Democratic and Republican Health Policy Leaders Applaud House Passage of Bill to Address High-Risk Drug Compounding Practices and Secure the Pharmaceutical Supply Chain
WASHINGTON, D.C.—A bipartisan group of Senate Health, Education, Labor, and Pensions (HELP) Committee senators—Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), Senator Al Franken (D-MN), Senator Pat Roberts (R-KS), Senator Michael Bennet (D-CO), and Senator Richard Burr (R-NC)—today applauded the House passage of legislation to help ensure the safety of compounded drugs and to track all prescription drugs from the time they are manufactured to the moment they are picked up at the drugstore. The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address these drug safety and security issues.
“With the passage of this drug safety bill by the House today, we have a clear example of what Congress can accomplish when both sides come together,” said Chairman Harkin. “Americans deserve to know that their medications are safe, and by improving oversight of high-risk drug compounding facilities, we can make that a reality. The bill also increases the security of the pharmaceutical supply chain by implementing an unprecedented tracing system to track prescription drugs from manufacturing to distribution. I am hopeful that the Senate will take up the bill as quickly as possible so that this important measure can be sent to the President's desk to be signed into law."
“This is a big step toward preventing another nightmare for Tennesseans like last year’s tragic meningitis outbreak, which the FDA commissioner tells us will happen again if we don’t fix the uncertainty over who’s in charge of compounding facilities. The House has passed our agreement 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. I urge the Senate to act swiftly and send this bill to the president to sign,” said Ranking Member Alexander.
“Patients in Minnesota and across the country have to trust that the medications they’re receiving are safe,” said Sen. Franken. “But sadly that’s not always the case. I’ve fought hard during the past year to get critical oversight in place over entities that are essentially drug manufacturers so that patients can be guaranteed safe drugs. And after all that work, I’m proud that we were able to produce a commonsense, bipartisan piece of legislation. This bipartisan compromise will be an important step toward preventing deadly, drug-related outbreaks like the one that happened last year, and I’m very pleased that the House was able to come together and pass it.”
“This legislation protects traditional pharmacy while giving patients more confidence in the safety and quality of compounded drugs,” Sen. Roberts said. “I applaud the bill’s swift passage in the House and urge my Senate colleagues to pass this bill without further delay because as we saw with the recent meningitis outbreak, lives are at stake.”
“If fruit growers in Colorado can track a peach from the tree to the grocery store, we should be able to monitor prescription drugs in a similar way,” Sen. Bennet said. “Whether it is through a stronger supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from any potential health risks. Now that the House has passed this bill, we will work to get it passed quickly in the Senate and sent to the President for his signature.”
“I applaud the House for their swift action in passing this bipartisan legislation on behalf of our nation’s patients,” said Sen. Burr. “This bill reflects a collaborative effort to produce balanced legislation that appropriately responds to the tragic meningitis outbreak over the past year and proactively puts in place uniform, workable standards that will provide stakeholders with critical regulatory certainty and give patients renewed confidence in the safety and security of our nation’s pharmaceutical drug supply chain. I urge my colleagues in the Senate to follow suit and take up the bill as soon as possible.”
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. Franken, and Sen. Roberts—developed legislation to help ensure that quality compounded drugs are available to patients who need them.
Among other highlights, the legislation:
Chairman Harkin, Ranking Member Alexander, Sen. Bennet, and Sen. Burr have developed track and trace legislation that improves 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. This bipartisan, bicameral draft is the result of several years of work to address the growing problem of pharmaceutical theft, counterfeiting, and diversion.
Among other highlights, the legislation: