Product Approvability Recommendations From FDA Advisory Committees:

Abstract

Background:

Divisions within the Food and Drug Administration (FDA) often convene meetings of advisory committees, also known as AdComm or Panel meetings. The purpose of many AdComm meetings is for the FDA to obtain outside advice and recommendations on whether to approve a new drug or medical device. Laws and regulations indicate that such Panels are to provide recommendations regarding the approvability of the drug or device by FDA.

Methods:

We examine recent AdComm meetings, including a systematic review of drugs and biologics AdComms between 2011 and 2016, to find whether FDA is obtaining Panel recommendations on drug and device approvability in accordance with these laws and regulations. (This article does not contain any studies with human or animal subjects performed by any of the authors.)

Results:

We find that Panel recommendations on approvability are often not obtained. We further find that, in most cases where Panel recommendations are obtained, voting procedures are such that those recommendations address product approvability in only an indirect manner.

Conclusions:

While FDA rightly has the authority to exercise discretion in many aspects of the product approval process, we believe that it must obtain clear recommendations whenever it convenes a Panel to address product approvability.