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Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting

October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.

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Coalition letter to CMS on Lecanemab approval and maintaining their coverage decision

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.

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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.

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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. 

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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.

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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.

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Comments on FDA’s Proposed Reclassification of ECT Devices for Treating Severe Major Depressive Episodes

ECT devices are potentially high-risk devices and should remain as class III and should be subject to PMA review for all indications. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.

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Coalition’s Comment the Black Box Warning and Patient Decision Checklist for Essure Birth Control System

We appreciate the efforts of the FDA to improve the information available to women and physicians considering the Essure System for Permanent Birth Control, through a “Boxed Warning” (black box warning) and a “Patient Decision Checklist” as part of the product labeling.  However, we believe that the draft guidance is not sufficient.

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