As new treatments, drugs and medical devices come to market the FDA is charged with making sure that they are both safe and perform as represented. Products that come under review include items such as human and animal drugs, blood and other biological products, medical devices, and foods.
The process of evaluating these products has become increasingly more complex as technology advances. Often, the evaluative process requires many areas of expertise. The FDA turns to outside experts for advice in their process of reviewing these drugs, treatments and medical devices. To access this expertise the FDA often uses advisory committees in their approval process. These committees are composed of groups of experts from outside the agency.
The advisory committees are specifically designed to provide independent, professional expertise related to specific questions posed by the FDA. The advisory committee meets with members of the FDA as well as the sponsor (applicant for approval or manufacturer of the product) to review and explore the pertinent data submitted by the applicant. The committees usually hear a presentation from the sponsor after which they have the opportunity to ask questions and follow up on concerns about the data submitted, pertaining to the questions asked by the FDA.
The FDA poses specific questions to an advisory committee that they wish answered to better allow a thoughtful and comprehensive decision. The committee’s specific job is to provide informed answers to these questions. The advisory committee will discuss the FDA’s questions after reviewing all submitted briefing materials that contain background information such as available studies on the product as well as information provided in the sponsor’s presentation.
Somewhere in the process, usually after the sponsor has finished their presentation, the committee chair will call on individuals from the community to make public comment about the treatment being reviewed. At this time consumer advocates can share the communities concerns about the product.
Once the sponsor’s presentation has been completed and the community has used its allotted time, the FDA’s representatives will ask additional questions of the sponsor to elucidate any unclear issues. The advisory committee will then vote on the questions posed by the FDA (i.e. Has this product demonstrated its efficacy?). The committee’s vote serves only as a recommendation to FDA as the agency makes all of the final decisions. (In the Provenge issue the committee voted and recommended that the FDA approve the treatment, however, the FDA reserved their right to make a different decision and sent the sponsor back to develop additional information).
FDA currently has 48 technical and scientific advisory standing committees. A committee generally includes a chairperson, several scientists and health professionals, an industry representative, a consumer representative, and sometimes a patient representative. As required the exact composition of an individual committee can be modified to modify the available expertise.
The consumer representative is usually a health professional with links to consumer advocacy groups or community-based organizations. FDA may also invite a patient representative to participate in a committee. A patient representative has knowledgeable about, or may even have, the disease or condition under discussion by the committee. While contributing to the scientific discussion, consumer and patient representatives bring to the committees an awareness of concerns of patients and family members directly affected by a serious disease.
The two most recent advisory committee meetings evaluating drugs or treatments specific for prostate cancer were the Provenge and Satraplatin hearings.
Joel T Nowak MA, MSW