Senate Passes Most Comprehensive Drug Safety Bill in 25 Years

Drug Quality and Security Act Now Heads to President's Desk

Today the Senate passed a bipartisan, bicameral bill that represents the most comprehensive effort to establish safeguards for the drug distribution supply chain in the last quarter-century. The Drug Quality and Security Act would track all prescription drugs from the time they are manufactured to the moment they are picked up at the drugstore and would improve the safety of compounded drugs. 

The drug supply chain security provisions included in the bill 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.

“After years of bipartisan work in Congress and feedback from businesses and patients, 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 we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death. Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

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, Woodymatters, 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.

“The Drug Quality and Security Act is a major step forward to better ensure that our prescription drug supply stays safe for patients. Over the next decade, we will move toward an interoperable electronic system that will help us sort through recalls faster and increase patient safety. This bill is the result of feedback and contributions from all sectors of business, and it gives community pharmacists the flexibility it needs, on behalf of Colorado families, to work more closely with its drug wholesalers and manufacturers.”
– David Lamb, owner, Good Day Pharmacies, with nine locations in Colorado

“We applaud the passage of the Drug Quality and Security Act, which establishes a uniform standard for electronically tracing pharmaceuticals through the entire supply chain. This landmark, bipartisan legislation is the result of years of hard work by lawmakers and the healthcare industry. We are confident that it will make the nation’s pharmaceutical supply chain, already the best in the world, stronger and more secure while ensuring that patients across the country continue to have access to safe medications.”
–Jake Kramer, McKesson Distribution Center Manager, Denver, Colorado

“Counterfeit and diverted medicines can have life or death consequences for patients.   As part of a commitment to protecting the well-being of patients, Amgen supports the most effective measures to prevent counterfeiting and diversion.

“We applaud Congress for all their work developing legislation that would implement a federal track and trace standard. This legislation provides a uniform standard that will help secure the downstream movement of medicines in the supply chain.  We look forward to continuing our work with regulators and supply chain partners to implement these standards in the interest of patient safety.”
–Martin VanTrieste, Senior Vice President of Quality Administration, Amgen

A summary of the bill can be found by clicking here.