

[Docket No. FDA-2016-D-1224]

 

A major goal of the draft guidance is to “facilitate the use of EHR data in clinical investigations.”1  Although EHRs are not under the direct control of the FDA (the systems belong to healthcare organizations and institutions that use them), the Agency does need to develop a clear process for accepting EHR data for use in clinical investigations.  The draft guidance is a step in the right direction but needs to better address key issues.

The draft guidance addresses how the FDA will ensure the EHR data’s validity, reliability, and integrity, and how the agency will verify the integrity of the EHR data during on-site inspections and audits of the organizations that control the data.

On-site inspections

We agree with the draft guidance that clinical investigators must retain all paper and electronic source documents for as long as required by regulations, and EHR data must meet FDA’s inspection, record keeping and record retention requirements.  And, importantly, study monitors must have “suitable access to all relevant subject information pertaining to a clinical investigation.” 2

However, we are concerned that the draft guidance does not mention how often FDA will do on-site inspections.  If FDA does not establish a schedule of on-site inspections, they may never be done and this could lead to poor quality data.

Quality and integrity

The draft guidance states that “when EHRs are used as a source of data in clinical investigations, sponsors should ensure that the data are ‘attributable, legible, contemporaneous, original and accurate (ALCOA).’”  If the data does not meet all five of these attributes, will the data be rejected by the FDA?

An inherent problem with using EHRs for clinical investigations is that EHRs are currently designed to assist in delivering health care — not to generate medical evidence.  A July 2016 Article in JAMA Internal Medicine notes that “practices like blinding, randomization, or standardized-event recording are more difficult to implement in systems that are oriented toward care.  Health care systems represent inefficient environments to which to learn about differential effects of novel drugs.”3 The draft guidance notes that the use of EHRs for clinical investigations may require additional “considerations, planning, and management” but it does not go into detail on how to accomplish this.

The draft guidance recommends, but does not require, the use of certified EHR technology.  The U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) has a voluntary certification program for health IT.  EHR technology certified by ONC’S Program meets privacy and security protection requirements.

The draft guidance allows EHRs not certified by ONC to be used for clinical investigations as long as they include adequate controls such as limiting access to the electronic systems, identifying the authors of records, providing audit trails, ensuring records are retained for FDA inspections, and assuring patient privacy rights.  Although the adequate controls address key issues, there would be more consistency in investigations, if all EHRs for clinical investigations were required to use certified EHR technology.

In using EHRs for clinical investigations, the draft guidance recommends that extracted data is checked for consistency and completeness.  It also recommends that corrections be made when errors are found “to properly align the source data with the extracted data.”  We are concerned that unless FDA spot checks the data, errors will not be corrected.

The draft guidance notes that software updates could “affect the reliability and integrity of EHR data entering the sponsor’s electronic system.”  This is a major concern.  A recent review of FDA data by the National Center for Health Research found that over the last 5 years, more than 600 different software devices totaling over 1.4 million units were recalled for moderate or high risk patient safety issues.  For example, oncology electronic medical record systems were recalled because they erroneously switched patient data and failed to warn physicians about dangerous drug reactions.

Interoperability & audit trails

The draft guidance encourages the use of interoperable systems in order to “reduce errors in data transcription and provide data that is more accurate.”  We agree that interoperability will reduce transcription errors but if the data was incorrect to begin with, it will not provide more accurate data.

The draft guidance states that adequate methods of audit trails are needed to monitor, track and document all changes made to information in the EHR regarding the clinical investigation. However, the draft guidance fails to define the phrase “adequate methods.”

One of the major risks associated with EHRs are data breaches.  Data breaches could negatively affect a subject’s employment or ability to get insurance.  The draft guidance states, “Sponsors should consider whether there are any reasonably foreseeable risks with the use of EHRs…that must be described to the subject in the informed consent.”  We recommend that the risk of data breaches be communicated to subjects at least twice—once in writing and once again verbally.

Conclusions

EHRs can provide investigators “access to real-time and longitudinal health care data”1and can provide post-trial follow-up information on safety and efficacy of medical products.  However, we think this draft guidance still needs work.  It does not address how inaccuracies in the data will be corrected, how often FDA will do on-site inspections, and ways to mitigate the risks of data breaches.

American Medical Women’s Association

MRSA Survivors Network

National Center for Health Research

Our Bodies Ourselves

Quinolone Vigilance Foundation

Washington Advocates for Patient Safety

 

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or pb@center4research.org

Letter Urging Senators to Protect Patient Safety in Innovation Health Bill & Provide Mandatory $$$ for NIH & FDA

May 24, 2016

The Honorable #{Fname} #{Lname}

United States Senate

Washington, DC 20510

 

Dear Senator #{Lname},

A recent STAT-Harvard poll shows that a majority of Americans oppose changing federal regulations to speed the development and approval of new medical products. They are concerned that speeding approvals would lower safety and effectiveness standards for medical products.4 As members of the Patient, Consumer, and Public Health Coalition, we share those concerns.  We also write to emphasize that any effort to develop safe and effective medical products should include mandatory new funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

The House’s 21st Century Cures Act and its Senate companion legislation should focus more on ensuring that medical products are safe and effective and less on speeding medical products to the market. We appreciate that the Senate bills were less dangerous for patients than the House legislation. But, we opposed 6 of the 19 bills that the Senate passed out of the HELP Committee because they were not beneficial to patients.

When these bills (which we’ve listed below) reach the Senate floor, we strongly urge you to oppose them because they weaken FDA’s safety and effectiveness standards.

 Current and former FDA Commissioners have expressed their concerns as well. Current FDA Commissioner, Robert Califf recently said, “This legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm.” 5 Former FDA Commissioner David Kessler, who in the 1990s led the FDA under presidents from both parties, said, “It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered.”6

The underlying premise of the House and Senate bills seems to be that the FDA needs to speed up its approval process. This premise is based on the erroneous claim that other countries approve medical products more quickly. Nearly two-thirds of the novel drugs approved in 2015 (29 of 45, 64%) were approved in the United States before being approved in any other country.7 In fact, a Forbes article expressed concern that the pendulum has swung too far and that “the FDA is basically providing a rubber stamp” for drug approvals and that drug approvals are at an all-time high.8 Similarly, research indicates that “it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices” in the U.S. as compared to Germany, France, Italy, and Britain.9 Approximately 99% of all regulated medical devices are cleared by the FDA through the speedy and less-than-rigorous 510(k) process, and the FDA reviews 90% of those applications within 90 days.10 With the emphasis on speed over safety it is not surprising that millions of Americans have been harmed needlessly from defective medical devices such as surgical mesh, metal-on-metal hips, power morcellators, duodenal scopes, birth control devices (Essure), and inaccurate medical device software. It is clear that we need stronger device safety regulations and better postmarket surveillance. When there are problems with medical devices in the real world, patients need to be notified as soon as possible.

