Senate, House Health Policy Leaders Announce Bipartisan, Bicameral Legislation to Address High-Risk Drug Compounding Practices and Secure the Pharmaceutical Supply Chain

WASHINGTON, D.C. —Leaders from the Senate and House committees overseeing health policy today announced that they have reached an agreement on legislation to help ensure the safety of compounded drugs and our nation’s pharmaceutical supply chain. This legislation, the Drug Quality and Security Act, reflects a bipartisan, bicameral effort to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

“Plain and simple, this legislation will help ensure that providers and their patients have access to high-quality compounded drugs,” said Senate HELP Committee Chairman Tom Harkin (D-IA).  “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards.  This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.”

“This bill will help prevent Tennessee families from living through another nightmare like last year’s tragic meningitis outbreak, which has killed 16 Tennesseans and sickened so many others. The FDA commissioner has warned us that an outbreak like this will happen again if we don’t clarify oversight, so I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who’s on the flagpole—who’s in charge—of overseeing their compounding practices,” said Senate HELP Committee Ranking Member Lamar Alexander (R-TN).

“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.  This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI). “The leadership of Rep. Morgan Griffith, Rep. Bob Latta, Health Subcommittee Chairman Joe Pitts, and Oversight and Investigations Subcommittee Chairman Tim Murphy has been fundamental in achieving this bipartisan agreement. 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.’”

“This legislation is a major stride toward the goal of ensuring the quality and safety of the medicines Americans rely upon every day," said Energy and Commerce Committee Ranking Member Henry A. Waxman (D-CA).  "The bill will correct the constitutional defect in FDA’s drug compounding statute that has wreaked havoc on the Agency’s ability to effectively enforce the law for years.  It will also give FDA the opportunity to have broad oversight of a new category of large compounding pharmacies.  This is undoubtedly a step forward for public health.  Further, we have developed a uniform system for tracking and tracing drugs to prevent counterfeits from entering the supply chain that maintains the strengths of the groundbreaking California system. I want to acknowledge the contributions of Reps. Frank Pallone, John Dingell, Diana DeGette, Gene Green, Jim Matheson, and former Rep., now Senator, Ed Markey to this bipartisan effort."

The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

Further, compounders who wish can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law.  Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections. 

The second title of the bill would replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers.

A recently-released report from the nonpartisan Government Accountability Office (GAO) confirmed that legislation is needed to clarify the U.S. Food and Drug Administration’s (FDA) oversight of large-scale drug compounders. The nonpartisan office wrote that “this lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” posing a grave threat to public health.