Physicians, pharmacists, industry representatives, and a consumer advocate have been named to the Food and Drug Administration’s new Pharmacy Compounding Advisory Committee.
The advisory committee, announced Dec. 16, will provide “advice on scientific, technical, and medical issues concerning drug compounding [and] make appropriate recommendations to the Commissioner of Food and Drugs.”
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The committee is made up of 14 members, two of whom are nonvoting, and includes representation from the National Boards of Pharmacy, the U.S. Pharmacopeia, pharmacists with current expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations.
“This is a key step toward implementing the compounding provisions of the Drug Quality and Security Act, and I expect we will benefit greatly from the advice and recommendations the members of the committee provide,” Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said in a statement. The law was enacted followed a deadly 2012 meningitis outbreak linked to a steroid from a Framingham, Mass.–based drug compounder.
The dermatologist on the panel is Dr. John DiGiovanna, staff clinician at the National Cancer Institute in Bethesda, Md. Dr. Ned Braunstein, vice president and head of regulatory affairs at Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., brings his expertise in clinical rheumatology and molecular immunology to the committee. Representing consumers will be Dr. Michael Carome, director of the health research group at Public Citizen in Washington.