Members of our coalition are particularly concerned about the following bills:

MEDTECH Act (S. 1101)

The MEDTECH Act deregulates Electronic Health Records (EHRs) and other electronic health technology. This prevents the FDA from collecting adverse event data or recalling defective software, even when the devices have life-threatening flaws.  The National Center for Health Research studied FDA-reported recalls of medical software, identifying more than 600 software devices and 1.4 million units recalled for moderate or high risk patient safety issues.  They found that if medical software is removed from FDA regulatory oversight, millions of patients would be at risk from defective software. For example, oncology electronic medical record systems were recalled in the past because they calculated and recorded incorrect drug dosages. Clinical decision support systems used during surgery were recalled because they erroneously switched patient data and failed to warn physicians about dangerous drug reactions.

Advancing Breakthrough Devices for Patients Act (S. 1077)

This bill would set a low bar for medical devices to qualify for breakthrough status, and encourage shorter or smaller clinical trials, which would make it difficult if not impossible to include subpopulations (women, seniors, racial and ethnic minorities) in the analysis of the trials. The bill would also push FDA to rely on post-market studies rather than ensuring safety or effectiveness before hospitals and patients pay for the devices. A 2015 GAO report found that most required post-market device studies are never completed. In other words, if this bill passes, there would be no conclusive evidence pre-market or post-market.

The Advancing Hope Act (S. 1878)

Priority review vouchers allow FDA priority reviews to go to the highest bidder rather than allowing the FDA to prioritize matters of the most public health importance.  The bill’s priority review vouchers would be applied to drugs that are already in development rather than spurring new drugs because of the long drug development cycle.

The Medical Countermeasure Innovation Act (S. 2055)

This bill establishes a new priority review voucher program for medical countermeasures (e.g. antidotes to anthrax and other bioweapons). As with existing priority review voucher programs, it does not necessarily reward innovation and prevents FDA from prioritizing matters of greatest public health importance.

The Combination Product Regulatory Fairness Act (S. 1767)

This bill would broaden the ability of combination products to be classified as devices.  This would inappropriately allow products that should be classified as drugs to go through the FDA’s less rigorous device clearance/approval process.

Patient Focused Impact Assessment Act (S. 1597)

The Patient Focused Impact Assessment Act adds a new layer of bureaucracy to the FDA, does not provide safeguards to ensure that patient perspectives will be free of industry influence, and may provide a mechanism for industry to promote drugs directly to consumers for off-label uses.

REGROW Act (S. 2689)

The REGROW Act is the latest effort to lower research standards and deregulate new treatments. Although this bill was not part of the HELP Committee markups held earlier this year, we understand it might be added to a package bill. The Act allows complex biologic therapies to be conditionally approved without phase III trials and prescribed to patients based on studies in a limited population without proof that the new therapy actually works. If this Act passes, it could lead to the Centers for Medicare and Medicaid (CMS) wasting billions of dollars on medications that were approved by the FDA but do not work.

The Alliance for Regenerative Medicine (ARM) does not support the REGROW Act, because those researchers want  “to ensure access to safe and effective regenerative medicine therapies without putting patients at risk, disadvantaging American therapeutic developers and potentially damaging a very promising field of medicine”(emphasis added).[7]  In her recent article about stem cell research in the New England Journal of Medicine, University of Wisconsin law professor and biomedical ethicist R. Alta Charo said, “The best way to find safe effective cures is through the careful steps of clinical trials and treatment monitoring.”11

 For the remaining Senate FDA-NIH bills, we urge you to only support them if they provide mandatory new funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).   If mandatory funding is not included, we strongly urge you to vote against the bills.

 Funding for NIH & FDA

Prior to last year’s $2 billion one-time funding increase, NIH’s funding remained flat for more than a decade (about $30 billion per year).12 Unfortunately, the Cures Act $9 billion increase in NIH research funding is still below what it would have been had Congress not previously allowed NIH’s annual budget to stagnate.13

The Cures Act also would provide the FDA with $550 million in new mandatory funding over five years, but the amount of money pales to the additional workload that the Act assigns to the FDA. New FDA Commissioner, Robert Califf, has warned that Congress needs to provide the FDA with an “adequate and stable source of funding” for the mandates in the legislation.14

Adequately funding NIH is essential if we are serious about the Vice President’s Cancer Moonshot, precision medicine, and efforts to find treatments for Alzheimer’s disease, autism, depression, schizophrenia, addiction and other maladies.15  Underfunding the FDA is likely to slow the approval of new medical products because the agency’s workload has been significantly increased with unfunded mandates.

Conclusions

Members of our coalition agree with most Americans in opposing regulations that would speed the approval of medical products by lowering FDA’s safety and effectiveness standards. We strongly urge you to oppose any bill that weakens FDA’s safety and effectiveness standards, and to ensure that any legislation aimed at improving medical treatments include new mandatory funding for the NIH and the FDA. 

