Posted 15 April 2015
The US Food and Drug Administration (FDA) is reaching out to the pharmaceutical and biopharmaceutical industries for input on which industry experts should serve on 18 of its influential advisory committees.
FDA's advisory committees are comprised of experts—approximately 8-17 of them per committee—which make recommendations to FDA on matters of policy and specific products. For example, a committee might recommend a specific product be approved because of its favorable benefit-risk ratio. A committee might recommend new warning labels be added to an entire class of products. And one might recommend FDA scrap an existing FDA policy in favor of a new one.
While the advisory committee's recommendations are undoubtedly influential, they are also non-binding, though FDA follows their advice in the majority of cases.
The advisory committees are also made up of two types of experts: those with the power to vote on a recommendation, and those without such power.
One example of the latter are what is known as "industry representatives"—experts chosen to represent an industry by proxy to ensure broad interests are represented in each advisory committee meeting. For example, the expert might have deep insight into the way in which drug products are manufactured, how to run a clinical trial or the relative risk of a product. These insights can be crucial in ensuring a discussion does not lead to a recommendation which could inadvertently cause harm to a broader class of products or patients.
However, the power of these representatives to affect change is limited only to the power of persuasion. Unlike their non-industry colleagues, they are not permitted to vote on any issues before the committee.
New Nominees Sought
Now FDA is asking the pharmaceutical and biopharmaceutical industries to nominate persons they think would be acceptable to serve on the 18 advisory committees which advise its drug regulatory division, the Center for Drug Evaluation and Research (CDER).
In a 15 April 2015 announcement in the Federal Register, FDA said it is seeking nominations for the following committees:
- Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
- Anesthetic and Analgesic Drug Products Advisory Committee
- Anti-Infective Drugs Advisory Committee
- Antiviral Drugs Advisory Committee
- Arthritis Advisory Committee
- Bone, Reproductive, and Urologic Drugs Advisory Committee
- Cardiovascular and Renal Drugs Advisory Committee
- Dermatologic and Ophthalmic Drugs Advisory Committee
- Drug Safety and Risk Management Advisory Committee
- Endocrinologic and Metabolic Drugs Advisory Committee
- Gastrointestinal Drugs Advisory Committee
- Medical Imaging Drugs Advisory Committee
- Nonprescription Drugs Advisory Committee
- Oncologic Drugs Advisory Committee
- Peripheral and Central Nervous System Drugs Advisory Committee
- Pharmacy Compounding Advisory Committee
- Psychopharmacologic Drugs Advisory Committee
- Pulmonary-Allergy Drugs Advisory Committee
Anyone interested in participating on the committees may nominate themselves, FDA said. However, participation on the committees will be selected by industry organizations, FDA wrote in its Federal Register notice. If no candidate is selected, or if industry groups are unable to select a candidate, FDA may select a member to represent industry interests.
Federal Register Notice