Prescription and over-the-counter drugs can be life-saving or harmful. Our goal is to improve the safety and effectiveness of drugs sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks.
The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
February 27, 2023: The Coalition urges Congress to support the decision by the Centers for
Medicare and Medicaid Services (CMS) to limit the coverage of newly approved Alzheimer’s
drugs until the treatments have been shown to have a meaningful, clinical benefit that outweighs
the risks for the Medicare population.
We applaud your National Coverage Determination limited coverage of this class of drugs solely to patients participating in clinical trials following the approval of aducanamab (Aduhelm) by the FDA. The FDA approved Biogen and Eisai’s lecanemab today, and we urge you to hold firm to your decision to prioritize patient safety and the scientific credibility of CMS’s coverage decisions.
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.
Patients deserve access to smoking cessation treatments, but they also deserve warnings about the risks. There remains considerable credible evidence that some patients are severely harmed by Chantix and Zyban, and those patients’ lives depend on warnings about the risks, so they will recognize that sudden suicidal, paranoid, or violent thoughts are side effects of the drugs.
In November 2013, the Food and Drug Administration (FDA) proposed to revise its regulations to allow generic drug manufacturers to initiate safety updates to their products’ labeling.[1] We strongly support the FDA’s proposal.
We support providing FDA with additional resources through the implementation of OTC user fees, so the agency can fulfill its mission of protecting the public from dangerous and ineffective OTC products. Additional funding will help FDA to finalize the remaining OTC monographs, and allow patients and consumers to have confidence in the OTC products they use every day.
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”.
