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Harkin, Alexander: One Year Anniversary of Major HELP Committee Legislation to Better Secure the Nation’s Drug Supply

WASHINGTON, D.C.—This week marks the one-year anniversary of the landmark Drug Quality and Security Act (DQSA), which Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Ranking Member Lamar Alexander (R-TN) introduced and led to passage in the Senate. The DQSA significantly improved the safety of our nation’s drug supply by clarifying federal law regarding pharmaceutical compounding and by creating a new framework for securely tracking prescription drugs from the manufacturer to a patient’s pharmacy. The President signed the bill into law on November 27, 2013. 

“The DQSA exemplifies the meaningful bipartisan work of the Senate HELP Committee throughout this Congress to pass critical measures that support and protect public health,” Harkin said. “Chief among these accomplishments is the Drug Quality and Security Act, which represented a strong and thoughtful response to the tragic 2012 meningitis outbreak tied to compounded drugs. The legislation dramatically improved the oversight and safety of compounded drugs, and also established an unprecedented framework to securely track prescription drugs from the drug manufacturer to a patient’s pharmacy.”

“The Senate HELP Committee’s record of accomplishments during this Congress is quite remarkable with 21 bipartisan bills now enacted to support and protect public health. The Drug Quality and Security Act is one of our most important pieces of legislation that will positively impact public health and improve the lives of Americans,” Harkin added.

Alexander said: “This legislation was a critical first step to helping prevent a repeat of the tragic meningitis outbreak that killed 16 Tennesseans and made so many others sick, as well as a critical step in preventing counterfeit or tainted drugs from reaching patients. Good progress has been made in the past year, but there is still important work to do to ensure the safety, supply and clear oversight of our drugs.”

The DQSA clarified federal law regarding pharmacy compounding and applied a uniform standard nationwide. Compounders who wish to practice outside the bounds of traditional pharmacy practice now can register with the Food and Drug Administration (FDA) as outsourcing facilities, but those who choose to remain traditional pharmacies continue to be regulated primarily by state boards of pharmacy. FDA has taken several significant steps to implement the new law, including through the release of three guidance documents just last week.

The second title of the DQSA replaced a patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to a patient’s pharmacy. Before the DQSA, there was no system for tracking the drugs that make up some four billion prescriptions per year in the United States.  The new framework will help keep stolen or counterfeit drugs out of the supply chain before they ever reach consumers.