Senate Health Policy Leaders Hail Passage of Bipartisan Legislation to Improve Safety of Compounded Drugs, Track All Prescription Drugs; Bill Now Heads to the President’s Desk

WASHINGTON, D.C.—Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and HELP Committee members Senator Al Franken (D-MN), Senator Pat Roberts (R-KS), Senator Michael Bennet (D-CO), and Senator Richard Burr (R-NC) today hailed Senate passage of 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.  The Drug Quality and Security Act reflects a bipartisan, bicameral effort to address these drug safety and security issues.  It is aimed at helping prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center and securing the pharmaceutical supply chain. The bill has now cleared both houses of Congress and will go on to the President to be signed into law.

“Just over one year ago, a widespread fungal meningitis outbreak brought attention to the legal and regulatory gaps that allowed owners and managers at the New England Compounding Center to disregard basic procedures to ensure that the products they were manufacturing were sterile.  This gross negligence had heartbreaking consequences for families nationwide,” Harkin said. “And the contamination at the NECC was not an isolated incident: over the last decade, patients have suffered a range of grievous—even fatal—infections as a result of compounded drugs that were contaminated or improperly formulated.”

“This bipartisan bill represents a monumental step forward for drug safety and is a testament to what Congress can achieve when Democrats and Republicans work together,” Harkin continued. “This legislation will improve the safety of compounded drugs as well as establish an unprecedented tracing system that will, for the first time ever, track prescription drugs from manufacturing to distribution, thereby thwarting drug counterfeiters. Americans must have the confidence that their drugs— whether obtained at a hospital, at a doctor’s office, or at the pharmacy counter—are safe, and that is exactly what this bill does.”

Alexander said: “We have worked for a year to find a solution that would help prevent a repeat of the tragic meningitis outbreak that has killed 16 Tennesseans and made so many others so sick. Those Tennesseans deserve this bill, which will make it clear exactly who is in charge of overseeing each compounding facility, so there will be no questions about who’s on the flagpole.

“Patients in Minnesota and around the country should be able to trust that the medications they are taking are safe, but we’ve seen that hasn’t always happened. But I’m pleased that with the passage of this bipartisan legislation, we’ve taken an important step forward in helping give patients a little more peace of mind about their prescriptions,” Franken said. “While we still have more work to do, the passage of this legislation marks real progress in preventing another outbreak like the one that happened last year.”

Roberts added, “I became involved in this issue after a Kansas City pharmacist risked thousands of patient lives with illegal practices. After the deadly meningitis outbreak caused by contaminated medication, a bipartisan, bicameral group of lawmakers came together with industry stakeholders and made a concerted effort to prevent tragedies like these from ever occurring again. This legislation protects traditional pharmacies, while giving patients more confidence in the quality and safety of their compounded drugs.”

“After years of bipartisan work in Congress and feedback from business and stakeholders, we’re glad that this bill has passed and is on its way to the President’s desk for his signature,” Bennet said. “We know more from a barcode on a gallon of milk than on a bottle of prescription drugs, which could mean the difference between life and death. Whether it is through a stronger drug supply chain that strengthens our national security 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.”

Burr said: “After years of hard work, I am very proud to see this bill sent to the President to be signed into law.  This bipartisan bill reflects a collaborative effort to produce balanced legislation that appropriately responds to the tragic meningitis outbreak over the past year and proactively puts in place uniform, workable standards that will provide stakeholders with critical regulatory certainty and give patients renewed confidence in the safety and security of our nation’s pharmaceutical drug supply chain.  I want to thank my colleagues on both sides of the aisle for their hard work and steadfast commitment to seeing this process through to the end.”

A broad range of stakeholders, including the American Society of Health-System Pharmacists, the Pew Charitable Trusts, the U.S. Chamber of Commerce, the National Community Pharmacists Association, the Federation of American Hospitals, Premier Healthcare Alliance, the American Medical Student Association, the American Public Health Association, the Annie Appleseed Foundation, the Association of State and Territorial Health Officials, the Center for Science and Democracy, the Union of Concerned Scientists, the Center for Medical Consumers, Community Catalyst, the Connecticut Center for Patient Safety, the National Association of County and City Health Officials, the Ovarian Cancer National Alliance, Trust for America’s Health, the Healthcare Distribution Management Association, the Pharmaceutical Distribution Security Alliance, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, PharMEDium, the Biotechnology Industry Organization, the National Association of Chain Drug Stores, Pfizer, UPS, and Richie’s Specialty Pharmacy endorsed the Drug Quality and Security Act. Excerpts from their endorsements can be seen here.

A summary of the bill follows.

Title I

One year ago, the meningitis outbreak tied to 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 and providers 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 products 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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