Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA

Sue Sutter, Pink Sheet, June 13, 2024

Many consumer representative positions on advisory committees either are vacant or filled by individuals with ties to academia, industry or patient groups, rather than true consumer or public interest organizations, several speakers said during a 13 June FDA listening session on optimizing the advisory committee process.

“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,” said Sophia Phillips, a representative of the Patient, Consumer and Public Health Coalition. The listening session coincided with same-day publication of a Federal Register notice in which the FDA requested nominations for consumer representatives to serve on advisory committees.

The notice lists five eligibility criteria for consumer representatives:

• Demonstrate an affiliation with and/or active participation in consumer or community-based organizations

• Be able to analyze technical data

• Understand research design

• Discuss benefits and risks

• Evaluate the safety and efficacy of products under review.

Phillips asserted that very few consumer representatives meet the standards for active participation in a consumer organization and ability to analyze scientific data and critique research design. “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,” she said.

Public comments were requested on service on the panels as a special government employee, public perception and understanding of adcomms, and adcomm composition, including whether the agency can better incorporate the consumer or patient voice into committee composition.

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MedShadow and DES Action are members of the Patient, Consumer and Public Health Coalition, which consists of more than 30 patient, consumer, and public health organizations in the US. The coalition previously has raised concerns about the adcomm process and requested that center directors and other agency officials refrain from making comments at meetings that can be interpreted as encouraging panelists to vote in a particular way. (Also see “US FDA Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says” – Pink Sheet, 20 Jul, 2023. )

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