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 state pharmacy boards that have traditionally overseen the space.
Compounding pharmacies mix customized solutions, creams and other medications in doses 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.
Traditional compounding pharmacies will continue to be regulated by state pharmacy boards. However the bill sets minimum standards for ingredients used by all compounding pharmacies.
The bill identifies "manufacturing compounders" 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.
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.
However, previous congressional efforts to regulate compounders 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 waged a grass-roots campaign 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.