The U.S. Senate on Monday passed the Drug Quality and Security Act, capping well over a year of behind-the-scenes work by Sen. Richard Burr.
Burr, a Republican from Winston-Salem, and Democratic Sen. Michael Bennet of Colorado were the lead authors of a provision in the law that will establish a system to track prescription drugs from the time they’re manufactured to when they’re sold at a drugstore, making recalls easier.
Lawmakers say it’s the first major improvement in securing the prescription drug supply chain in 25 years.
The law also will improve oversight and clarify laws that protect the safety of compounded drugs. It now goes to President Barack Obama for his signature.
“America’s patients expect and deserve the peace of mind that medicines they take are safe and effective,” Burr said on the Senate floor last week.
The bill was a rare show of bipartisan collaboration.
Burr in his speech recognized Bennet as a strong partner.
“We were told this couldn’t be done. We were told this is too difficult,” Burr said. “But for a year and a half we have tackled this objective.”
Bennet returned the compliment in his floor speech.
“I want to acknowledge the relentless – and that’s the only way to describe it – the relentless effort of Senator Richard Burr. He’s been a true advocate and an outstanding partner with me and my staff,” he said. “His tireless efforts and that of his staff helped us move this legislation into law.”
Staffers said the two senators and their staff worked for months with business and consumer groups to reach agreement. Staffers said Burr was a driving force when there was pressure to pass the bill without the part to trace prescription medications.
Business, consumer and health groups cheered the passage.
“The counterfeiting of prescription drugs is on the rise within the United States but oftentimes goes unnoticed or unreported, leaving many Americans unaware of this problem. In fact, some experts have cited the counterfeiting of these medicines as even more lucrative than the trafficking of illegal drugs like heroin and cocaine,” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said in a statement.
“This act will improve the security of the finished drug supply chain and reduce the impact of the patchwork of state laws related to the pedigree requirements for drug distribution,” he added.
The compounding drug part of the legislation is aimed at preventing a public health crisis like one in 2012 that was caused by contaminated compounded drugs from the New England Compounding Center. Sixty-four people died nationwide, including a woman in Denton, about 90 miles west of Raleigh. Hundreds of others got sick from contaminated steroids distributed from the center.