WASHINGTON — 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 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 linked to New England Compounding Center, a Framingham pharmacy that regulators said was operating more like a manufacturer.
The 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 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 Senator Tom Harkin, the Iowan Democrat who chairs the Senate Health, Education, Labor, and Pensions Committee. The bill was drafted with support from Republicans on the committee, including Senators Lamar Alexander of Tennessee and Pat Roberts of Kansas.
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 ‘‘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.
As the first bipartisan bill in Congress aimed at addressing last year’s outbreak, the Senate legislation has the best chance of becoming law, observers say. Several Democrats in the House of Representatives have introduced similar measures, but Republicans who control that chamber have showed little interest in passing compounding legislation.
Previous congressional efforts to regulate the space have been scuttled before, stretching back to the 1990s.
In the last attempt, senators including Roberts and Edward Kennedy, Democrat of Massachusetts, 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 the Center for Responsive Politics.
— ASSOCIATED PRESS
Sarkozys showered Obamas with $41,000 in gifts
WASHINGTON — Former French president Nicolas Sarkozy and his wife, Carla Bruni Sarkozy, were clearly taken with President Obama and his family back in 2011.
The Sarkozys gave the Obamas about $41,000 worth of presents that year, becoming the most prolific foreign gift-givers to the first family, documents released Friday show.
The State Department’s Office of Protocol catalogues gifts to US officials from foreign leaders and publishes an annual accounting, often one or two years late due to processing. Among the goodies presented by the Sarkozys were a large black Hermes golf accessory bag worth $7,750, and two Baccarat crystal table lamps on silver pedestals worth $5,500.
Under law, most nonperishable gifts to US officials must be given to the National Archives or General Services Administration unless the recipient reimburses the Treasury.
— ASSOCIATED PRESS