HELP Committee Members Call for Senate Passage of Drug Quality and Security Act

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 applauded the House 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 bicameral, bipartisan effort to address these drug safety and security issues.

“With the passage of this drug safety bill by the House today, we have a clear example of what Congress can accomplish when both sides come together,” said Chairman Harkin. “Americans deserve to know that their medications are safe, and by improving oversight of high-risk drug compounding facilities, we can make that a reality. The bill also increases the security of the pharmaceutical supply chain by implementing an unprecedented tracing system to track prescription drugs from manufacturing to distribution. I am hopeful that the Senate will take up the bill as quickly as possible so that this important measure can be sent to the President's desk to be signed into law."

“This is a big step toward preventing another nightmare for Tennesseans like last year’s tragic meningitis outbreak, which the FDA commissioner tells us will happen again if we don’t fix the uncertainty over who’s in charge of compounding facilities. The House has passed our agreement to 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. I urge the Senate to act swiftly and send this bill to the president to sign,” said Ranking Member Alexander.

“Patients in Minnesota and across the country have to trust that the medications they’re receiving are safe,” said Sen. Franken. “But sadly that’s not always the case. I’ve fought hard during the past year to get critical oversight in place over entities that are essentially drug manufacturers so that patients can be guaranteed safe drugs. And after all that work, I’m proud that we were able to produce a commonsense, bipartisan piece of legislation. This bipartisan compromise will be an important step toward preventing deadly, drug-related outbreaks like the one that happened last year, and I’m very pleased that the House was able to come together and pass it.”

“This legislation protects traditional pharmacy while giving patients more confidence in the safety and quality of compounded drugs,” Sen. Roberts said. “I applaud the bill’s swift passage in the House and urge my Senate colleagues to pass this bill without further delay because as we saw with the recent meningitis outbreak, lives are at stake.”

“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. “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.  Now that the House has passed this bill, we will work to get it passed quickly in the Senate and sent to the President for his signature.”

“I applaud the House for their swift action in passing this bipartisan legislation on behalf of our nation’s patients,” said Sen. Burr.  “This 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 urge my colleagues in the Senate to follow suit and take up the bill as soon as possible.”

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 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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