FDA wants more oversight of compounding pharmacies
NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.
According to a draft of testimony submitted ahead of a hearing before the House Committee on Energy and Commerce, Hamburg detailed the FDA's response to the outbreak, linked to contaminated steroid drugs from the New England Compounding Center in Framingham, Mass., and also the agency's limited ability to regulate pharmacy compounding.
"[The] FDA's ability to take action against compounding that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to legal challenges to [the] FDA's authority to inspect pharmacies and take appropriate enforcement actions," read a draft of Hamburg's testimony submitted before the hearing.
As of Monday, the oubreak, linked to doses of the steroid methylprednisolone acetate contaminated with fungus, had sickened 438 patients and killed 32, according to the Centers for Disease Control and Prevention.
In her testimony, Hamburg suggested greater federal oversight of what she called "nontraditional compounding," meaning pharmacy compounding of drugs that could potentially pose higher risks to patients for various reasons, such as sterile compounding, shipments of compounded drugs between states or dispensing through third parties. She said the FDA should have the power to collect and test samples of compounded drugs and examine compounding pharmacies' records, as it does when inspecting other manufacturers and to require that pharmacies involved with nontraditional compounding register with the agency.
"Nontraditional compounding should, because of the higher risk presented, be subject to a greater degree of oversight, with the riskiest products subject to the highest level of controls, such as appropriate current good manufacturing standards established by [the] FDA," Hamburg's testimony read.
Last month, the FDA released a copy of its inspection report of the NECC, saying that during an inspection of the pharmacy, inspectors found contaminated products and problems with the pharmacy's ability to maintain its clean room, an enclosed space designed to have a controlled environment to ensure a sterile environment for drug compounding at the NECC's Framingham, Mass., pharmacy.
The FDA said that the inspectors "observed conditions and practices that, in their judgment, may indicate violations of the Federal Food, Drug and Cosmetic Act, or related regulations," but that the report was not a formal determination that the NECC had committed any violations.
These included contamination with mold, bacteria and "foreign matter" in several areas and on equipment in the pharmacy designed to be kept sterile and sanitary. Inspectors found 83 vials of methylprednisolone acetate, the injectable steroid linked to the meningitis outbreak, that contained "greenish black foreign matter," while 17 contained "white filamentous material."