The purpose of the US Food and Drug Administration (FDA)’s Advisory committee meetings (AdCom) is to provide independent advice and recommendations on scientific and technical matters related to the development and evaluation of products regulated by the agency. The FDA’s approach to AdComs has been evolving in recent years and both FDA Commissioner, Robert Califf, and retired principal deputy commissioner, Janet Woodcock have stated the process needs restructuring.
Through the advisory committee meeting process, the FDA is able to engage external professional expertise in the review process and give the public a platform in which to share their opinions. The FDA weighs the advice from the AdCom meetings but is ultimately responsible for the final decision regarding the pending regulatory action, including the approval or denial of an application. Research shows that historically, the FDA is strongly aligned with the recommendations from the committees, approving 97% of drug applications when the committee advised on approval.[1]
Recent controversial regulatory decisions, including the approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), despite an advisory committee vote against approval, serve as a catalyst for change. In this case, several AdCom members resigned over the disparate outcome. Additional reasons the FDA has cited as a need for change include public misunderstanding and misinformation about the emergency use approvals for Covid-19 vaccines and a general mistrust of the drug approval process in general. As a result, the FDA has stated publicly that they intend to make systematic changes to the process, including, but not limited to, the necessity of the committee vote, the timing and format of the meetings, and finding the ‘right’ experts for the panel at these AdCom meetings.
The pharmaceutical and biotech industries are anxiously awaiting the specifics on the anticipated systematic reforms to the AdCom meeting process. Based on our more than two decades of experience in guiding clients on how to prepare for an upcoming AdCom meeting, Lumanity has developed a guide on anticipated changes to the FDA AdCom system and how to be prepared for them.
Complete the form to download our top five most likely changes to FDA advisory committees and implications to the industry, and don’t miss our upcoming dialogue with previous committee members and industry representatives providing input on the expected changes and implications for your future AdCom meeting.
Contact us for more information on how we can help you prepare for your next committee meeting.
[1] Daval, C. Joseph Ross, et al. “Association of Advisory Committee Votes with US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021.” JAMA Health Forum. Vol. 4. No. 7. American Medical Association, 2023.https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807050
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