The House of Representatives passed the bipartisan Drug Quality and Security Act, H.R. 3204, sponsored by Energy and Commerce Committee Chairman Rep. Fred Upton (R-Mich.), on Saturday.
The legislation is meant to improve drug safety and aid in preventing a future public health crisis like the deadly 2012 meningitis outbreak that was tied to the New England Compounding Center, which was linked to 64 deaths and 750 cases in 20 states.
Upton worked closely with Ranking Member Rep. Henry A. Waxman (D-Calif.), Senate HELP Committee Chairman Sen. Tom Harkin (D-Iowa) and Ranking Member Sen. Lamar Alexander (R-Tenn.) 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,” Upton said. “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.'”
The legislation, which would protect traditional pharmacies and clarify the 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, was supported by dozens of leading national health and patient organizations.
Additionally, the legislation would create a uniform standard for drug supply chain security to protect against counterfeit drugs and eliminate government red tape.
The legislation would also help to prevent increases in drug prices, avoid additional drug shortages and eliminate hundreds of millions of dollars of duplicative government regulations.