AMWA

Breast Cancer Action

Center for Medical Consumers

Connecticut Center for Patient Safety

MAME

MedShadow Foundation

MISSD

MRSA Survivors Network

National Center for Health Research

National Consumers League

National Organization for Women

National Physicians Alliance

National Women’s Health Network

Quinolone Vigilance Foundation

The TMJ Association

Washington Advocates for Patient Safety

WoodyMatters

Policy Positions

Featured

Policy positions in the form of letters, public comments, media releases, etc., will be reviewed by all members allowing each organization to “opt in or out,” depending on the mission, policies, focus, and involvement of those organizations.  Here is a sample of recent communications that reflect the views of the organizations that have signed on to them.  
Coalition Letter Protesting 21st Century Cures (11/30/2016) - We are writing to urgently express our strong opposition to the newly revised 21st Century Cures Act, both in terms of the process of trying to pass a bill without adequate time for public debate, and for specific provisions in the bill that would harm patient safety. Continue reading
Testimony to FDA panel on consideration of off-label promotion of medical devices (11/15/2016) - November 10, 2016 Thank you for the opportunity to speak today.  My name is Jack Mitchell, and I’m the director of government relations for the non-profit National Center for Health Research, which performs public health research and conducts patient advocacy. … Continue reading
Letter to Senators on the Innovation for Healthier Americans bills (11/8/2016) - We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA). Continue reading
Comments to FDA against removal of the black box warning for Chantix (9/16/2016) - Thank you for the opportunity to speak today. My name is Dr. Stephanie Fox-Rawlings and I am speaking on behalf of many members of the Patient, Consumer, and Public Health Coalition. The Coalition includes nonprofit organizations representing millions of patients, … Continue reading
Coalition Letter to Senators regarding the Senate’s Biomedical Bills (21st Century Cures companion legislation) (7/5/2016) - We want all Americans to have the best possible medical treatments but we are concerned that the primary focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective. Continue reading
Coalition letter urging Senators to oppose S. 2912, the Trickett Wendler Right to Try Act of 2016 (6/15/2016) - Right to Try laws such as S. 2912 will do more harm than good for patients and society. The bill is opposed by experts in the field as well as by legitimate drug companies. We urge you to oppose the Trickett Wendler Right to Try Act of 2016. Continue reading
Coalition’s comments to the FDA on User Fees for Over-the-Counter Drugs (6/14/2016) - We support the establishment of a user fee program for OTC drugs so that all OTC monographs can be finalized. We urge you to include funding in user fees to address emerging safety and effectiveness issues as well to reexamine use of certain OTC products in infants and children. Additional resources are critical to protect public health. Continue reading
Coalition Comments on FDA Draft Guidance for Generic Abuse-Deterrent Opioids (5/24/2016) - We agree with many of the recommendations in the guidance and urge the FDA to consider our recommendations regarding the use of the term “abuse-deterrent”, the development of guidance addressing additional abuse-deterrent technologies, the scrutiny applied to Tier 1 studies, and the enforcement of post-marketing study requirements for reference products. Continue reading
Coalition’s Comment the Black Box Warning and Patient Decision Checklist for Essure Birth Control System (5/5/2016) - May 3, 2016   Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852   Comments of members of the Patient, Consumer, and Public Health Coalition on the Draft Guidance “Labeling for Permanent … Continue reading
Coalition’s Comments on FDA’s Efforts to Improve Diversity and Analyses in Clinical Trials (5/5/2016) - April 29, 2016   Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852   Comments of members of the Patient, Consumer, and Public Health Coalition on FDA’s Efforts to Improve Diversity and … Continue reading
Coalition’s Comments on FDA’s Direct-to-Consumer Advertising Survey (5/5/2016) - April 29, 2016   Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852   Comments of members of the Patient, Consumer, and Public Health Coalition on the “National Direct-to-Consumer Advertising Survey Docket … Continue reading
Establishing Paid Sick Leave for Federal Contractors (4/8/2016) - We strongly support the proposed rule, Establishing Paid Sick Leave for Federal Contractors, which requires that employees that work on federal contracts are entitled to earn at least seven days or 56 hours of paid sick leave per year. Continue reading
Coalition Supports Proposal to Notify the Public About Emerging Safety Issues with Medical Devices (4/1/2016) - The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations. But in the months or even years during that delay, patients can be and too often have been seriously harmed. Continue reading
Comments on FDA’s Proposed Reclassification of ECT Devices for Treating Severe Major Depressive Episodes (4/1/2016) - We are writing to strongly oppose the split classification of electroconvulsive (ECT) devices. This reclassification would make ECT devices used for treatment-resistant major depression or depression requiring a rapid response class II (special controls) and all other psychiatric indications class III. Continue reading
Coalition Strongly Supports FDA’s Proposal to Regulate Over-the-Counter Sunscreens (3/28/2016) - Comments of members of the Patient, Consumer, and Public Health Coalition on the FDA Draft Guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data”  Docket No. FDA-2015-D-4021     As members of the Patient, Consumer, and Public Health Coalition, we appreciate … Continue reading
Comments in Support of FDA’s Proposed Updated Performance Standards for Tanning Devices (3/22/2016) - March 21, 2016 Comments on Proposed Rule Proposed Amendment to Performance Standard [Docket No. FDA-1998-N-0880] Since there are virtually no medical benefits to using commercial sunlamp products (tanning beds) and the World Health Organization’s (WHO) International Agency for Research on … Continue reading
Comments in Support of FDA’s Proposed Age Restrictions on Tanning Beds (3/22/2016) - March 21, 2016 Comments on Proposed Rule Restricted Sale, Distribution, and Use of Sunlamp Products [Docket No. FDA-2015-N-1765] As members of the Patient, Consumer, and Public Health Coalition, we strongly support the proposed rule that bans minors (individuals under the … Continue reading
Letter to HELP Committee Re: Innovation Bills (3/5/2016) - March 5, 2016 Dear Senator _______, As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our views as consumers, physicians, scientists, and public health experts regarding the health care legislation scheduled to be marked … Continue reading
Innovation for Healthier Americans: Materials from our Senate briefing (3/4/2016) - These are the materials from the Senate briefing we hosted on March 4, 2016 titled "Innovation for Healthier Americans: The Impact of Proposed Health Bills on Patients & Consumers". Continue reading
Testimony at 2016 FDA public meeting on enhancing the collection, analysis, and availability of demographic subgroup data (3/1/2016) - Dr. Laura Gottschalk testifies to support efforts to improve the safety and effectiveness of drugs and medical devices for ALL patients that are likely to use them. Continue reading
Letter to Senators Alexander and Murray to Prioritize Patient Safety in the Health Legislation (2/8/2016) - February 4, 2016. You are in a unique position to create policies to improve the lives of all Americans through your work on the Senate HELP Committee. We urge you to prioritize patient safety in the health legislation that the committee will mark up on February 9, 2016 and in March. Continue reading
Comments of Members of the Patient, Consumer, and Public Health Coalition on the USPSTF’s draft recommendation statement (1/27/2016) - January 25, 2016 Comments of Members of the Patient, Consumer, and Public Health Coalition on the USPSTF’s draft recommendation statement Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication As members of the Patient, Consumer, and … Continue reading
Comments on Products made from Tobacco Rulemaking (12/30/2015) - We are writing to recommend that the FDA broaden the rule’s focus to be more consistent with the public health intent of the law, which is necessary because of numerous changes in tobacco products that have been introduced since the law passed. Continue reading
