Tuesday, December 1, 2015

House, Senate leaders craft legislation ensure safety of the nation's pharmaceutical supply chain

House and Senate committee leaders overseeing health policy announced an agreement on Wednesday for legislation to ensure the safety of compounded drugs and the nation's pharmaceutical supply chain.

The Drug Quality and Security Act follows a bipartisan, bicameral effort to improve drug safety and help to prevent a future public health crisis like the 2012 New England Compounding Center meningitis outbreak.

"Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding," Energy and Commerce Committee Chairman Rep. Fred Upton (R-Mich.) said. "This step will help us protect the health and safety of the American people. The leadership of Rep. Morgan Griffith (R-Va.), Rep. Bob Latta (R-Ohio), Health Subcommittee Chairman Joe Pitts (R-Pa.), and Oversight and Investigations Subcommittee Chairman Tim Murphy has been fundamental in achieving this bipartisan agreement (R-Pa.)."

"It has been nearly one year since the tragic, deadly fungal meningitis outbreak and I am pleased to be working with my colleagues in the Senate to send a bill to the president's desk, bringing this investigative and legislative effort to a successful conclusion soon. In light of the missed opportunities to prevent the outbreak, with this bill we say, 'never again.'"

The bill clarifies the current federal law in regards to pharmacy compounding and resolves the current patchwork federal regulations by applying a standard, uniform nationwide policy.

While compounders can register as outsourcing facilities under terms of the bill, those that remain traditional pharmacies will be regulated primarily by state boards of pharmacy as they are under current law.

Outsourcing facilities would become subject to oversight by the U.S. Food and Drug Administration, which will know who the outsourcers are and what they are making, as well as receive adverse event reports about compounded drugs and have the authority and resources to conduct risk-based inspections.

The bill will also replace the current state prescription drug tracing laws, replacing them with a new uniform framework for tracking drugs from the manufacturer to the pharmacy.