AdComm Recommendations – How Often FDA Does Not Follow Them?

When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the meeting, the individual members read and review large briefing books. In addition, FDA staff have pored over materials and provided their opinion.

The day almost always goes the same in terms of agenda. The sponsor makes out their case and presents it. FDA presents their own findings. The public can provide comment during an open public comment period. Ultimately, the panel is called by FDA to answer a series of questions that are designed to provide advice on aspects of the drug application to help the agency in making an ultimate decision about approval. At or near the end of the day, the committee deliberates and votes yea or nay on one or more of the questions. Usually within a few months of that FDA announces a decision to the drug sponsor.

They are called advisory committees for a reason. They are there to provide advice. Advice, as we know, may or may not be followed. How often does FDA go against the advice of its advisory committees?

I went back to 2011 and looked at every advisory committee meeting and found that there had been a total since then of 231.  Of those 145 of were held to consider a treatment candidate for approval. Of those 145, decisions have been reached in 136 of them while the balance are still under consideration.

What is the track record of recommendations for or against approval?  It may surprise you to know, as it did me, that FDA Advisory Committees offered negative assessments and voted not to approve a drug 30 percent of the time (41 meetings). They voted to approve the drug 70 percent of the time (95 meetings).

So if a new drug application gets approved by the advisory committee, what are the chances that FDA will act against the recommendation?  Since 2011, I found that there were 7 times that a panel had voted against approval of a product where FDA went ahead and gave the product an approval. And I found that there were six times that panels recommended approval, but FDA decided not to do so.

In the aggregate that means that about 10 percent of the time overall – at least using meetings since and including 2011 through 2016 FDA decides ultimately on a different course than was recommended by its advisers. So next time someone asks the question, you have an answer.

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