To Help Avoid Repeat of Deadly Meningitis Outbreak, Senate Sends Alexander Compounding Legislation to President
Posted on November 18, 2013
Agreement reached by House and Senate will make sterile compounded drugs safer by clarifying oversight of compounding pharmacies
“I worked with other members of Congress for a year to find a solution that would help prevent a repeat of the tragic meningitis outbreak that has killed 16 Tennesseans and made so many others so sick. Those Tennesseans deserve this bill, which will 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.” – Lamar Alexander
WASHINGTON, Nov. 18– Senator Lamar Alexander (R-Tenn.), the senior Republican on the Senate health committee, today announced that the Senate has passed and sent to the president’s desk a legislative agreement he helped reach between House and Senate health committees to make injections of compounded sterile drugs safer.
Alexander said: “I worked with others members of Congress for a year to find a solution that would help prevent a repeat of the tragic meningitis outbreak that has killed 16 Tennesseans and made so many others so sick. Those Tennesseans deserve this bill, which will 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.”
He added: “FDA Commissioner Margaret Hamburg told us last year that if Congress failed to act, a crisis like the meningitis outbreak was ‘a matter of when, not if.’”
Alexander said the Senate was at the same time sending legislation to the president to track and trace the more than 4 billion prescriptions that are written in America every year to help ensure their safety. “Congress has been working on this for more than a decade,” Alexander said. “This is a vitally important piece of legislation that affects almost every American.”
Today’s bill represented an agreement announced 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.) and passed by the House on Sept. 28. The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.
The legislation is supported by the Tennessee Pharmacists’ Association, who have said: "We believe this compromise proposal offers an effective approach to address complex issues surrounding compounded medications by having the Food and Drug Administration (FDA) focus on entities that are compounding outside the scope of traditional pharmacy compounding while leaving traditional pharmacy compounding under the oversight of state boards of pharmacy."
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.
One year ago, the meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center alerted the nation that providers and patients need sources of safe compounded drugs. Following the outbreak, a bipartisan group of HELP Committee senators— led by Chairman Harkin, Ranking Member Alexander, Sen. Pat Roberts (R-Kan.), and Sen. Al Franken (D-Minn.)—developed legislation to help ensure that quality compounded drugs are available to patients who need them.
The legislation passed by the Senate today distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
It also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.
The bill also includes legislation passed unanimously by the Senate health committee that would 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 consumers can receive drugs that are stolen, counterfeit, or ineffective.
This legislation requires the entire drug supply chain—including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers—to pass along transaction information, history, and statements, as applicable, when there is a change of ownership. The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago with the passage of The Prescription Drug Marketing Act.