Are FDA Advisory Committees Doomed?

FDA commissioner Martin Makary, through his actions rather than his words, has given the impression that he does not value the agency’s advisory committee system. That’s the analysis of FDA Matters founder Steven Grossman, who notes that Makary has the prerogative to run the agency as he deems best, so long as it conforms to the law.

Grossman notes recent reports in health media seeming to suggest that Makary wants to eliminate some, if not all, advisory committee review of new drugs. He says the rationale given for the change was that since FDA is now publishing complete response letters publicly as they are issued to sponsors, companies and stakeholders can learn about the agency’s thinking by reading the letters.

“An advisory committee review of a new drug is about FDA making the right decision on the product after consulting experts and receiving input from the public (who can avail themselves of the open comment period),” Grossman writes. “Not only does the advisory committee’s discussion contribute to the agency’s yes/no decision, but it may also influence labeling, post-approval studies, and whether a Risk Evaluation and Management Strategy is needed. Sponsor and public education about FDA’s views and process for new drugs may occur as a byproduct of an advisory committee meeting, but it is never the main point.”

Grossman speculates on two possible reasons why Makary would want to change the advisory committee policy and process. First, he says, FDA may not want to expose its pending product decisions to a process that it can’t control. And second, FDA may feel that it has sufficient expertise to make product decisions using FDA staff and supplementing that with advice from other public health agencies, the agency’s paid consultants, and the extensive professional network of Makary and the Center directors.

“Of course,” he says, “I am speculating on these two possibilities. Over time, we will have a better idea if these alternative explanations have merit.”