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.
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:
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: