WASHINGTON -- A bill to strengthen federal oversight of large-scale pharmaceutical compounders was signed into law Wednesday by President Barack Obama.
"Tennesseans deserve this law to make it clear exactly who is in charge of overseeing each compounding facility, so there will be no questions about who's on the flagpole," said Republican Sen. Lamar Alexander of Tennessee in praising the president's action.
The bill, called the Drug Quality and Security Act, is intended to address the regulatory gaps between the federal Food and Drug Administration and state pharmacy boards when it comes to large-scale compounders that ship their products in interstate commerce.
It was a response to nationwide shipments last year of contaminated steroid drugs from the New England Compounding Center that resulted in 751 meningitis cases nationwide, including 64 deaths. Tennessee, with 153 cases and 16 deaths, was second only to Michigan, which had 264 cases and 19 deaths.
Alexander, as a member of the Senate Health, Education, Labor and Pensions Committee, played a major role in drafting and passing the legislation. Congressional hearings started a year ago this month. The bill was unanimously approved on voice votes in both the House and Senate.
Traditional compounding -- pharmacists at local drugstores creating customized medicines in response to individual prescriptions -- has long been under state regulation, while the FDA concentrated on overseeing manufactured drugs.
But authority over large-scale compounders such as NECC, in Framingham, Mass., was blurred by various federal court decisions over the past 15 years, FDA officials said.
Supporters of the new bill say it will give the FDA clear authority to shut down firms such as NECC.
But critics say that authority would apply only after contaminated drugs reach the marketplace.
The bill makes it optional for large-scale compounders to register with the FDA as an "outsourcing facility," which would subject them to regular inspections and higher quality standards before they ship drugs. States would have authority over those that don't register with the federal agency.
Even firms that choose to register will be subject to less stringent requirements than traditional drug manufacturers, critics say.