Comments on the Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine (12/22/2015) - It is important that the statement concisely describe the benefits and risks associated with the vaccine. But it is equally important that the statement provide all the essential information about the vaccine. Continue reading
Comments on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications” (12/16/2015) - We support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling. Continue reading
Comments on Classification of Medical Cribs (12/11/2015) - December 7, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on Proposed Rule “General Hospital and Personal Use Devices: … Continue reading
Comments on the Establishment of the Patient Engagement Advisory Committee (11/20/2015) - We are concerned about the establishment of a stand-alone Patient Engagement Advisory Committee for medical devices. It is not clear whether this committee will isolate rather than integrate the voices of patients into CDRH decision-making. Continue reading
Comments of members of the Patient, Consumer, and Public Health Coalition on Medical Device Patient Labeling (11/3/2015) - October 30, 2015. We support the emphasis in the workshop on using human factors engineering to ensure they are understandable to the public. We strongly support FDA’s use of objective evidence of usability. Continue reading
Letter to Senators Alexander and Murray supporting efforts to improve the Innovations for Healthier Americans initiative (10/15/2015) - October 2, 2015. One critical area that needs to be examined is healthcare disparities that exist between men and women due to the way medical research is conducted in the United States. We urge the Committee to consider the inclusion of components of the Research for All Act of 2015 within the legislative text of the Innovations initiative. Continue reading
Comments on Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age (8/10/2015) - August 7, 2015. We strongly urge the CPSC to protect the public health by doing all it can to reduce prenatal and childhood exposures to phthalates that could be harmful to human health. Continue reading
Letter to Congressman Cooper supporting Research for All Act of 2015 (5/27/2015) - April 24, 2015. This act would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis. This legislation is needed because most medical research used as the basis of FDA approval decisions focuses on men. Continue reading
Letter to Congresswoman DeGette Expressing Concerns About 21st Century Cures (5/26/2015) - May 19, 2015. As currently written, the FDA provisions of 21st Century Cures violates the basic tenet of medical care–“First, do no harm.” The FDA provisions are more geared toward helping industry than helping patients. Patients deserve an FDA that keeps unsafe and ineffective pharmaceuticals and medical devices (including software) off the market by evaluating their risks and benefits as carefully as possible, in addition to as quickly as possible. Continue reading
Comments on Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates (4/15/2015) - April 15, 2015. We agree with the CPSC that the three permanently banned phthalates—dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), and di(2-ethylhexyl) phthalate (DEHP)—should remain banned. Although we support most of the proposed rule, we have several concerns which we have detailed below. Continue reading
Testimony on Generic Labeling at FDA (3/30/2015) - March 27, 2015 Generic Labeling Testimony at the Food and Drug Administration Docket No. FDA-2013-N-0500 I am Paul Brown and I represent members of the Patient, Consumer, and Public Health Coalition. Last year, 17 members of our Coalition, which includes … Continue reading
Comments on Transfer of Premarket Notification Clearance (3/23/2015) - March 23, 2015 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the draft guidance “Transfer of a Premarket Notification (510(k)) … Continue reading
Comments from Members of the Patient, Consumer, and Public Health Coalition on Innovation for Healthier Americans (3/2/2015) - March 2015 Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the Innovation for Healthier Americans white paper and we look forward to working with the HELP Committee on these public health issues.   … Continue reading
Summary of Comments from Members of the Patient, Consumer, and Public Health Coalition on 21st Century Cures Discussion Draft (3/2/2015) - 21st Century Cures concerns. The American taxpayer is the customer for U.S. public health agencies, not private industry. Continue reading
Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act (2/13/2015) - February 12, 2015 Congresswoman Rosa L. DeLauro 2413 Rayburn HOB Washington, DC 20515 Dear Congresswoman DeLauro: We are writing this letter to express our strong and enthusiastic support for the “Helping Effective Antibiotics to Last” (HEAL) Act. The Centers for … Continue reading
Letter to Minority Leader Reid Thanking Him for Opposing the Repeal of the Medical Device Excise Tax (1/21/2015) - January 14, 2015 The Honorable Harry Reid Minority Leader United States Senate Washington, DC 20510 Dear Minority Leader Reid, As members of the Patient, Consumer, and Public Health coalition and enthusiastic supporters of the Affordable Care Act, we thank you for … Continue reading
Letter to FDA Commissioner Hamburg on New Antibiotic Product (CAZ-AVI) (1/12/2015) - December 19, 2014 Margaret A. Hamburg, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Re: Anti-Infective Drugs Advisory Committee (AIDAC) Meeting on December 5, 2014 Dear Commissioner Hamburg, We are writing as members of … Continue reading
Comments on the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes (1/6/2015) - December 22, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the proposed order on Reclassification of Iontophoresis Devices … Continue reading
Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers (12/16/2014) - December 15, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the proposed order to reclassify External Pacemaker Pulse … Continue reading
Comments on Standardization of Risk Evaluation and Mitigation Strategies (11/25/2014) - November 24, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the draft report Standardization of Risk Evaluation and … Continue reading
Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (10/30/2014) - October 29, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on Draft Guidance for Industry “Internet/Social Media Platforms with … Continue reading
Comments on FDA Safety and Innovation Act Action Plan (10/22/2014) - We strongly support separate analyses of safety and effectiveness for demographic subgroups in clinical trials for drugs and devices. All patients deserve to be assured that the FDA has required that drugs and devices be proven safe and effective on people like them. The data must be methodologically sound and publicly available. Continue reading
Testimony of Dr. Laurén Doamekpor Before the FDA Advisory Panel on Chantix (10/17/2014) - We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses from the Chantix label. To view the entire letter, Continue reading
Comments on De Novo Classification Process (10/15/2014) - October 14, 2014 Division of Docket Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, and Public Health Coalition on Draft Guidance “De Novo Classification Process (Evaluation of … Continue reading
Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (10/15/2014) - October 14, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5600 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, Public Health Coalition on the Draft Guidance “Benefit-Risk Factors to Consider When Determining … Continue reading
Comments on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements (10/7/2014) - October 6, 2014. We strongly urge the FDA to reassess the Submission Type for certain medical devices and continue to require 510(K) clearance due to the high number of MAUDE reports, including numerous deaths from these devices. Devices that can cause fatal adverse events should not be exempt from FDA regulation. Continue reading
Letter to Senator Waxman Expressing Concerns About Speeding Up the Development of New Antibiotic Drugs (ADAPT Act) (9/24/2014) - September 18, 2014 The Honorable Henry Waxman Ranking Member Energy and Commerce Committee United States House of Representatives Washington, DC 20515 Dear Ranking Member Waxman, As members of the Patient, Consumer, and Public Health Coalition, which includes organizations representing patients, … Continue reading
