Coalition Letter to FDA regarding consumer representatives in Advisory Committees

Dear Commissioner Califf, 

We write today as member organizations of the Patient, Consumer, and Public Health Coalition to express our concerns regarding patients, health professionals, and industry-affiliated individuals who are erroneously categorized as Consumer Representatives on FDA Advisory Committees but who do not represent consumers’ priorities or perspectives. Two recent examples are below.

On September 12, 2023, the NDAC Consumer Representative seat was occupied by Emma D’Agostino. As the lead medical writer for BOLDSCIENCE, a company that identifies itself as serving pharmaceutical companies by writing materials that provide a compelling voice on their behalf, Ms. D’Agostino does not bring the consumer perspective to the meeting. Meanwhile, industry has more than sufficient representation on the committee already with an Industry Rep and the presence of the Consumer Healthcare Products Association.

During the September 27, 2023, meeting of the FDA Advisory Committee for an ALS drug, all the physicians and researchers on the panel as well as the ALS patient serving as the Patient Representative, voted against the drug, because it had no credible scientific evidence that it worked and had a statistically significantly higher death rate than placebo. The only vote in favor was the Consumer Rep, who justified her vote because of the large number of written comments and 15 OPH speakers urging FDA to approve the drug. Here’s how the Pink Sheet described the Consumer Rep’s rationale:

“The lone favorable vote came from the panel’s consumer representative, Kathleen O’Sullivan Fortin, founder of ALD Connect, who said she factored into her decision “data that no one else considers as real data,” meaning patients’ testimony about their positive experiences with NurOwn. “I think there’s no bigger risk than imminent certain death from ALS, and these are unique and desperate circumstances that would require us to exercise flexibility,” she said”.

Patients’ experiences can be very helpful in understanding why treatments are needed or how they can be helpful, but the Consumer Representative clearly did not understand the importance of considering the data for any drug that FDA was considering, or the potential bias introduced by the conflicts of interest of people paid to advocate for a drug approval. She categorized the patients who testified as evidence, but she implied that she was even more influenced by the “thousands” of public comments that had been submitted to FDA urging approval of the drug. She apparently did not understand that the statistical significance level of the primary and secondary endpoints ranged from .45 to .69, which meant that there was between a 45% and 69% chance that any difference between the drug and placebo happened by chance, not due to the benefits of the treatment. Since a .10 probability level is considered a marginal trend, and a .05 level or less is considered significant only when controlling for multiple comparisons, it wasn’t even close, and was less than a coin toss for most comparisons.  Meanwhile, patients taking the drug were more than 3 times more likely to die, which was statistically significant and which the Consumer Rep failed to mention when she justified her support for NurOwn as a way to help patients avoid certain death.

Neither of these Consumer Representatives represented the consumer perspective. The appointment of a professional writer who is paid by companies to persuade patients to buy their products is a clear conflict of interest. Her appointment does not comply with the requirements, by letter or in spirit, of a Consumer Representative. Since the ALS Advisory Committee was specifically asked to focus on the scientific evidence, that Consumer Representative obviously failed in her role. Patient Representatives should focus on the risks and benefits of treatments for patients, but Consumer Reps must have a broader perspective that focuses more on what is good for the public, not the needs of specific patients. The FDA has a clear duty to include on all Advisory Committees a Consumer Rep who understandsthe role of the FDA, the importance of meeting scientific standards, and the ability to provide an unbiased and informed, perspective.

Several members of our Coalition currently serve as Consumer Representatives at FDA Advisory Committees. In addition, several of us have encouraged colleagues who are active in consumer organizations and knowledgeable about clinical trials and statistics to apply for Consumer Representative positions on FDA Advisory Committees. Many of these individuals have waited years to hear from the FDA regarding their applications, but never received a response. Meanwhile, FDA continues to appoint Consumer Representatives who are not representing consumers, but are instead patients and health professionals whose perspectives are already well represented by other Advisory Committee members. 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. This is crucial for all Advisory Committee members, but often especially lacking for Consumer Representatives. 


American Medical Student Association Wisconsin

Breast Cancer Action

Breast Implant Safety Alliance

Consumer Federation of America

Doctors for America

Government Information Watch

Jacobs Institute of Women’s Health

Medical Device Problems

Medshadow Foundation


MRSA Survivors Network

National Center for Health Research

National Women’s Health Network

Our Bodies Ourselves

Patient Safety Action Network

SCAD Alliance

TMJ Association

USA Patient Network

Washington Advocates for Patient Safety



The Honorable Patty Murray, Chair

Senate Committee on Appropriations

The Honorable Susan Collins, Vice-Chair

Senate Committee on Appropriations

The Honorable Kay Granger, Chairwoman

House Committee on Appropriations

The Honorable Rosa DeLauro, Ranking Member

House Committee on Appropriations

The Honorable Bernie Sanders, Chair

Health, Education, Labor & Pensions Committee

The Honorable Bill Cassidy, Ranking Member

Health, Education, Labor & Pensions Committee

The Honorable Cathy McMorris Rodgers, Chair

Energy & Commerce Committee

The Honorable Frank Pallone, Ranking Member

Energy & Commerce Committee

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