How does the FDA use Advisory Committees to make decisions about drugs?

What is an FDA Drug Safety Communication?

FDA uses Drug Safety Communications to let health care providers, patients, and consumers know about newly observed potential risks of FDA-approved drugs and to offer advice as to how these drugs may best be used in light of this new information. For more information, visit our Drug Safety Communications page.


How does the FDA use Advisory Committees to make decisions about drugs?

When FDA faces important and challenging issues, the Agency often consults with one of its 49 technical and scientific Advisory Committees. FDA’s Advisory Committees supplement the Agency’s internal scientific and medical expertise as well as provide a public forum for participation by other stakeholders (e.g., patients, health care providers, academia and industry). Congress authorized the use of advisory committees in 1972 in the Federal Advisory Committee Act (FACA). This law requires open, pre-announced meetings; public access to deliberations, records and documents; opportunity for the public to provide comments; fairly balanced membership; and the evaluation of conflicts of interest for certain members. In general, the provisions of FACA apply when the government uses an outside group to provide advice and recommendations to a Federal official.

Typically, members of an FDA Advisory Committee are asked to meet with FDA officials to evaluate an FDA issue. Often, the Committees vote on questions asked to them by FDA. For instance, if research indicates a drug may be causing unexpected occurrences of liver failure, FDA may ask members of the Advisory Committee to study that research and then offer their views as to whether they believe the drug should be withdrawn from the market, kept on the market with new labeling and/or restrictions, or kept on the market without new restrictions. Importantly, although FDA values the input of its Advisory Committees, FDA is not obligated to follow the advice of the committees. Ultimately, all final decisions are the responsibility of FDA. For more information, visit the Advisory Committee page.

How does the FDA use Advisory Committees to make decisions about drugs?