Comments on the Proposed Rule, “Medical Device Classification Procedures” (9/24/2014) - September 22, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852   Comments of members of the Patient, Consumer, and Public Health Coalition on the Proposed Rule, “Medical Device Classification Procedures” Docket … Continue reading
Comments on Draft Guidance for Industry on Internet/Social Media Platforms (9/18/2014) - September 16, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on Draft Guidance for Industry on Internet/Social Media Platforms: … Continue reading
Comments on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices (9/18/2014) - August 25, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, and Public Health Coalition on the Draft Guidance Medical Device Data Systems, Medical … Continue reading
Letter to Senate Committee on Generic Labeling Regulations (9/18/2014) - September 9, 2014 The Honorable Barbara Mikulski Chairwoman Committee on Appropriations United States Senate S128, US Capitol Washington, DC 20510 The Honorable Richard Shelby Ranking Member Committee on Appropriations United States Senate S-146A US Capitol Washington DC 20510 Dear Chairwoman … Continue reading
Comments on Distributing Risk Information for Approved Prescription Drugs and Biological Products (9/18/2014) - August 25, 2014 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 Comments of the Patient, Consumer and Public Health Coalition on the Draft Guidance for Industry on “Distributing Scientific and Medical … Continue reading
Comments on the up-classification of flu detection tests (8/29/2014) - August 20, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, and Public Health Coalition on the Proposed Order Microbiology Devices; Reclassification of Influenza … Continue reading
Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices (8/28/2014) - The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” Continue reading
Comments on proposed rule to allow FDA to regulate all tobacco products (8/8/2014) - Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 August 8, 2014 Comments of members of the Patient, Consumer, and Public Health Coalition On proposed Deeming Rule Deeming Tobacco Products To Be … Continue reading
Coalition strongly supports the FDA’s proposal to upclassify surgical mesh for POP repair and surgical mesh instrumentation (7/31/2014) - July 30, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: [Docket No. FDA-2014-N-0297] Comments on “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for … Continue reading
Comments opposing FDA’s draft guidance on postmarket safety and effectiveness data for high-risk devices (7/31/2014) - July 24, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, and Public Health Coalition on the Draft Guidance “Balancing Premarket and Postmarket Data … Continue reading
Comments in Favor of Draft Recommendation on Screening for Vitamin D Deficiency (7/30/2014) - Comments of Members of the Patient, Consumer, and Public Health Coalition on U.S. Preventive Services Task Force (USPSTF) Draft Recommendation Statement on Screening for Vitamin D Deficiency Members of the Patient, Consumer, and Public Health Coalition commend the U.S. Preventive … Continue reading
Comments Opposing FDA’s Draft Guidance on Speeding Access to High Risk Medical Devices (7/29/2014) - As members of the Patient, Consumer and Public Health Coalition, we do not support the draft guidance for the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” Continue reading
Letter to Congresswoman DeGette Expressing Concerns about 21st Century Cures (7/29/2014) - June 23, 2014 The Honorable Diana DeGette United States House of Representatives Washington, DC 20515 Dear Congresswoman DeGette, As members of the Patient, Consumer, and Public Health Coalition, many of whom have worked with your staff for years, we are writing to … Continue reading
Coalition Concerned that Proposed Regulatory Framework for Health Information Technology will Undermine the FDA’s Mission to Protect the Public Health (7/8/2014) - Coalition Comments of Members of the Patient, Consumer, and Public Health Coalition on the ”Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report” July 7, 2014 Division of Dockets Management (HFA-305)Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, … Continue reading
Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014 (6/11/2014) - To view as a PDF, click here. June 5, 2014 The Honorable Jim Cooper 1536 Longworth HOB Washington, DC 20515 Re: Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014. Dear Congressman Cooper, … Continue reading
Comments from Coalition On the Department of Health and Human Services (HHS) Proposed Rule “Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements” (4/28/2014) - To view as a PDF, click here. April 28, 2014   Comments of Members of the Patient, Consumer, and Public Health Coalition On the Department of Health and Human Services (HHS) Proposed Rule “Voluntary 2015 Edition Electronic Health Record Certification Criteria: … Continue reading
Comments from the Coalition on research entitled “Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements” (4/22/2014) - To view as a PDF, click here.   April 21, 2014 Comments of members of the Patient, Consumer, and Public Health Coalition on research entitled “Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements” Docket No. FDA-2014-N-0168   Members … Continue reading
Letter to FDA Commissioner Margaret Hamburg Re: Microbiology Medical Devices Panel on Cobas HPV Test Premarket Approval Application (4/14/2014) - April 11, 2014 Margaret A. Hamburg, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Re: Microbiology Medical Devices Panel on Cobas HPV Test Premarket Approval Application Dear Commissioner Hamburg, We are writing as members … Continue reading
Letter to Janet Woodcock Director of Center for Drug Evaluation and Research FDA on Flibanserin (4/8/2014) - To view as a PDF, click here. April 8, 2014 Janet Woodcock, MD Director Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Re: Flibanserin Dear Dr. Woodcock, As members of the … Continue reading
Comments on Proposed Order That Splits Cardiovascular Device into Two Classifications (4/8/2014) - To view as PDF, click here. April 7, 2014   Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852     Comments of Members of the Patient, Consumer, and Public Health Coalition on … Continue reading
Letter to the Accredited Standards Committee X12 Chair Margaret Weiker in Strong Support for Updated Standards for the New Unique Device Identifier (UDI) System (3/31/2014) - To view as PDF, click here. March 28, 2014 Margaret Weiker Chair, X12N The Accredited Standards Committee X12 8300 Greensboro Drive Suite800 McLean,VA 22102   RE: Transmission of the unique device identifier in claims. Dear Ms. Margaret Weiker, As members of … Continue reading
Letter to Senator Feinstein in Strong Support S. 1256, the Preventing Antibiotic Resistance Act (3/26/2014) - To view as PDF, click here. March 25, 2014 The Honorable Dianne Feinstein 331 Hart Senate Office Building U.S. Senate Washington, DC 20510   Dear Senator Feinstein, As members of the Patient, Consumer, and Public Health Coalition, we strongly support … Continue reading
Letter to Congresswoman DeLauro Thanking Her for Her Dedication to Patients and Consumers (3/26/2014) - To view as a PDF, click here. February 6, 2014 The Honorable Rosa DeLauro 2413 Rayburn House Office Building Washington, DC 20515   Dear Congresswoman DeLauro, We are writing to thank you for your dedication to patients and consumers through your … Continue reading
Letter to Ranking Member Waxmen of Opposition to H.R. 3303, the SOFTWARE Act of 2013 (3/26/2014) - To view as PDF, click here. February 14, 2014 The Honorable Henry A. Waxman Ranking Member Energy & Commerce Committee Dear Ranking Member Waxman, As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose H.R. 3303, the SOFTWARE … Continue reading
Letter to Chairman Harkin on Opposition on the Preventing Regulatory Overrreach To Enhance Care Technology (PROTECT) Act of 2014 (3/26/2014) - To view as PDF, click here. February 14, 2014   The Honorable Tom Harkin, Chairman HELP Committee United States Senate Washington, DC 20510   Dear Chairman Harkin, As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose … Continue reading
Letter to Representative Slaughter in strong support of H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act (3/25/2014) - To view as PDF, click here. March 21, 2014   The Honorable Louise Slaughter U.S. House of Representatives 2469 Rayburn House Office Building Washington, DC 20515   Dear Congresswoman Slaughter, As members of the Patient, Consumer, and Public Health Coalition, we … Continue reading
Coalition Concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 (2/24/2014) - As members of the Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, we are writing to express our concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Continue reading
