June 13, 2024
Hello, my name is Sophia Phillips and I’m speaking on behalf of the Patient, Consumer, and Public Health Coalition. We are an informal coalition of organizations representing the interests of patients, consumers, health-care professionals, scientists, public health experts, and advocates.
We wish to express our comments regarding topic 1: the Composition of Advisory Committees.
To begin, we have concerns with the patients, health professionals, and industry-affiliated individuals who are often miscategorized as Consumer Representatives on FDA Advisory Committees, as they do not represent consumers’ priorities or perspectives.
According to the FDA, candidates for this position are intended to meet the following criteria:
1. Ability to analyze scientific data and critique research design.
2. Affiliation with active participation in independent consumer or community-based organizations, or a history of advocating for the public interest.
Unfortunately, very few Consumer Representatives meet these standards. Many lack the ability to analyze scientific data and critique research design, and many candidates selected would better fill the position of a patient rep, or industry rep, as they possess strong ties to industry, or the very products they are reviewing.
The current standards for conflicts of interests are inadequate, and as written, can have significant implications on meeting outcomes. As an example, earlier this year, the FDA convened an Advisory Committee meeting to assess a cardiac device made by Abbott, but they did not disclose that most committee members had received payments from the company or conducted research funded by Abbott — yet this information was readily available in a federal database.
We urge the FDA to review more closely all appointments, establish clear and consistently applied guidelines regarding conflicts of interest, and provide appropriate training to appointees that highlights the public health mission of the FDA and the scientific standards required by law.