Alliance: 5 Recommendations to Improve Public Understanding of FDA Advisory Committee Function

The following statement was made today by Alliance President & CEO Sue Peschin, MHS, during the public comment portion of the U.S. Food & Drug Administration (FDA) public meeting: Optimizing FDA’s Use of and Processes for Advisory Committees:

Good afternoon. I’m Sue Peschin and I serve as President and CEO of the Alliance for Aging Research. Thanks to the FDA for hosting today’s listening session.

We share Commissioner Califf’s concern about the acceleration of health misinformation and disinformation. Two years ago, the FDA introduced its Rumor Control webpage to address, quote, “The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA.” In other words, FDA officials identified a pressing need to develop a webpage to address rumors about its own agency. This should concern all of us.

Public awareness and understanding of the role of FDA advisory committees is heavily shaped by press coverage of meetings. In many cases, reporters incorrectly frame an FDA Advisory Committee vote as having equal weight to the expert regulators at the FDA.

In fact, a local reporter I spoke with this week gave me permission to share that she first thought the 11-0 vote at this week’s donanemab meeting meant that the FDA approved the drug. Her misinterpretation was thankfully caught by a colleague. Many reporters have broad health portfolios and don’t know much about how the FDA works.

We have several recommendations for the FDA’s consideration to improve public understanding of advisory committees and their role:

1. The FDA should coordinate with the Association for Health Care Journalists to offer annual briefings on the basics of the FDA’s role and process—including the role and process for its advisory committees. We also recommend direct touch outreach to reporters who misrepresent the advisory committee’s role in their stories.
2. The FDA should develop standard language regarding the role of advisory committee members that should be read twice by the lead FDA official at the meeting—first, in opening comments and a second time before advisory committee discussion and voting.
3. We recommend the FDA release a just-the-facts statement after advisory committee meetings within an hour of the conclusion of the meeting that should describe what occurred and that the FDA’s approval decision will follow later. Since there are usually press stories on most advisory committee meetings, the FDA should be more proactive about providing accurate information to help reporters.  
4. All FDA centers should release press statements following approval decisions that involve advisory committee convenings. As an example, CDRH does not release statements, and often does not even note an approval until days after its decision. We want to link to the FDA when alerting folks to the FDA’s decisions, rather than to a company press release, since we do not endorse any therapy or take positions on FDA approval of specific medical products.
5. When there is a negative vote at an advisory committee, this puts political pressure on the FDA to defend itself. We’d like to see the FDA develop a public response on reasons for disagreement—especially in cases where advisory committee members go to the press with unfounded accusations against the agency.

Regarding voting, the Alliance believes that advisory committee members should not vote on direct questions about approval, or approval analogue questions such as questions regarding risk/benefit. We support advisory committee votes on other relevant scientific questions, and rich engagement in discussion to advise the agency.

Next, the FDA should provide robust training for new advisory committee members on: the basics of clinical development, regulatory decision-making, clinical trials, and patient outcomes data. The role of labeling should be explained to committee members—including how it serves to explain nuance and mitigate risks, so advisory committee members understand that the FDA does not regulate clinical care. 

Additionally, the FDA should create consumer-language abstracts on the review packet materials. This would help committee members better understand key takeaways and what the FDA wants their advice on.

Last, here’s something for the GSA and the FDA to consider on all the noise regarding conflicts of interest. Conflicts of interest inquiries should go beyond medical product industry connections to connections with anti-industry funders such as Arnold Ventures that have contributed tens of millions to some of the academics and group representatives who spoke here today. Those folks currently say nothing regarding those ties, and they are ones usually wreaking havoc on this process.

For example, regarding the 2021 Advisory Committee meeting on Aduhelm, anti-industry advocates may have viewed participating and then resigning from the committee as a PR stunt or platform to lambast the product under consideration, and the FDA more broadly. The ripple effects of their overblown self-importance contributed to multiple press stories and misinformation overload.

In fact, the FDA’s safety and effectiveness standards have remained steadfast. When it comes to evaluation of risk/benefit for patients the FDA’s senior career staff have acted with integrity, and carefully guarded their independence in an often, highly politicized environment.

Thank you again for today’s opportunity and for your service.