Letter of Opposition for the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 (2/18/2014) - As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014. Continue reading
Comments on the Food and Drug Administration’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (2/10/2014) - As members of the Patient, Consumer, and Public Health Coalition, we are pleased to have the opportunity to strongly support the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Continue reading
Comments on the Food and Drug Administration’s Draft Guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (2/6/2014) - As members of the Patient, Consumer, and Public Health Coalition, we conditionally support the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding. Continue reading
Comments on the Food and Drug Administration’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (2/6/2014) - February 5, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5600 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, Public Health Coalition on the Food and Drug Administration’s Proposed Rule “Supplemental Applications … Continue reading
Letter to House Leaders in Opposition to H.J. Res 77 (10/8/2013) - We are writing as public health, patient, consumer, and scientific nonprofit organizations to oppose H.J. Res 77 and any other efforts to single out the Food and Drug Administration for funding.  Continue reading
Members of the Patient, Consumer, and Public Health Coalition support the Patient Protection and Affordable Care Act (ACA) and oppose efforts to repeal the 2.3% excise tax on medical devices (9/26/2013) - September 25, 2013 The Honorable Harry Reid Majority Leader United States Senate Washington, DC 20510 Dear Majority Leader Reid, As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Patient Protection and Affordable Care Act (ACA) … Continue reading
Members of the Patient, Consumer, and Public Health Coalition strongly support FDA’s ban on the imports of Ranbaxy medical products (9/26/2013) - September 26, 2013 Margaret A. Hamburg, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Re: Members of the Patient, Consumer, and Public Health Coalition strongly support FDA’s ban on the imports of Ranbaxy medical … Continue reading
Comments on Proposed Order “Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses” (9/18/2013) - September 17, 2013 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 Comments of Members of the Patient, Consumer, and Public Health Coalition on Proposed Order “CardiovascularDevices; Reclassification of Intra-Aortic Balloon and … Continue reading
Comments on Proposed Order “Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs” (9/11/2013) - September 10, 2013 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852   Comments of nonprofit patient, consumer, and public health organizations on Proposed Order Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs” … Continue reading
Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices (9/10/2013) - January 17, 2012 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of the Patient, Consumer, and Public Health Coalition on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator … Continue reading
Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina and Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses (8/20/2013) - August 19, 2013 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 Comments of the Patient, Consumer, and Public Health Coalition on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable … Continue reading
Comments on Proposed Order “General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products” (8/8/2013) - Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 August 7, 2013 Comments of the Patient, Consumer, and Public Health Coalition on Proposed Order “General and Plastic Surgery Devices: Reclassification of Ultraviolet … Continue reading
Comments Re: Review of final rule for FDA’s Unique Device Identification System (7/3/2013) - July 3, 2013 The Honorable Sylvia Mathews Burwell Director Office of Management and Budget 243 Old Executive Office Building Washington, DC 20503   Re: Review of final rule for FDA’s Unique Device Identification System   Dear Director Mathews Burwell, As … Continue reading
Comments on Proposed Order “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System” (6/25/2013) - As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). However, we oppose the FDA exercising an enforcement discretion that would allow 510(k) cleared AEDs to remain on the market for 15 months after FDA issues a final order requiring a PMA for these devices. Continue reading
Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act (4/16/2013) - Like you, members of the Patient, Consumer, and Public Health Coalition are very supportive of the Patient Protection and Affordable Care Act (ACA). We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8 ) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment. Continue reading
Letter to Congresswoman Rosa DeLauro in Support of the “Healthy Families Act” (3/20/2013) - We strongly support the “Healthy Families Act.” Thank you for sponsoring this important legislation, which would create a national standard for paid sick days. Continue reading
Letter to Senator Tom Harkin in Support of the “Healthy Families Act” (3/20/2013) - March 12, 2013 The Honorable Tom Harkin, Chairman HELP Committee United States Senate Washington, DC 20510 Dear Chairman Harkin, We strongly support the “Healthy Families Act.” Thank you for sponsoring this important legislation, which would create a national standard for … Continue reading
Comments to the FDA on “Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need” (2/5/2013) - January 30, 2013 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, MD 20852 Comments of the Patient and Consumer Coalition “Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical … Continue reading
Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose (1/17/2013) - Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of the Patient, Consumer, and Public Health Coalition on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; … Continue reading
Comments of Patient and Consumer Coalition On proposed rule “Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses” [Docket No. FDA-2012-N-0378] (1/17/2013) - Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland2 0852   October 4, 2012 Comments of Patient and Consumer Coalition On proposed rule “Requirement for Premarket Approval for Shortwave Diathermy for All Other … Continue reading
Letter to HELP Committee on Track and Trace Legislation (1/10/2013) - November 7, 2012 Chairman Harkin and Ranking Member Enzi of the HELP Committee, Chairman Upton and Ranking Member Waxman of the Energy and Commerce Committee, Senators Grassley, Feinstein, Alexander, Burr, Whitehouse, and Bennet, and Representatives Dingell, Pallone, Bilbray, and Matheson: … Continue reading
Letter to CMS urging the release of the Sunshine Act final regulations (1/10/2013) - November 15, 2012 Marilyn Tavenner Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Humans Services Room 445-G Hubert H. Humphrey Building 200 Independence Ave, SW Washington, DC 20201 Dear Ms. Tavenner: As members of the Patient, … Continue reading
Letter to Congressman Edward J. Markey on the VALID Compounding Act of 2012 (1/10/2013) - October 31, 2012 The Honorable Edward J. Markey Energy and Commerce Committee U.S. House of Representatives 2108 Rayburn Washington, DC  20515 Dear Congressman Markey, As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment … Continue reading
Comments Re: FDA’s Recent HELP Committee testimony on pharmacy compounding (1/10/2013) - November 30, 2012 Chairman Tom Harkin                                                Ranking Member Mike Enzi 731 Hart Senate Office Building                                379A Senate Russell Office Building Washington, DC 20510                                              Washington, DC 20510 Comments from Members of the Patient, Consumer, and Public Health Coalition Re: FDA’s … Continue reading
Comments Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding” (1/10/2013) - Members of the Patient, Consumer, and Public Health Coalition welcome the opportunity to provide our views regarding pharmacy compounding.  Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.  Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. Continue reading
Letter to U.S. Senators in opposition of efforts to delay or repeal excise tax on medical devices (1/2/2013) - December 19, 2012 Note: The Patient, Consumer, and Public Health Coalition sent this letter to 15 Democratic Senators and 2 Democratic Senators-Elect who had signed a letter urging Majority Leader Harry Reid to delay the implementation of the excise tax … Continue reading
