Oversight still has loopholes, some critics say
President Barack Obama signed into law on Wednesday legislation passed by Congress to define who has oversight for regulating compounding pharmacies in the wake of a fungal meningitis outbreak caused by tainted drugs.
U.S. Sen. Lamar Alexander, R-Tenn., welcomed the president's signature. He was one of the main authors of the Drug Quality and Security Act, the result of an agreement he reached with House and Senate health committee leaders to make injections of compounded sterile drugs safer.
"I have been working with my Senate colleagues for a year to find a solution that would help prevent a repeat of the terrifying meningitis outbreak that has killed 16 Tennesseans and made so many others so sick," Alexander said.
"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. This law affects the health and safety of millions of Americans. It is important in Tennessee to those 16 families who had a family member die. It is important to the dozens of families with a member of their family who is sick because of those injections. It is important to those families who may still become sick in our state and other states."
The ongoing outbreak has sicked 751 people throughout the country, with 64 deaths. Tennessee has been one of the hardest-hit states. The outbreak was tracked to a compounded steroid made by Massachusetts-based New England Compounding Center that was used in spinal epidurals and joint injections as a treatment for chronic pain.
Supporters of the legislation said it will give the U.S. Food and Drug Administration greater authority over compounding pharmacies, but critics say it still has loopholes.
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.
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.