The Biogen Decision Begs a Question: Do We Need FDA Advisory Committees? 
(Thursday, June 17, 2021)
Although FDA is not bound to accept the recommendations of its Advisory Committees (Ad Coms), it mostly does. But it is the times when FDA went against the Ad Com, that raises the question, do these committee serve the purpose they were intended? Some of FDA’s most controversial, high-impact decisions in recent times have been either against the Ad Com’s recommendations, such as that for Biogen’s new drug for Alzheimer’s disease, Aduhelm, or where Ad Coms gave a razor thin support with strong objections from some members such as Sarepta’s treatments for DMD, multiple cancer drugs, and female libido drug, Addyi. FDA’s Ad Com meetings have always been newsworthy events where FDA publicly discusses important new products prior to its decision on their market approval applications. It helps the public know about the intricacies of the clinical data before the FDA decision. The Ad Coms also allow non-FDA scientists to critique the data and provide fresh perspectives. But Ad Coms are held at the very end of the regulatory process, usually a few weeks or even days before FDA’s deadline to make a decision regarding an application. Most likely, by that time, FDA has already internally decided the direction it wants to take on a given application. Since FDA decides the agenda and the information discussed at the Ad Com meetings, it can greatly influence the discussion in these meetings. Hence, over time, it seems that the Ad Coms have been used by FDA to rubberstamp the decisions it has seemingly already made. FDA does not explain when it goes against the recommendations of its own Ad Coms, or when it seemingly cherry picks split votes. The Biogen case was the most egregious violation of the trust that members of an Ad Com place in FDA, but it is not the first time. If Ad Coms are merely there is agree with FDA, then the whole exercise of public discussion is sham. It could be addressed by having FDA set clear criteria as when it would/could disagree with its Ad Com. The controversy is by the opaqueness of FDA’s internal review processes for Ad Com advise. And FDA has abused that opaqueness to the detriment of the credibility of the Ad Com meetings. Also, having Ad Com meetings earlier in the regulatory process may be more productive than those at the tail end, as then FDA would likely not have completed its review and be more open to advise from its Ad Coms. FDA needs to take immediate steps to recover the lost credibility of the Ad Com, otherwise, it won’t be long before these meetings become just a public show of a sham exercise.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
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