We are writing to express our views as consumers, physicians, scientists, and public health experts regarding the health care legislation scheduled to be marked up on March 9, 2016. We want all Americans to have the best possible medical treatments, and that includes making sure that the safety and effectiveness of medical products are not compromised in the process.
Letter to HELP Committee Re: Innovation Bills Read More »
The Patient, Consumer, and Public Health Coalition held a Senate briefing titled “Innovation for Healthier Americans: The Impact of Proposed Health Bills on Patients & Consumers”. This article covers the details of the briefing.
Innovation for Healthier Americans: Materials from our Senate briefing Read More »
We support efforts to improve the safety and effectiveness of drugs and medical devices for ALL patients that are likely to use them. Women, people of color, and patients over the age of 65 have often been under-represented in clinical trials. Just as that was improving in recent years, efforts to speed drug approval have resulted in smaller clinical trials. So, the number of patients in those groups are again shrinking, making it impossible to do meaningful analysis of safety or effectiveness.
We strongly support the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are articulated in the draft guidance. Americans are using sunscreens more frequently and on a more long-term basis than ever before. Our safety and efficacy standards must reflect that Americans of all ages rely on these products to protect them from skin cancer.
Coalition Strongly Supports FDA’s Proposal to Regulate Over-the-Counter Sunscreens Read More »
We are writing to respond to the FDA’s draft guidance for comments on appearances of conflicts of interest. In our view, there are troublesome inconsistencies in the way that the FDA considers financial conflicts of interest and how they consider appearances of conflicts of interest. Moreover, there are also troubling inconsistencies in how the FDA perceives such appearances for public health and consumer advocates and how they are considered for clinicians.
Coalition Comment on Conflicts of Interest Read More »
The Patient, Consumer, and Public Health Coalition strongly supports efforts to improve the safety and effectiveness of drugs and medical devices. We urge Senator Alexander and Senator Murray to prioritize patient safety in the health legislation that the committee will mark up on February 9, 2016 and in March.
We are submitting these comments to express our strong concerns about the United States Preventive Services Task Force’s (USPSTF) draft recommendation statement. We strongly disagree with USPSTF’s two recommendations regarding adults aged 40 to 75.
We 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.
Comments on Products made from Tobacco Rulemaking Read More »
We have reviewed the vaccine information statement and we have suggested revisions for the wording and content of the Vaccine Information Statement. 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.
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.
