Bipartisan Group of HELP Committee Senators Introduce Legislation to Address High-Risk Drug Compounding Practices and Secure the Pharmaceutical Supply Chain

WASHINGTON, D.C.—A bipartisan group of Senate Health, Education, Labor, and Pensions (HELP) Committee senators—Chairman Tom Harkin (D-IA), 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)—today announced that they have reached agreement with House health policy leaders on legislation to help ensure the safety of compounded drugs and to track all prescription drugs from the time they are manufactured to the moment they are picked up at the drugstore.  This draft reflects a bicameral, bipartisan effort to address these drug safety and security issues.

“Plain and simple, this legislation will help ensure that providers and their patients have access to high-quality compounded drugs,” said Chairman Harkin.  “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,” Ranking Member Alexander said. “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.”  

“Patients in Minnesota and across the country need to be able to trust that the medications they receive will make them better and not worse,” said Sen. Franken. “Unfortunately, that’s not always the case. Over the past several months, I have worked hard to ensure that important and necessary oversight of entities that are essentially drug manufacturers exists so patients and their families can trust that the medicines they take are safe. I'm very pleased that we were able to come together and produce bipartisan legislation that will go a long way towards preventing another tragic outbreak.”

“I became involved in this issue following the unlawful acts of Kansas City pharmacist Robert Courtney over a decade ago,” Sen. Roberts said. “Following the tragedy of the meningitis outbreak from a Massachusetts compounding pharmacy, the Senate has made a concerted effort to prevent tragedies like these from ever occurring again. This legislation protects traditional pharmacy while giving patients more confidence in the quality and safety of their compounded drugs. I look forward to additional feedback on this draft from stakeholders who have also been working so hard on this effort.”

“If fruit growers in Colorado can track a peach from the tree to the grocery store, we should be able to monitor prescription drugs in a similar way,” Sen. Bennet said. “Coloradans have reasonable expectations that the medicines they receive from pharmacies and drug stores are safe and effective. Whether it is through a stronger supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from any potential health risks.”

“Securing our nation's drug supply chain is critical to the health and safety of the American people," said Sen. Burr. “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.”

Title I 

One year ago, the meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center alerted the nation that providers and patients need sources of safe compounded drugs.  Following the outbreak, a bipartisan group of HELP Committee Senators— led by Chairman Harkin, Ranking Member Alexander, Sen. Franken, and Sen. Roberts—developed legislation to help ensure that quality compounded drugs are available to patients who need them.

Among other highlights, the legislation:

• Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
• Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  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 legislation will give providers and patients the option of purchasing product from outsourcing facilities that comply with FDA quality standards.
• Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
• Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.

Title II

Chairman Harkin, Ranking Member Alexander, Sen. Bennet, and Sen. Burr have developed track and trace legislation that improves patient safety by replacing today’s patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.  The last comprehensive effort to establish safeguards for the drug distribution supply chain was twenty-five years ago.  This bipartisan, bicameral draft is the result of several years of work to address the growing problem of pharmaceutical theft, counterfeiting, and diversion.  

Among other highlights, the legislation:

• Develops a workable pathway to unit-level tracing in a decade. Over the course of seven years, the major sectors of the pharmaceutical supply chain, such as manufacturers, repackagers, wholesale distributors, and dispensers will all be passing and holding onto key information about each drug’s distribution history.  Within ten years, supply chain stakeholders will participate in electronic, interoperable product tracing.
• Strengthens licensure requirements for wholesale distributors and third-party logistics providers.  Wholesale distributors will have higher standards for their licenses nationwide, and third-party logistics providers will be recognized for the first time as a part of the drug supply chain. FDA will also keep a database of wholesalers that will be available to the public through the FDA’s website, allowing consumers and members of the drug supply chain to identify appropriately licensed wholesalers.
• Establishes nationwide drug serial numbers.  Four years after the date of enactment, manufacturers will serialize drugs in a consistent way across the industry.  This will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.   
   

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