Senate HELP Committee Releases Updated Bill to Secure Drug Supply Chain from Counterfeiting and Theft
Colorado U.S. Senator Michael Bennet and a bipartisan coalition of senators on the U.S. Senate committee overseeing health policy today urged Senate action on their bill to protect the nation’s drug supply chain for the nearly 4 billion prescriptions filled annually by establishing a uniform, national prescription drug-tracing framework. The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago with the passage of The Prescription Drug Marketing Act.
The senators released an update of the bill that passed unanimously out of the Senate Health, Education, Labor and Pensions (HELP) Committee in May— the update is informed by ongoing feedback from pharmacists, physicians, patients, and consumer groups to improve the effectiveness of the bill. [More details here in a section-by-section, FAQ, and summary of updates.]
“When Coloradans head to their local pharmacies, the last thing they need to be worried about is the safety of the medicine they buy. Right now, we know more from the barcode on a gallon of milk than we do from the barcode on a bottle of bills,” Bennet said. “This is a commonsense bill that will establish a national track-and-trace system and will restore confidence to our nation’s families that our drug supply is safe and effective.”
The committee has worked for more than a year to gain consensus and develop a national, uniform, electronic prescription drug tracing system that will, within a decade, result in electronic, interoperable unit level tracing. This bill requires the entire drug supply chain—including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers—to pass along transaction information, history, and statements, as applicable, when there is a change of ownership.
The Pharmaceutical Quality, Security, and Accountability Act, which was introduced by Chairman Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R–Tenn.), includes the Pharmaceutical Compounding Quality and Accountability Act (Title I), a bill championed by Sens. Pat Roberts (R-Kan.) and Al Franken (D-Minn.), and Bennet’s Drug Supply Chain Security Act (Title II), which he introduced with Richard Burr (R-N.C.).
Title I of the bill makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the U.S. Food and Drug Administration (FDA).
Title II 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 4 billion prescriptions per year in the United States, which means consumers can receive drugs that are stolen, counterfeit, or ineffective.