FDA Advisory Committees

Abstract

FDA Advisory Committee meetings and their topics are always of great interest to some segment of the regulated community and the associated investment community. Because FDA will often involve an advisory committee for controversial or politically contentious issues such as approval of an OTC drug to induce abortion, or other especially difficult decisions or close calls, advisory committee meetings are often also of great interest to the general public. FDA Advisory Committee meetings are almost always public and although often covered by and reported about in the popular press, the committees themselves, their deliberations and their role or authority are frequently misunderstood. Although FDA advisory committees or panels may be asked to help or offer counsel to FDA over any matter related to FDA’s role, including policy and scientific questions, advisory committees attract particularly intense attention when they are asked to advise about an agent’s safety and efficacy, and to help in determining the so-called “benefit-to-risk ratio” as part of the final process in determining whether or not to give regulatory approval.