By Megan R. Wilson - 05/08/13 02:36 PM EDT
The draft bill, discussed with the Food and Drug Administration (FDA) and industry officials last month, would close loopholes in the supply chain and aim to prevent counterfeit drugs from reaching consumers.
“Securing the supply chain through this bill will help ensure that counterfeit or stolen drugs do not enter the supply chain and harm patients,” said Rep. Joe Pitts (R-Pa.) at the beginning of the markup on Tuesday afternoon. “It will also ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages.”
Reps. Lois Capps (D-Calif.), among others, voiced a concern that the regulatory framework would take too long to implement, as the bill would not require regulations from the FDA until 2027.
She and others said the law would preempt strict state-level laws already in place without providing an alternative until those rules are put in place.
Reps. Fred Upton (R-Mich.) and Frank Pallone Jr. (D-N.J.) agreed to discuss the potential shortcomings, but warned about the burden the new requirements could place on small pharmacies.
Following the hearing with FDA and industry representatives on April 25, Reps. Bob Latta (R-Ohio) and Jim Matheson (D-Utah) – the bill’s authors – strengthened provisions in the draft that would require drug manufacturers, wholesale distributers and pharmacies to be able to provide a prescription drug’s entire transaction history by Jan. 1, 2015.
It also adds the 2027 deadline for the FDA to propose rules to implement the unit-level traceability the agency has pressed Congress to provide.
Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, met with lawmakers at the April meeting and urged for the more rigorous standards.
Criminals are getting more sophisticated at copying drug labels and profiting from putting counterfeit medications into the $300 billion U.S. prescription drug market, she said at the meeting.
“If we don't know the chain of custody of a product,” she continued, “if we have to reconstruct that later, through questioning people, that could cause great delays” in recalling the product or finding out where the problems occurred.
During the consideration of the second draft, Upton – the chairman of the Energy and Commerce Committee – still wanted to push it forward.
“This markup is an important step in finishing the bipartisan work on securing the prescription drug supply chain that we began well over a year ago,” he said.