Advisory Committees: Another Set of Regulatory Eyes, Ears and Voices
By Lois Chester, Office of CommunicationsEven FDA can sometimes use the advice of outside experts. And when there is the need, advisory committee meetings are called. In fact, the agency uses 51 committees and panels to obtain independent expert advice on scientific, technical, and policy matters.
These committees provide advice on specific agency actions such as drug approvals and label modifications, as well as advice on agency guidances, policies, and regulations. While they can make recommendations, committees have no authority to make decisions on behalf of the agency, and FDA does not have to follow their recommendations.
Advisory committees at the Center for Drug Evaluation and ResearchAdvisory committee meetings provide CDER with additional expertise to help with regulatory decisions. The open meetings make FDA processes more transparent and help maintain the credibility of CDER’s decisions. In addition, they provide a way for the public to have input into important health care decisions.
The Center currently has 17 advisory committees. Each drug review division within CDER is closely aligned with the advisory committee that deals with its particular subject area. For example, the Oncologic Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of products used to treat cancer, and the Antiviral Drugs Advisory Committee is concerned with drug products related to HIV/AIDS .
Generally, the review division determines if a meeting is needed. After thoroughly reviewing the product application, if the meeting is product-specific, the review division identifies the specific expertise needed then develops briefing materials, presentations, and questions that will provided to the committee members and the public.
Open to the publicMost of CDER’s advisory meetings are open to the public, and all include a public hearing session where individuals can provide information or express their views to the committee. Meetings are only closed to the public when company trade secrets or confidential commercial information are scheduled to be discussed, and the closure of the meeting must be approved by the Commissioner’s office.
Committees primarily consist of researchers and scientists in relevant fields, and consumer and patient representatives. Additionally, CDER advisory committees include a non-voting industry member who represents the viewpoint of regulated industry. Members are appointed by the FDA Commissioner to serve up to four years. They are considered special Government employees and must follow the same regulations that apply to all federal employees.
Conflicts of interestConflict of interest issues present a challenge for CDER when identifying scientific experts to serve on advisory committees. The academicians and scientists conducting clinical trials for pharmaceutical companies are often the same experts needed on the committees; this can make it difficult to find candidates.
Before every advisory committee meeting, FDA evaluates each member for conflict of interest related to the particular meeting topic. If a member has a financial conflict of interest and FDA needs that member to attend the meeting, a waiver may be considered.