FACA, the FDA, and fixing it

Let me tell you about the obscure law that shapes the way the public engages with the FDA. How it’s failing. And how we can fix it.

Say you are an executive agency tasked with making a decision on whether a new type of medication should be approved for treatment. Your staff is broadly knowledgeable about drugs, sure, but not this specific one. Not for the specific conditions it promises to alleviate. Thanks for the Federal Advisory Committee Act, you can call on experts to advise your next steps.?

Federal advisory committees (ACs) take many forms – working groups, panels, commissions, task forces, among others – but they all serve the same vital role: connecting regulators to outside experts and their expert recommendations.

At the Food and Drug Administration, ACs are essential to the agency’s regulatory engine. They provide independent and unique windows for experts and the public to comment on cutting-edge medical products and treatments. They are also crucial transparency measures for an agency grappling with declining public trust. Except the FDA has overruled AC recommendations for major decisions concerning opioids and other medications; high-profile resignations have further exacerbated trust issues; and the FDA is calling fewer and fewer ACs.

Over the past 6 months, FAS Health Regulatory Specialist Cheri Banks, MPH (along with Grace Wickerson ) interviewed ACs members on their experiences in service, what they see as the hardest barriers to progress, and what process/regulatory/statutory changes they would like to see made so that ACs can provide the vital external input they promise.?

Last week, we published the results of these interviews in five case studies designed to lay out the challenges advisory committee members want to see tackled so they can get back to bringing their knowledge to the table. You can read each of them below.?

• The Future Of Voting For FDA Advisory Committees
• FDA Staff And Leadership Disagreements And The Role Of The AdComm In The Regulatory Process
• Leveraging AdComm Membership
• The Role Of Patient Advocacy In The AdComm Process

What’s next? That’s up to the FDA. In each of the above case studies, we’ve made recommendations that balance the needs of federal agencies, the experts they lean on, and the public they serve. Some of our favorite ideas in there are:

• Retaining voting as a mandatory procedure for all AdComm meetings that review medical products
• Streamlining the conflict of interest ( COI) process to prevent duplicative work and making it easier to identify individuals with financial conflicts
• Increasing efforts to engage the public on an ongoing basis in the regulatory process

If these solutions motivate you, we ask you to join us in creating a vision for how the FDA and other federal agencies can better engage external scientific experts and the public to address critical policy and regulatory decisions. Register for our in-person/virtual workshop here.?