Wednesday, September 25, 2013Liz Wolgemuth 202-224-8584
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"The FDA commissioner has warned us that, without fixing oversight, a similar outbreak will happen again, so I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who’s on the flagpole—who’s in charge—of overseeing their compounding practices.” – Lamar Alexander
WASHINGTON, Sept. 25— Sen. Lamar Alexander (R-Tenn.), the senior Republican on the U.S. Senate health committee today announced that leaders from the Senate and House committees that oversee health policy have reached an agreement on legislation to help ensure the safety of compounded drugs and to track prescription drugs from the time they’re manufactured to the moment they are picked up at a drugstore. The House of Representatives may take action on the legislation this week, and Alexander said he hopes “the Senate acts promptly on the legislation, because the FDA commissioner has warned us that an outbreak like this will happen again if we don’t clarify oversight.”
Alexander said: “This bill will help prevent Tennessee families from living through another nightmare like last year’s tragic meningitis outbreak, which has killed 16 Tennesseans and sickened so many others. I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who’s on the flagpole—who’s in charge—of overseeing their compounding practices.”
Today’s agreement was announced was by Alexander and Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.). The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.
Further, compounders who wish can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law. Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.
The legislation will include the Drug Supply Chain Security Act, legislation passed unanimously by the Senate HELPCommittee, to replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some 4 billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers.
Last November, when the Senate HELP Committee held its first hearing on the deadly meningitis outbreak, Alexander called for a new model of oversight of sterile compounding pharmacies.
A recently released report from the nonpartisan Government Accountability Office (GAO) confirmed that legislation is needed to clarify the FDA’s oversight of large-scale drug compounders. The report authors concluded that there are “gaps in oversight” and that “it is essential to have clear roles for FDA and states in regulation and oversight of drug compounding.”
