Bennet's Bipartisan Track-and-Trace Bill Included in Proposal
Colorado U.S. Senator Michael Bennet joined a bipartisan group of Senate Health, Education, Labor, and Pensions (HELP) Committee senators to announce that they have reached an agreement with health policy leaders in the House of Representatives on a bill to track all prescription drugs from the point they are manufactured to the drug store and to provide better oversight of compounding pharmacies.
The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address these drug safety and security issues. The drug supply chain security provisions are based off of Bennet’s Drug Supply Chain Security Act he introduced with Senator Richard Burr (R-NC) in May after working to find consensus over the last two years. 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.
In addition to Senator Bennet, the bill was introduced by HELP Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and Senators Al Franken (D-MN), Pat Roberts (R-KS), and Burr.
“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,” Senator Michael 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.”
Drug Supply Chain Security
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. 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.
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.