Comments on the Proposed Rule, “Unique Device Identification System” (11/7/2012) - November 7, 2012 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: [Docket No. FDA-2011-N-0090] Comments on the Proposed Rule, “Unique Device Identification System” To whom it may concern, As members … Continue reading
Comments to the FDA Regarding Representative Edward J. Markey’s filing of a Food Additive Petition (10/2/2012) - September 17, 2012 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of Members of the Patient, Consumer, and Public Health Coalition Regarding Representative Edward J. Markey’s filing of a Food Additive Petition [Docket No. FDA-2102-F-0728] … Continue reading
Comments to the U.S. Consumer Product Safety Commission on Children’s Toys and Child Care Articles Containing Phthalates (10/2/2012) - October 1, 2012 Office of the Secretary U.S. Consumer Product Safety Commission 4330 East West Highway Bethesda, MD 20814   Comments of the Patient, Consumer and Public Health Coalition on “Children’s Toys and Child Care Articles Containing Phthalates Proposed Guidance … Continue reading
Letter to Maryland Department of Health and Mental Hygiene opposing the use of ASTM International Standard as a safety standard for baby bumper pads (10/2/2012) - September 28, 2012 Michele Phinney, Director Office of Regulation and Policy Coordination Department of Health and Mental Hygiene 201 W. Preston St. Room 512 Baltimore, MD 21201 Re: Request for Public Comment: ASTM International Standard Consumer Safety Performance Specification for … Continue reading
Letter to Department of Health and Mental Hygiene in Support of Ban on Crib Bumpers (7/20/2012) - As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong support for Maryland’s proposed regulation to ban baby bumper pads in cribs. We agree with the Department of Health and Mental Hygiene (DHMH) that “the pads pose a risk of suffocation, strangulations, and death." Continue reading
Comments to the Centers for Medicare and Medicaid Services on Transparency Reports and Reporting of Physician Ownership or Investment Interests (6/19/2012) - As members of the Patient, Consumer, and Public Health Coalition, we are writing to comment on the Centers for Medicare & Medicaid Services' (CMS) proposed rule on transparency reports and the reporting of physician ownership or investments. We strongly support the goals of the Physician Payments Sunshine Act, codified as Section 1128G of the Social Security Act. Continue reading
Comments Regarding the Medical Device User Fee Act (6/19/2012) - The coalition is not enthusiastic about user fees, but in today’s budgetary climate, they are necessary, especially since the FDA has been under-funded for years. In particular, the Center for Devices and Radiological Health (CDRH) has struggled to manage an expanded demand for more complex devices with inadequate appropriations. The coalition will continue to advocate with Congress for increased funding for the FDA to ensure the agency has the resources it needs to carry out its mission of protecting and promoting the public health. Continue reading
Letter to the House of Representatives Energy and Commerce Committee and Health Subcommittee about the Generating Antibiotic Incentives Now (GAIN) Bill (6/19/2012) - As members of the nonprofit Patient, Consumer, and Public Health Coalition, we understand the need for new antibiotics. The Generating Antibiotic Incentives Now (GAIN) bill focuses on providing incentives to pharmaceutical companies, which is important. However, some antibiotics are much more important than others. For example, approximately 20% of antibiotic prescriptions are used for sinus infections, and new research indicates they are completely ineffective because placebo works just as well. The bill as currently drafted does not focus on the areas of greatest public health need. Unfortunately, as currently written, this bill could have the unintended consequences of increasing antibiotic resistance and increasing health care costs while not addressing the need for new antibiotics to save the lives of patients when other antibiotics fail. Continue reading
Letter to Dr. Margaret Hamburg on the De Novo Process and High Risk Medical Devices (6/19/2012) - We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the use of the de novo process for high-risk medical devices. We have previously expressed our strong concerns about the low standards of the 510(k) premarket clearance process for medical devices. Although intended for low- and moderate-risk devices, too many devices that are high-risk are cleared through the 510(k) process and later found to cause life-threatening adverse events. Continue reading
Letter to the House Committee on Energy and Commerce in Support for the Safety of Untested and New Devices (SOUND Devices) Act of 2012 (6/19/2012) - As members of the Patient, Consumer, and Public Health Coalition, which includes nonprofit organizations and individuals that represent patients, consumers, physicians, scientists, and researchers, we want to express our strong support for H.R. 3847, the Safety of Untested and New Devices (SOUND Devices) Act of 2012. This legislation will protect the public from avoidable harms caused by unsafe devices that should never have been cleared for sale in the first place. It will also help to ensure that decisions on device safety are based on more reliable information. Continue reading
Letter to the FDA and Commissioner Hamburg in Support of the Filing of Premarket Approval for the Implantable Pacemaker Pulse Generator (6/19/2012) - The listed patient, consumer, and public health organizations below strongly support the FDA’s proposal to require the filing of a premarket approval application (PMA) for the implantable pacemaker pulse generator, a class III pre-amendments device. Continue reading
Comments of Members of the Patient, Consumer, and Public Health Coalition FDA’s Center for Devices and Radiological Health 510(k) Clearance Process: Recommendations Proposed in Institute of Medicine (6/19/2012) - Members of the Patient, Consumer, and Public Health Coalition support the Institute of Medicine’s (IOM) efforts to strengthen the 510(k) clearance process for medical devices, but believe that the concerns expressed by the IOM regarding the lack of proof of safety and efficacy can be addressed by substantially improving 510(k) criteria, policies, and implementation. We strongly encourage CDRH to incorporate the concerns of the IOM report into substantial efforts to improve the 510(k) process, and to better ensure the safety and effectiveness of implanted medical devices by requiring that they all be reviewed through the PMA process instead. Continue reading
Letter to the Center for Devices and Radiological Health on the Implementation of the Unique Device Identification (UDI) System (6/19/2012) - The Patient, Consumer, and Public Health Coalition strongly supports the implementation of the Unique Device Identification (UDI) system, which was part of the Center for Devices and Radiological Health’s (CDRH) 510(k) and Science Report Recommendations issued earlier this year. Continue reading
Letter to the Food and Drug Administration on Stakeholder Response to FDA and Industry MDUFA III Proposals (6/19/2012) - In this letter to the Food and Drug Administration, the coalition provided a stakeholder response to industry MDUFA III proposals. They recommended a five year renewal with stronger consumer protections, including a unique ID system, improvements to the MAUDE database and a stronger FDA infrastructure. Continue reading
Letter to Secretary Sebelius on Proposed Recommendations for PDUFA V (6/19/2012) - The coalition's main concern is that most of the recommendations are aimed at industry perceived barriers to new drug approvals, rather than concerns about protecting and promoting the health of patients and consumers by ensuring timely access to safe and effective drugs. They recognize that some of the recommendations have the potential to benefit patients by speeding up the approval process and improving the chances that drugs will be available when they are needed. There is too little emphasis, however, on performance goals aimed at improving the safety and efficacy of drugs. The focus must be on a process that provides timely access to safe and effective drugs while reducing exposure to harmful drugs that pose undue risks. Drugs must only be approved with adequate evidence to support their safety and effectiveness and a robust post-market surveillance system must be in place to ensure that drugs found to be dangerous are removed from the market as quickly as possible. Continue reading

