WASHINGTON, D.C.—Today, after the U.S. Senate took a procedural vote to start debate on the Drug Quality and Security Act, Senator Tom Harkin (D-IA) said Congress was one step closer to passing the legislation. Harkin, as Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, worked on a bipartisan, bicameral basis to develop the legislation in the wake of the 2012 meningitis outbreak tied to the New England Compounding Center. The U.S. House approved the measure in September, so once approved by the Senate, it will go on to the President’s desk for signature.
“Just over a year ago, we were all shocked to learn of one of the worst public health crises this country has experienced in recent years: the meningitis outbreak that so far has claimed the lives of 64 Americans and sickened 751 patients in 20 states. This outbreak brought attention to the legal and regulatory gaps that allowed owners and managers at the New England Compounding Center to disregard basic safety procedures for safe, sterile products,” Harkin said. “Our strong, bipartisan proposal dramatically improves oversight of high-risk drug compounding facilities. The bill also increases the security of the pharmaceutical supply chain by implementing an unprecedented tracing system to track prescription drugs from manufacturing to distribution.
“These provisions are a clear example of what Congress can accomplish when both sides come together,” Harkin added. “Americans deserve to know that their medications are safe, and by enacting this legislation, we can help make that a reality. I urge my colleagues to support this bipartisan legislation, which will greatly improve the safety of drugs, whether compounded or manufactured.”
The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide. Compounders who wish to practice outside the bounds of traditional pharmacy practice 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.
In addition to Harkin, the legislation is sponsored by HELP Committee Ranking Member Lamar Alexander (R-TN), Senator Al Franken (D-MN), Senator Pat Roberts (R-KS), Senator Michael Bennet (D-CO), and Senator Richard Burr (R-NC). Additional information on the bill is available here.