Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards under a new Senate proposal introduced Friday.
The draft bill is the first Senate effort to address the recent outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others.
The wave of deadly fungal infections was identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.
The new proposal would subject such large compounding operations to direct federal oversight by the Food and Drug Administration, rather than the state pharmacy boards that have traditionally overseen them.
Compounding pharmacies mix customized solutions, creams and other medications in formulas specified by a doctor's prescription. Over the last two decades though, larger compounding operations have emerged that produce medications in bulk and ship them across state lines.
The New England Compounding Center, which triggered the meningitis outbreak, shipped more than 17,600 doses of its pain injection to 23 states.
Last week, FDA Commissioner Margaret Hamburg said her agency was not aggressive enough in policing the company because of the conflicting patchwork of state and federal laws that govern pharmacies. The Senate bill is designed to clear up that ambiguity.
"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," said Sen. Tom Harkin, D-Iowa, who chairs the Senate Health, Education, Labor and Pensions Committee. The bill was drafted with support from Republicans on the committee, including Sens. Lamar Alexander, R-Tenn., and Pat Roberts, R-Kan.
The bill identifies "compounding manufacturers" as pharmacies that produce injectable drugs and ship them across state lines without patient-specific prescriptions from doctors. These operations will have to register with the FDA, report the drugs they make and meet standards similar to those required of drug manufacturers.
Traditional compounding pharmacies, generally small operations that work with individual doctors, will continue to be regulated by state pharmacy boards. But the bill sets minimum standards for ingredients used by all compounding pharmacies.
As the first bipartisan bill in Congress aimed at addressing last year's outbreak, observers say the Senate legislation has the best chance of becoming law. Several Democrats in the House of Representatives have introduced similar measures, but Republicans who control that chamber have shown little interest in passing new compounding legislation.
Previous congressional efforts to regulate the compounding pharmacies have been scuttled before, stretching back to the 1990s.
In the last attempt, senators including Roberts and Ted Kennedy, D-Mass, circulated a bill in 2007 that would have given the FDA more power to inspect compounders and set standards for sterile medications. But the legislation was abandoned after compounding pharmacists campaigned against it, visiting Capitol Hill and lobbying in Senate offices.
The industry's main trade group, the International Academy of Compounding Pharmacists, spent about $1 million lobbying Congress in the last decade, according to data from the Center for Responsive Politics.
The group said in a statement Friday that new categories like "compounding manufacturer" create "more confusion and further blurs the jurisdictional authority of regulators."
"IACP reiterates its position that state boards of pharmacy are responsible for the licensing and oversight of compounding pharmacies and the FDA is responsible for overseeing and regulating pharmaceutical manufacturers," the group said in an emailed statement.