Drug Quality and Security Act includes Track-and-Trace Bill, Compounding Pharmacy Oversight
Colorado U.S. Senator Michael Bennet welcomed the Senate’s vote today to begin debate on a bipartisan bill to make pharmaceutical drugs safer for consumers by tracing them from the point they are manufactured to the pharmacy that sells them to consumers. It also raises standards for wholesale drug distributors, which will help ease drug shortages.
The bill, which also provides better oversight of compounding pharmacies, is based off of Bennet’s Drug Supply Chain Security Act, which he introduced in May after working to find bipartisan consensus over the last two and a half years. The Senate is expected to vote on final passage by the end of the week.
“Coloradans expect that we are already taking these basic commonsense steps to make sure their medicine is safe. Yet you can get more data from a barcode on a gallon of milk than you can from a bottle of aspirin two aisles over,” Bennet said. “This bill is the culmination of more than two years of bipartisan, bicameral work along with pharmacies, distributors, and prescription drug manufacturers. It will help us keep the prescription drug supply safe and keep our families healthy.”
The lack of a strong, uniform system to secure the supply chain has allowed criminals to exploit a number of vulnerabilities. Problems include drugs that are stolen, tainted, or diluted and sold back into the supply chain, counterfeit drugs, an inability to quickly recall tainted medicine, and drug shortages. All of these problems have led to serious health problems and driven up costs. Under the prescription drug security provisions of the bill, the FDA will know who has handled which drugs and when they handled them, preventing counterfeit or stolen pharmaceuticals from being sold back into the system and allowing the FDA to respond to recalls and shortages more quickly and efficiently.
The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address prescription drug safety and security issues. 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.