Legislation is the Product of Breakthrough Bipartisan, Bicameral Agreement to Ensure Deadly Meningitis Outbreak is Never Repeated
WASHINGTON, DC – The House of Representatives today passed H.R. 3204, the Drug Quality and Security Act, by a voice vote. The legislation, sponsored by Energy and Commerce Committee Chairman Fred Upton (R-MI), is the product of a thoughtful, bipartisan, bicameral effort to improve drug safety and help prevent a future public health crisis like the 2012 deadly meningitis outbreak tied to the New England Compounding Center (NECC). Energy and Commerce Committee leaders voiced their support of this legislation. Upton worked closely with committee Ranking Member Rep. Henry A. Waxman (D-CA), and Senate HELP Committee Chairman Sen. Tom Harkin (D-IA) and Ranking Member Sen. Lamar Alexander (R-TN) in achieving the agreement.
“I am proud to say that this piece of legislation is a product of true bipartisan and bicameral work. The Senate and the House, Republicans and Democrats came together to produce a bill that will protect American patients by ensuring they receive safe drugs,” said Chairman Upton. “It is because of our collaborative and tireless efforts that we are near the resolution of last year’s deadly outbreak. To all the families who have lost loved ones and to those who are still suffering today, with this bill we say ‘never again.’”
“This past year, a meningitis outbreak claimed 16 lives in Tennessee and 64 lives across the nation, and plagued hundreds of Americans,” said Energy and Commerce Committee Vice Chairman Marsha Blackburn (R-TN). “The cases stemmed from contaminated compounded drugs manufactured in some cases without the consent of the FDA. Traditional compounding is critical for patient needs and this legislation ensures millions of our most vulnerable relatives, friends, and neighbors continue to have safe access to essential and lifesaving medication. As a result of our investigation at Energy and Commerce, the bipartisan passage of H.R. 3204 will ensure necessary steps are identified to prevent a tragic outbreak from happening again.”
“The Drug Quality and Security Act is a first step at clarifying current law,” said Rep. Morgan Griffith (R-VA). “It eliminates perceived confusion that existed as a result of court decisions on advertising related to compounding drugs and adopts the notification provisions that were in the Griffith-Green-DeGette Compounding Clarity Act. The Drug Quality and Security Act leaves a large portion of existing law intact. It also leaves many areas of practice where clarification may still be needed, particularly as it relates to office use, repackaging, and nuclear pharmacies. Along with my colleagues, I will continue working to oversee the FDA’s interpretation and implementation of this law.”
“I applaud Chairman Upton for his work on this bill, and I’m very pleased to see that H.R. 1919, a bill that I introduced to strengthen and secure our nation’s pharmaceutical distribution supply chain, was included in this overall legislative package,” said Rep. Bob Latta (R-OH). “I am proud to support H.R. 3204, which makes improvements to the current supply chain and ensures greater patient safety for all Americans.”
“This legislation would address two important issues affecting the quality and security of America’s drug supply,” said Health Subcommittee Chairman Joe Pitts (R-PA). “First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year’s nationwide meningitis outbreak – one of the largest public health crises in recent memory. Second, the bill would strengthen the prescription drug supply chain in order to protect American families against counterfeit drugs.”
“With the passage of this bill, the FDA will have the authority it needs, but we have to also make sure that they have the fortitude to take action on any compounding pharmacy that they see not up to the high level of standards the FDA sets, that all citizens expect,” said Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA). “The Drug Quality and Security Act will end these problems, we hope, end these inspection holidays, and reassure the American public that these medications, wherever they are manufactured, and most by compounding pharmacies, who do a superb job of maintaining sterile conditions, but in all cases the FDA will have the authority to make sure they have the inspections and they have the team that can go in there and take solid action when these centers do not adhere to those high standards.”
“Since over 60 American lives were lost, and the excellent investigative work of the Subcommittee on Oversight and Investigations, I have been disturbed that not one person at FDA has been held accountable for their failure to use existing authorities or informing the State of what they knew,” said Vice Chairman of the Health and Oversight and Investigations Subcommittees Michael C. Burgess, M.D. (R-TX). “I hope the passage of the Drug Quality and Security Act will usher in a new day of accountability.”
Dozens of leading national health and patient organizations have also voiced their support for this breakthrough agreement to improve drug safety.
H.R. 3204 would protect traditional pharmacies and clarify FDA’s authority over the compounding of human drugs while requiring the agency to engage and coordinate with states to ensure the safety of compounded drugs. To date, the CDC has linked 64 deaths and 750 cases in 20 states to contaminated drugs from NECC.
This legislation would also create a uniform national standard for drug supply chain security to protect Americans against counterfeit drugs while eliminating needless government red tape. It would help prevent increases in drug prices, avoid additional drug shortages and eliminate hundreds of millions of dollars worth of duplicative government regulations.
The complete text of the bill is online here.