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Page 731 – Stanford Medicine X

Product Approvability Recommendations from FDA Advisory Committees: Inconsistently sought, indirectly obtained

Joseph Gulfo jvgulfo@fdu.edu


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. In this paper, we examine recent AdComm meetings to find whether the FDA is obtaining Panel recommendations on drug and device approvability in accordance with these laws and regulations. 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. We recommend implementation of several practices to ensure that FDA succeeds in obtaining clear recommendations when it convenes Panels to address product approvability.

AdComm meetings are critical hearings, coming at the end of the lengthy, difficult, and expensive processes by which drugs and medical devices are developed. During these sessions, all the data available after years and years of testing are summarized and debated. The new products are thoroughly reviewed—the safety and effectiveness data and all shortcomings of the development process. After all is said and done, after the good, the bad, and the ugly has been aired and debated for hours, it is most appropriate to have a final straightforward vote on whether clinicians on the Panel want to use the drug, that is, recommend its approval. That is precisely what the law governing Panels intends.

Uncertainty is the most powerful deterrent with respect to investment in life sciences companies. Since real medical innovation occurs mostly in small companies that are dependent on financing from private and public markets, uncertainty stifles innovation. Rules and standard procedures help investors and drug developers understand and navigate unknown terrain. Consistent enforcement of the rules “de-risks” the process. There are many unknowns in the costly, arduous, and time consuming drug development process; one of them should not be how the FDA will run the company’s AdComm meeting.

It is certainly necessary, often, for the FDA to have latitude to exercise discretion at different points in the drug development and review process, and, accordingly, FDA is accorded great discretion in many matters. But we do not believe that whether approvability questions are posed, or the manner in which they are asked, should be matters that are subject to agency discretion. Importantly, the law does not require the FDA to follow Panel recommendations, therefore, conducting approvability voting in a direct and unambiguous manner does not pose a risk of undermining FDA’s authority. 
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