Upton said he would schedule a markup on the proposal for May with the goal of sending a bill to Obama “by the August recess.”
Criminals are getting more sophisticated at copying drug labels and profiting from putting counterfeit medications into the $300 billion U.S. prescription drug market, according to Dr. Janet Woodcock, the director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research.
She advocated for putting serial numbers on individual medications to prevent fake or altered drugs from making it into the hands of consumers.
“If we don't know the chain of custody of a product,” she said, “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.
Lawmakers in both parties seemed open to changing the draft bill, which would require a 10-year congressional review of a tracking system and semi-annual testimony from the FDA. It would preempt state laws currently in place to protect the safety of prescription drugs, including those in California and Florida, but critics said it offers no replacement.
Though the draft bill includes new safeguards, Rep. Gene Green (D-Texas) said the bill actually would prohibit the FDA from implementing an electronic tracking system.
Green called the legislation “a good bill,” but said, “it doesn't go far enough,” and that the technology will likely be available within 10 years.
“I don’t want to tie our hands,” he added.
Electronic records that track drugs through the complex distribution system from manufacturer to clinics and hospitals would be a “tremendous tool” to help thwart ineffective or dangerous counterfeit medications from reaching consumers, Woodcock said.
Rep. Frank Pallone (D-N.J.) pressed for the final bill to have language that allows the agency to track individual drugs, saying that might not otherwise happen.
“You know me, I've been here for awhile,” he said. “Inertia is often what characterizes this place, so if we want… [unit-level tracking], we should say we want [unit-level tracking].”
Pharmaceuticals are produced and sold in large lots, consisting from anywhere from 1 million to 100 million individual units. Lawmakers and witnesses at the hearing reached a general consensus on moving to a phase I of lot-level tracking that would lead to a phase II of being able to trace individual products.
The FDA investigates injuries and deaths that happen because of ineffective drugs made by counterfeiters, but are forced to put together a flurry of puzzle pieces through interviews and investigations to find out where the drugs came from.
"This is why we're doing this. Our current system is not structured to best mitigate this problem,” Matheson said. “The bad guys are getting smarter, more aggressive and there is just too much money on the table to have them not want to do bad things.”
The seven researchers and representatives from the industry attending the hearing — including those from Johnson & Johnson Health Care Systems, the Healthcare Compliance Packaging Council and National Community Pharmacists Association — said a 10-year phase-in approach to develop the unit-level tracking technology is likely possible.
Rep. Morgan Griffith (R-Va.) agreed with the need stronger safeguards, but expressed a concern about small-town pharmacies being unable to comply with expensive regulations.
Woodcock said legislation requiring a tracking system would likely spur innovation to create the technologies needed, so that community pharmacies could eventually comply without excessive burdens.
Crafting a goal would create predictability, especially for smaller entities, which “will be helpful for everyone,” she added.
Griffith emphasized that when moving forward with that plan, Congress does it “in such a way that community pharmacists don’t get left out of the equation,” he said.
Legislation passed last year creates some oversight for the beginning of the drug supply chain, but Rep. Joe Pitts (R-Pa.) said, “A comprehensive ‘track and trace’ package has yet to be finished.”
The Food and Drug Administration Safety and Innovation Act passed last year allows the FDA to collect user fees from industry in order to finance reviews of new drugs, medical devices and generic drugs. The law also renewed the Prescription Drug User Fee Act for the fifth time, which allows regulators to fund investigations and reviews of medications. ￼