House Energy and Commerce Committee Chairman Fred Upton (R-MI) today introduced H.R. 3204, the Drug Quality and Security Act, the result of a 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).
"Today's introduction of this important, bipartisan legislation in the House is a critical milestone to protect the health and safety of the American people," said Chairman Upton. "Over the past year, my colleagues on both sides of the aisle on the committee and in the Senate have been relentless in their pursuit of the facts behind last year's deadly meningitis outbreak and working to prevent any such tragedy from happening again. In strengthening the drug supply chain, we eliminate costly red tape and open up opportunity for growth and job creation. Michigan has been the hardest hit by the meningitis outbreak, and the sad truth is it could have been stopped. To all the families who have lost loved ones and to those patients who continue to suffer, we say "never again.'"
H.R. 3204 would protect traditional pharmacies and clarify laws related to human drug compounding in response to the nationwide meningitis outbreak and would strengthen the prescription drug supply chain in order to protect American families against counterfeit 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.
This legislation would also 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.