Policy Positions

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 Opposing the “Right to Try” Law (8/1/2017) - July 31, 2017 Dear Senator: The time is at hand for a momentous decision in the Senate which could greatly affect how patients get access to experimental drugs.  We are writing as members of the Patient, Consumer, and Public Health … Continue reading
Letter of Opposition to Trickett Wendler Right to Try Act of 2017 (S. 204) (2/27/2017) - We urge you to strongly oppose S. 204 because it would undermine the successful program already in place to enable patients to have access to experimental drugs for free or at cost. Continue reading
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
Coalition Comment on Conflicts of Interest (11/26/2016) - Comments of members of the Patient, Consumer, and Public Health Coalition on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee … Continue reading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