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FDA Advisory Committees: Why They Matter To You

8/ 27


AUTHOR: 50SN Staff

DATE: Aug 27, 2020


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FDA Advisory Committees: Why They Matter To You

The FDA uses advisory committees to provide independent expert advice to the Agency in its evaluation of these products and allows the Agency another channel to hear directly from patients on these topics. FDA advisory committees are required to have public meetings in order to hear from experts and the community at large. These meetings are an opportunity for patients and providers to give firsthand testimony about certain diseases and treatments that the committee may be studying. While the FDA ultimately has the final say on whether new or novel treatments are approved for use, they rely on advisory committees to provide the first line of recommendations so that they can weed out the most important facts and data points from the entirety of the data. If these committees were to be disbanded, it would remove a valuable mechanism for patients to participate in the regulatory decisions that govern their lives.

Some history and background on FDA Advisory Committees

FDA advisory committees work to protect and promote public health by bringing together independent experts for their advice on scientific, technical, and policy matters. There are 31 advisory committees within the FDA, each with their own number of members and panels depending on the focus of the committee. These committees are established to provide functions which support the FDA’s mission while meeting the requirements set forth in the Federal Advisory Committee Act of 1972, which placed regulations on these committees to ensure open meetings, chartering, public involvement, and reporting. The Act also defines a committee as “an entity that is used by an agency of the federal government to gain advice or recommendations.” Committees are either mandated by statue or established at the discretion of the DHHS and they must be renewed at two-year intervals unless the committee charter states otherwise. Committees normally contain nine “fixed members” including a chairperson and members can include scientific experts, consumer representatives, industry representatives, and patient representatives. At their core, Advisory Committees weigh the available evidence and provide scientific and medical advice on the safety, effectiveness, and appropriate use of the products that the FDA regulates.

Examples of FDA Advisory Committees include:

  • Advisory Committee on Immunization Practices
  • Blood, Vaccines, and Other Biologics Advisory Committee
  • Bone, Reproductive and Urologic Drug Advisory Committee
  • Arthritis Advisory Committee
  • Food Advisory Committee
  • Human Drug Advisory Committee
  • Medical Devices Advisory Committee
  • Patient Engagement Advisory Committee
  • Pediatric Advisory Committee
  • Radiation-Emitting Products Advisory Committee
  • Risk Communication Advisory Committee
  • Tobacco Products Scientific Advisory Committee
  • Veterinary Medicine Advisory Committee

Protect this important venue for patient input. Take action:

Without FDA advisory committees, not only would patients lose a method to participate in stakeholder discussions, but it would also increase the logjam at federal agencies and likely cause further delays to approval for new treatments. We urge the FDA to continue to allow to the patient participation with these advisory committees. Here are three ways you can help:

  1. Contact your elected representatives: click ‘HERE’ to find your federal representatives to call and/or email to let them know why this matters to you.
  2. Contact the FDA directly: call the Office of the Commissioner of the Advisory Committee Oversight and Management Staff at (800) 741-8138 or (301) 443-0572 to ensure they know the value of the patient voice.
  3. Join others like you by signing up for GHLF’s 50-State Network of patient advocates.