WASHINGTON (Reuters) - Lawmakers failed to agree on a national plan for tracking medications, congressional staffers said on Monday, crimping efforts to protect the U.S. supply chain from the threat of counterfeit or stolen drugs.
After a last-ditch weekend attempt to hammer out the details of a plan, the Senate and House of Representatives conceded defeat in trying to include the measure in a “must-pass” funding bill for the U.S. Food and Drug Administration (FDA), said the staffers, who spoke on condition of anonymity.
The FDA funding bill is likely to be submitted for approval to President Barack Obama in early July, House leaders have said.
Earlier this year, counterfeit vials of cancer drug Avastin were sold to dozens of medical practices across the country, sparking new fears about the safety of the drug supply.
Regulators and healthcare companies have been talking about a “track and trace” system for nearly a decade, but cannot agree on what the system will look like or who will pay for it.
“It’s disappointing,” said one staffer, who was not authorized to speak on the record.
The staffer said some lawmakers may try to introduce the measure as a stand-alone bill later this year. But the legislation may have a hard time making it through a divided Congress.
The FDA has been pushing for a uniform plan that would track individual vials of medicine. But companies, distributors and pharmacies say it may be too expensive, and propose an alternative plan that would track much larger “lots” of drugs. They say their plan would pave the way for more stringent rules later.
The Senate version of the FDA bill included room for a law that would require a uniform drug tracing system, based on an amendment proposed by Senators Richard Burr, a Republican from North Carolina, and Michael Bennet, a Democrat from Colorado.
But after a new draft was proposed late on Friday, lawmakers could not get all sides to agree on how quickly the United States would move toward a “unit level” system that tracks individual drug packages.
“The draft recognized for the first time that we do need to eventually get to unit-level tracking,” said Allan Coukell, director of medical programs at the Pew Health Group, which has been involved developing the legislation.
“But the timeline was very long. ... It was just unclear that (individual tracking) would ever actually happen.”
In the meantime, companies may have to start complying with at least one state’s laws on the issue. California passed its own law for a track and trace system in 2004.
While healthcare companies were able to delay its implementation three times, the plan is now scheduled to begin in 2015.
Virginia Herold, executive officer of the California Board of Pharmacy, said she supports a national drug tracing system, rather than a patchwork of separate state rules. But the Congressional draft system would take at least 10 years to create a truly secure system, she said.
“We know there are problems in the supply chain,” she said. “We need something to sort it out before we have a major public health event.”
Reporting by Anna Yukhananov; editing by Carol Bishopric