News Feature | January 21, 2014

The FDA Charters A Vaccines And Related Biological Products Advisory Committee

Source: Pharmaceutical Online

By Cyndi Root

The Food and Drug Administration (FDA) updated the Vaccines and Related Biological Products Advisory Committee page on its website on January 9, 2014. The information presented helps interested parties learn about the committee’s charter, its authority, and the scope of its activities. The purpose of the committee is to “ensure safe and effective drugs for human use.”

Jill Hartzler Warner, J.D., Associate Commissioner for Special Medical Programs (Acting) at the FDA signed the approval for the committee on October 31, 2013, and documents were formally filed on December 31, 2013. The committee terminates automatically in two years unless renewed through appropriate channels.

Scope of Activities

The Vaccines and Related Biological Products Advisory Committee was chartered under several federal laws and the Federal Advisory Committee Act. The committee provides insight to the Commissioner or acting officials in the FDA in regards to human drugs and other products that the FDA is responsible for. Committee members evaluate vaccines, drugs, and other biological products. Members review drugs and make recommendations based on effectiveness, safety, and intended use. Additionally, members consult research performed by the FDA in order to make recommendations.

The Center for Biologics Evaluation and Research provides support and management services. The annual cost for the committee including travel expenses and compensation for members is estimated at $350,000. Support services including personnel costs are estimated at $230,000 annually. The FDA intends to send a designated Federal Officer (DFO) to each meeting. This person will enforce regulations and procedures, approve meeting agendas, supervise subcommittee meetings, and adjourn meetings as necessary. Committee meetings will be held four times a year, with notice given to the public, and will be open to the public unless closed at the direction of the Commissioner.

The committee consists of 12 people selected by the Commissioner. Members are authorities selected from a wide range of specialties including molecular biology, virology, biostatistics, and infectious diseases. The committee may include voting and non-voting members with industry and consumer interests. The Commissioner may ask members of other FDA committees to provide expertise at times. The committee may make use of subcommittees to address certain issues and make preliminary recommendations.

Records of the meeting are processed according to General Records Schedule 26, Item 2. In keeping with The Freedom of Information Act, 5 U.S.C. 552, records are available to the public to read and copy. At minimum, reports will contain information on the attendees and the recommendations made.