Has FDA Been Corrupted? Tough Questions, Touchy Answers
(Thursday, July 1, 2021)
Suggestions have been made in the media about the impropriety of the process followed by FDA during the review and approval of Biogen’s Aduhelm. While the process followed may not be outrightly illegal, was it ethical, and was it corrupt? It is important to review the facts before we make judgements. The Chief of FDA’s Neuroscience division, Dr. Billy Dunn, met with Biogen’s CEO in a previously undisclosed meeting two years before the controversial decision and made suggestions that changed the regulatory pathway leading to Aduhelm’s approval. Meetings between FDA and applicants are critical for stalled programs, particularly, when there are important regulatory and scientific questions holding the application back. FDA meetings have been touted to be one of the most important resource available to both the applicants and FDA reviewers to discuss and find solutions to road-block issues. In the case of Aduhelm, it was a life-changing decision for the product to pursue surrogate markers as the primary endpoint via the accelerated approval pathway, since the previous primary endpoints were inconclusive in showing the drug’s benefits. The change in the regulatory pathway allowed the FDA to use a very different standard for its decision. On the face of it, there is potentially nothing illegal about this meeting, but there are concerns about how this meeting was disclosed. Prior to the media expose, this meeting was not publicly known. FDA publishes a summary of FDA-applicant discussions in the approval package once the drug is approved. But these summaries only discuss the discussions during the NDA/BLA review process, not during the IND phase. Because the meeting in question happened about a year before the NDA was even submitted, the approval package did not include details of this meeting. It is most likely that Dr. Dunn did not intentionally hide this this meeting from public, and it’s also safe to assume that he involved other reviewers in his recommendation to Biogen. But Biogen’s announcements around the time of the meeting indicate that the “recommendation” went beyond a simple regulatory advice and included assurances from the FDA to Biogen of possible approval of the drug based on the new direction. Again, even if FDA assured Biogen that changing the regulatory pathway to accelerated approval increases the odds of the application getting a favorable outcome, it would not be illegal. Afterall, most FDA suggestions are intended to help applicants get a favorable outcome. So, it the process is not illegal, or unethical, what about the insinuation that the process is corrupt? It has been suggested that FDA’s revolving door, where FDA’s former employees get lucrative jobs paying several folds their FDA salaries working for the same companies they once regulated, leads to corruption of the process. There is no law against a former FDA employee taking a job at a formerly regulated company; actually, companies tout their ability to hire former FDA staff. And it can be argued that it paints any decisions made by FDA reviewers. But until there are rules banning FDA employees from taking such jobs with obvious conflict, that insinuation will stand. And there is nothing FDA can say to defend that.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC