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Coalition Letter to FDA and CDRH regarding MDUFA Reauthorization

As key stakeholders, we strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review, in order to achieve the FDA’s mission to protect patients from unsafe products and enhance public health.

Public Comments to CMS on Aduhelm for the Treatment of Alzheimer’s Disease

We strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population. We agree with CMS that this will enable patients and family members to make informed decisions based on unbiased information pertaining to the known risks and as yet unproven benefits. 

Public Comments on FDA’s Generic Drugs Commitment Letter

We believe that the proposed recommendations must do more to ensure that generic drugs are providing an equally beneficial treatment for patients and consumers. We appreciate the efforts of the agency to work toward those ends, but as long as patients and consumers are excluded from the GDUFA negotiations, the concerns and priorities of these principal stakeholders will also be excluded.

Comments of Members of the Patient, Consumer and Public Health Coalition on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

We strongly oppose allowing companies to promote medical device products for off-label uses. There are not adequate safeguards to allow such promotion to be limited to only scientifically sound, complete and unbiased data. While some patients are helped by off-label uses, many also are harmed by the same poorly-regulated practices.

Coalition Comments on FDA Draft Guidance for Generic Abuse-Deterrent Opioids

We applaud the FDA for providing guidance to industry to advance the regulatory science behind abuse-deterrent oral opioid formulations. 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”.

Coalition’s Comments on FDA’s Efforts to Improve Diversity and Analyses in Clinical Trials

The FDA needs to make it clear to companies that if they want their drugs approved for women and men, whites and people of color, and adults of all ages (and especially Medicare beneficiaries), they need to study sufficient numbers of those patients in subgroup analyses to make sure the drugs are safe and effective for them in the short-term and long-term.

Coalition’s Comments on FDA’s Direct-to-Consumer Advertising Survey

To truly protect consumers, and reduce unnecessary healthcare costs, Congress and the FDA need to do more than survey the public about DTC ads. They need to propose laws and rules to limit the persuasive power and unbalanced information provided in DTC ads, especially for drugs that have not been tested for long-term safety on a large population.