At a recent congressional hearing spurred by the recent outbreak of fungal meningitis, the Food and Drug Administration (“FDA”) requested more power to regulate compounding pharmacies.
Dr. Margaret Hamburg, Commissioner of Food and Drugs at the FDA, explained at the hearing that compounded drugs are currently exempted from certain provisions of the Food, Drug, and Cosmetic Act, including (1) the premarket approval requirement for “new drugs,” (2) compliance with current good manufacturing practice, and (3) the requirement that the drugs bear adequate directions for use (in certain circumstances). According to Dr. Hamburg, these limitations, along with other gaps and ambiguities in the law, have suppressed the FDA’s ability to adequately regulate compounding. Dr. Hamburg requested a broad range of powers that would give the FDA increased jurisdiction over compounders, particularly nontraditional compounders. She also expressed that pharmacies should be prohibited from compounding certain products “under any circumstances,” including copies of FDA-approved drugs already available from other manufacturers, and certain complex dosage forms.
The FDA’s request for more power was met with mixed reviews. Some members of Congress indicated they may try to pass legislation by the end of the year, while others were adamant that the FDA already has enough authority - it just fails to properly exercise its powers to their full extent.