ABSTRACT
An integral part of the Food and Drug Administration (FDA)’s mission is to protect the public health by assuring the safety, efficacy, and security of human drugs, biological products, and medical devices. Because of the great magnitude and implication of this mission, the FDA occasionally calls upon external experts for advice and counsel. One of the ways in which the FDA can access external scientific expertise is through the use of the FDA advisory committee system. Advisory committees have been under considerable scrutiny over the past decades and the system has been the focus of congressional oversight. According to 21 Code of Federal Regulations (CFR) 14.5(a), “An advisory committee is
Introduction ....................................................................................................... 327 Historical and Regulatory Framework .............................................................. 328 Structure ............................................................................................................ 330 Composition ...................................................................................................... 330
Membership Type ......................................................................................... 330 Qualification Requirements .......................................................................... 332 Appointment Process ................................................................................... 332 Membership Training ................................................................................... 333
Conflicts of Interest ........................................................................................... 333 Conflict of Interest Waivers .......................................................................... 334 FDA-Initiated Conflict of Interest Studies ................................................... 335
Operation ........................................................................................................... 338 Industry Perspective .......................................................................................... 340
Affecting FDA’s Decision to Call a Meeting ............................................... 340 Preparing for the Advisory Committee Meetings ........................................ 341
Success Criteria: Dedicated Team ........................................................... 341 Success Criteria: External Expertise ....................................................... 342 Success Criteria: Rehearsal ..................................................................... 342
After the Advisory Committee Meetings ..................................................... 343 Conclusion ........................................................................................................ 344 References ......................................................................................................... 344
utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner.” Utilizing advisory committees, the FDA can seek advice and input from scientific and medical experts, consumers, and patient advocacy groups on a number of issues ranging from approvals of new medical products to providing guidance on appropriate methods of clinical investigation. The advisory committee system is most frequently employed in reviewing products or topics that are controversial or novel; however, there are no concrete guidelines as to when to expect using an advisory committee. In addition, the FDA is not bound to the recommendations of the advisory committee.
