Questions and Answers Regarding Advisory Committee Membership
What is an FDA Advisory Committee?
Advisory committees provide FDA with independent advice from outsiders and political cover in the event that something goes wrong. The committees provide advice to the Agency, but actual decisions are made by FDA, because Advisory committee members are not always cognizant of the larger-scale political and regulatory issues attached to each application.
How does an individual become a member of an FDA advisory committee?
Just volunteer. FDA does not pay well, and since we retain the option of ignoring advice, membership offers an experience of learned helplessness. FDA does not provide reimbursement for the treatment of depression associated with repeated exposure.
What are the qualifications of an advisory committee member?
Persons nominated as scientific members must be technically qualified experts in their field and have experience interpreting complex data. While we would prefer for AC members to not have ties to industry, we have noticed that this requirement essentially rules out most candidates meeting the first criterion. The requirement has thus been changed to: Advisory Committee candidates should not be employed by the sponsor of the drug under consideration-at least, not yet.
Can health professionals serve as consumer representatives?
Whatever. We don’t particularly take consumer or patient representatives seriously.
Where are the advisory committee meetings held?
The beautiful Bethesda/Rockville area, which is convenient to many national landmarks, sporting events, and fine restaurants in Washington DC.
Are advisory committee members paid?
As we said, yes, but not well.
How often are advisory committee meetings held?
As seldom as possible, but as often as needed to avoid the appearance of unilateral decision-making.
What should prospective members know about the role?
There are certain areas of regulatory concern that may cause FDA’s adherence to AC recommendations to be limited. Just to take one potential issue, chosen at random, as an example:
FDA has historically been very concerned about the potential misuse of a drug approved for the treatment of cognition. It is one thing for patients diagnosed with dementia to receive a minimally, transiently useful pharmacologic product, but if an effective procognitive drug were to be made available to broader segments of the population, FDA continues to be concerned that such an approval might trigger a tidal wave of abuse in the service of cognitive enhancement, with serious social consequences. Where would we be then? Overly preoccupied with beating Deep Blue at chess, Go, or poker? Contemplating the finer points of culture, philosophy, and existential angst? We’re not France. And even worse, there would be no one paying attention to food production, sewer systems, air traffic control, and…regulatory oversight. In other words, the end of civilization and employment as we know it. FDA values a paced, evolutionary approach to societal change. You don’t. So if you vote 8-2 (just to pick a number at random) for the approval of a label-extension covering cognition, for a drug owned by companies that are not even based in the US, do not be surprised if we ignore you. Get over it. The buck stops here, and so does innovation. We’re FDA–this is what we do.
(Ed. Note: For those not following the topic, this is in reference to Brintellix)