Issue Date: December 24, 2012
Regulating Drug Compounders
On the heels of a multistate outbreak of fungal meningitis linked to a Massachusetts-based compounding pharmacy that produced injectable steroids, the Food & Drug Administration is pushing for new legislation that would strengthen its oversight of such facilities.
At a meeting with state pharmacy regulators last week, FDA Commissioner Margaret A. Hamburg proposed a system that would require large compounding pharmacies to register with FDA and undergo routine inspections by the agency. Compounding pharmacies are currently regulated at the state level, whereas drug manufacturers are regulated by FDA.
Compounding pharmacies typically mix small batches of drugs for individual patients. But over the past two decades some of them have become more like drug manufacturers, producing large batches of drugs that are distributed nationwide. Such large compounding pharmacies fall in a gray area between state and federal laws.
The recent meningitis outbreak, which has killed 39 people and sickened more than 600 so far, “shined a harsh spotlight on the fact that compounding pharmacy entities need a more comprehensive, consistent, and strong regulatory system,” Hamburg said. Under FDA’s plan—which requires congressional approval—states would continue to oversee traditional compounding pharmacies, but federal standards would be imposed on large compounders.
The proposed standards would be less stringent for large compounders than for drug manufacturers but more stringent than most current state regulations for compounding facilities.
Hamburg told reporters that she is “guardedly optimistic” that Congress will pass legislation next year that would give FDA authority to regulate compounding pharmacies. The roles and responsibilities of the agency with respect to compounding pharmacies are ambiguous under the current law, which has been subject to conflicting court opinions, she said.
But Republican leaders in the House of Representatives are showing little interest in pursuing such legislation. They claim that FDA is not cooperating with their investigation into the agency’s handling of the pharmacy responsible for the meningitis outbreak. At a hearing last month, lawmakers requested internal memos from FDA that they believe will show the agency had several chances to shut down the pharmacy but failed to do so.
“More than a month later, the FDA still has not produced its internal communications and documents,” Rep. Fred Upton (R-Mich.), chair of the House Energy & Commerce Committee, said in a statement after the FDA meeting. “Without this information, we are unable to identify any possible weaknesses and as a result, the necessary corrections.”
Other critics of the proposal say the plan would weaken FDA’s oversight of drug manufacturing by legalizing a new class of large compounders with substandard requirements for efficacy, safety, and quality.
FDA’s plan would “decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future,” said Michael Carome, deputy director of health research at Public Citizen, a consumer advocacy group.
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