Coalition Members

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American Medical Student Association

The American Medical Student Association (AMSA) is the oldest and largest independent association of physicians-in-training in the United States. It is a student-governed, national organization representing 35,000 future physicians, whose concern is preserving the integrity of patient care. AMSA strongly supports access to quality health care, with treatments based on meaningful clinical trial data measuring outcomes that patients care about, such as improved health and quality of life.

American Medical Women’s Association

AMWA empowers women to lead in improving health for all within a model that reflects the unique perspective of women. Membership is comprised of physicians, residents, medical students, and health care professionals.  The oldest multispecialty organization dedicated to advancing women in medicine and improving women’s health, AMWA functions at the local, national, and international level.

Annie Appleseed Project

Annie Appleseed Project provides information on cancer risk reduction, recurrence reduction, ways to reduce toxicities from conventional treatment (Integrative oncology) and alternative medicine from the patient perspective.

ASHES

ASHES (Advocating Safety in Healthcare E-Sisters) educates and informs women and men about the importance of researching any prescription drug or medical device, and advocates for help to those who have been harmed and to improve the U.S. drug and device approval processes.  The nonprofit organization grew from an informal support and advocacy group for women harmed by Essure, a permanent birth control device.

Association for Medical Ethics (AME)

The Association for Medical Ethics (AME) consists of physicians from every specialty of medicine. The purpose of the Association is to promote patient care and good, evidence-based medicine.

Breast Cancer Action

Breast Cancer Action (BCAction) is a national, feminist grassroots education and advocacy organization working to end the breast cancer epidemic, which is a public health crisis and a social justice issue. BCAction advocates for systemic change and provides information to anyone who needs it via a free information and referral service, webinars, and more.

Breast Cancer Consortium

The Breast Cancer Consortium (BCC) is an independent, international nonprofit organization aimed at deepening understanding of the social, cultural, and system-wide factors affecting breast cancer. BCC promotes research and development in the social sciences and humanities and uses evidence-based models to inform and improve the breast cancer paradigm.

Cancer Prevention and Treatment Fund

Helps patients, policy makers, and health professionals prevent cancer and improve treatments for cancer through the use of evidence-based policies, programs, and treatments. It is the major program of the National Center for Health Research.

Center for Medical Consumers

Advocates on behalf of public access to scientifically accurate, complete information about benefits and risks in order to make informed decisions about their medical and health care.

Connecticut Center for Patient Safety

An independent nonprofit organization that works to promote patient safety; improve the quality of health care, and protect the rights of patients.

Consumer Federation of America

Consumer Federation of America is an association of nearly 300 nonprofit consumer organizations that was established in 1968 to advance the consumer interest through research, advocacy and education.

Consumers Union

An independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU publishes the popular magazine Consumer Reports, and CU’s staff works with the organization’s more than 600,000 online activists to protect consumer interests.

DES Action USA

DES Action USA identifies, educates, empowers and advocates for DES-exposed families. DES was the first synthetic estrogen and first endocrine disruptor. It was given to millions of pregnant women in the 1950s, 60s and 70s. It caused increased breast cancer rates for the mothers. Prenatal exposure is associated with reproductive cancers, infertility and structural changes in the reproductive tract for both DES daughters and sons. Research continues to find ongoing damage to the second generation and now is finding damage to the grandchildren.

Government Accountability Project

Promotes corporate and government accountability by protecting whistleblowers, advancing occupational free speech, and empowering citizen activists.

Institute for Ethics and Emerging Technology

The IEET’s mission is to be a center for voices arguing for a responsible, constructive, ethical approach to the most powerful emerging technologies. We believe that technological progress can be a catalyst for positive human development so long as we ensure that technologies are safe and equitably distributed. We call this a “technoprogressive” orientation

Jacob’s Institute of Women’s Health

MedShadow.org

MedShadow.org is a social media based nonprofit educating the public that all medicines have side effects and many have long-term effects. Most drugs have not been studied long enough to know what all the side effects might be. We gather information on what is known so people can balance the benefits against the risks in order to work with their doctors to determine the best health care decisions for themselves. MedShadow does not accept pharmaceutical or health insurance support.

MISSD

MISSD is a unique non-profit organization dedicated to honoring the memory of Stewart Dolin and other victims of medication-induced suicide and akathisia by raising awareness and educating the public about the dangers of akathisia.  Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

National Center for Health Research

A nonprofit research and education organization that is dedicated to improving the health and safety of adults and children by using research findings to improve policies, programs, and evidence-based medical treatments.

National Consumers League

Protects and promotes social and economic justice for consumers. NCL provides government, businesses, and other organizations with the consumer’s perspective on concerns including food safety and medication information.

National Physicians Alliance

The National Physicians Alliance creates research and education programs that promote health and foster active engagement of physicians with their communities to achieve high quality, affordable health care for all.  The NPA offers a professional home to physicians across medical specialties who share a commitment to professional integrity and health justice. Believing that the best way to win public trust is to earn it, the organization accepts no funding from pharmaceutical or medical device companies.

National Women’s Health Network

A nonprofit advocacy organization that works to improve the health of all women by developing and promoting a critical analysis of health issues in order to affect policy and support consumer decision-making. The Network aspires to a health care system that reflects the needs of diverse women.

Our Bodies Ourselves

Our Bodies Ourselves (OBOS) is a nonprofit, public interest women’s health education, advocacy, and consulting organization that provides accessible, research-based information about women’s health and sexuality. OBOS advances health and human rights within a framework of values shaped by women’s voices and a commitment to self-determination and equality.

Reproductive Health Technologies Project

The Society for Patient Centered Orthopedics

The Society for Patient Centered Orthopedics is a group of orthopedic surgeons dedicated to placing patient interests first and foremost within the American healthcare system.  We understand that the concerns and problems of our patients are the raison d’etre of our profession and must take precedence over our professional desires.   We advocate for policies that improve the patient experience and increase the quality and value of American healthcare.  Our goal is a system that is patient centered and provides care that is both effective and meaningful to patients.

The TMJ Association

A patient advocacy organization whose mission is to improve the quality of healthcare and lives of everyone affected by temporomandibular disorders (TMJD).

Union of Concerned Scientists

Now an alliance of 400,000 citizens and scientists, the Union of Concerned Scientists is the leading science-based nonprofit working for a healthy environment and a safer world. UCS combines independent scientific research and citizen action to develop innovative, practical solutions and to secure responsible changes in government policy, corporate practices, and consumer choices.

US PIRG

Washington Advocates for Patient Safety (WAPS)

Washington Advocates for Patient Safety is a non-profit, grass-root organization. Our goals are to be the voice of patients, to work to eliminate medical errors and harm, and to save more lives. Our mission is to promote accountability, quality, safety, and responsibility in patient care. Our goals are to advocate for patient-centered care; quality healthcare and medication safety; prevention of Hospital-associated infections; medical device safety; patient’s rights to be informed of all treatment risks and choices; better communications between patients and medical professionals; health care transparency and accountability.

WomenHeart

The National Coalition for Women with Heart Disease is the only national organization dedicated to promoting women’s heart health through advocacy, education and patient support. The coalition promotes prevention and early detection, accurate diagnosis and proper treatment for all women with heart disease, advocating for equal access to quality care.

WoodyMatters

A nonprofit patient advocacy organization focused on saving patients from adverse effects of unsafe medical products.