Today, U.S. Sen. Al Franken (D-Minn.) said that his bipartisan bill to help prevent future deaths related to contaminated medications has cleared a key hurdle with the news that the legislation is now being backed by a strong, bipartisan coalition in the House of Representatives.
Sen. Franken and a bipartisan group of his Senate Health Committee colleagues reached an agreement with House health policy leaders on legislation to help ensure the safety of drug compounding, which includes the making, mixing, diluting, or combining of drugs for individual patients, and the tracking of all prescription drugs from the time they are manufactured to the moment they are picked up at the drugstore. The bill would clarify the oversight responsibilities of the Food and Drug Administration over large-volume sterile facilities--called outsourcing facilities--and by holding these facilities to high quality standards.
"Patients in Minnesota and across the country need to be able to trust that the medications they receive are safe," said Sen. Franken. "Unfortunately, that's not always the case. Over the past several months, I've worked hard to get critical oversight in place over entities that are essentially drug manufacturers so patients are guaranteed safe drugs. I'm very pleased that we were able to come together and produce bipartisan legislation that will go a long way towards preventing another tragic outbreak."
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 Senate Health Committee colleagues--led by Chairman Tom Harkin (D-Iowa), Ranking Member Lamar Alexander (R-Tenn.), Sen. Franken, and Sen. Pat Roberts (R-Kan.)--developed legislation to help ensure that quality compounded drugs are available to patients who need them.
Sen. Franken's legislation would also improve patient safety by replacing today's patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country. The last comprehensive effort to establish safeguards for the drug distribution supply chain was twenty-five years ago.