Committee releases updated legislation to clarify oversight of compounding manufacturers and secure the drug supply chain from counterfeiting and theft
WASHINGTON D.C., July 25 – A bipartisan coalition of senators on the U.S. Senate committee overseeing health policy today urged Senate action on their legislation to help prevent another compounding crisis like the 2012 fungal meningitis outbreak that has led to 61 deaths and 749 illnesses, as well as 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 senators released an update of the legislation 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.]
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), legislation championed by Sens. Pat Roberts (R-Kan.) and Al Franken (D-Minn.), and the Drug Supply Chain Security Act (Title II), legislation championed by Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.).
Title I of the billmakes 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.
Harkin said: “This bill will benefit virtually every American consumer by improving the safety of drugs and medications,” Harkin said. “The Pharmaceutical Quality, Security and Accountability Act will help protect the public from unsafe compounded products and clarify FDA authority over high-risk compounding practices. A bipartisan Senate HELP Committee report released earlier this year showed that large-scale drug compounders like the New England Compounding Center—the culprit of the fungal meningitis outbreak—continue to pose a grave risk to public health. Congress must take action to improve the safety of compounded drugs and prevent the next public health crisis.
“In addition to improving the safety of compounded drugs, this bill includes provisions—reflecting more than two years of bipartisan work—to dramatically bolster the integrity and security of our prescription drug distribution system,” Harkin added. “Tracking where drugs have been at every step of the way, from the manufacturer to the pharmacy, will help ensure that consumers receive drugs that are legitimate and safe. This legislation reflects the input of a wide variety of stakeholders and should be passed by Congress as soon as possible.”
Alexander said: “Our goal with this bill is to help put an end to health crises resulting from poorly regulated compounding manufacturers and make it clear who is on the flagpole—who is in charge and accountable for oversight of these compounding manufacturers and who is accountable for pharmacies. The updates to the legislation reflect many hours of working with pharmacists, physicians, patients, and consumer groups to improve the legislation.”
Roberts said: “For me, this bill is about saving lives, plain and simple. The most recent compounding outbreak resulted in 61 deaths. More than 700 people continue to suffer from tainted compounded medicine. We must find reasonable ways to prevent further death or illness due to confusion over who has oversight of compounding pharmacies. We are working with all groups to make this the best bill possible before it heads to the floor. We need compounded medicines in our arsenal, but it’s in everyone’s interests – pharmacists, doctors and patients alike --to ensure they are safe.”
Franken said: “Patients need to be able to trust that the medications they’re getting from their pharmacies are safe. Sadly, that’s not always the case. I have worked hard over the past several months on our legislation to make sure that the necessary oversight exists so patients and their families can trust that the prescription drugs they take will make them better and not worse."
Bennet said:“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. 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.”
Burr said: “Securing our nation’s drug supply chain is critical to the health and safety of the American people. The American people deserve the peace of mind to know that the medicines they take are safe and effective. This bill establishes a uniform system that improves the security and safety of drugs for consumers.”
This bill includes the following improvements: clarifies that traditional pharmacies may compound a drug for a doctor to use in the office; makes clear standards for which drugs FDA can determine are too complex to be compounded; requires compounding manufacturers to identify their compounded drugs when they register with FDA; provides greater transparency by directing FDA to list the names of compounding manufacturers and the states where they are located; and clarifies the steps that traditional pharmacies must take when compounding a copy of an FDA-approved drug in shortages.
The HELP Committee’s work on legislation to improve the safety of compounded drugs came in response to a fall 2012 fungal meningitis outbreak that to date has caused 749 illnesses and 61 deaths. The meningitis outbreak was directly traced to contamination in steroid injections produced at a large-scale compounder, the Massachusetts-based New England Compounding Center (NECC). Earlier this year, a bipartisan investigation by the Committee clearly documented the ongoing risk to the public health from large-scale drug compounding companies that is addressed by the bill.
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 legislation 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 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.