“If we don’t know the chain of custody of a product,” and what hands the drug has moved through, there are “great delays” in rapidly identifying reports of substandard or counterfeit drugs, as well as adverse events, Janet Woodcock, M.D., director of the US FDA’s CDER (Center for Drug Evaluation and Research) told congressmen at a House Energy & Commerce Health Subcommittee hearing on Thursday.
But the details of what that track-and-trace system should entail – such as whether it should be electronic, how and when it will be implemented, and the technology that should be used -- are all still up for discussion as both the US Senate and House of Representatives introduced separate draft bills over the past week.
“My concern is that the House discussion draft doesn’t even set up the goal for an electronic, interoperable unit-level system, it merely requires that the FDA and GAO report back to Congress in 10 years on ways to enhance the security” of the US supply chain, Rep. Frank Pallone (D-NJ) said. He added that Congress needs to spell how such a system will work and allow for sufficient time and requirements to better safeguard the nation’s drug supply.
Despite the disagreements, House Energy and Commerce Committee Chairman Fred Upton (R-MI) predicted that track-and-trace legislation will be marked up in the committee in May and will be approved by August.
Unit-Level vs. Lot Level
Both the House and Senate bills seek to establish a lot-level system that eventually transitions to a unit-level system over ten years, but some congressmen contend that transition does not come soon enough.
Rep. Harry Waxman (D-CA) said “we need enough time to allow the technology to evolve” but a unit-level system seems to be right for the country and the current House draft would not establish that.
Woodcock also stressed the importance of a unit-level system, rather than a lot-level system, that could track products down to the individual patient level, and ultimately include pharmacies. But Rep. Morgan Griffith (R-VA) expressed concern that pharmacies, especially smaller rural ones, might not be able to afford to take part in such a system.
Woodcock said that ultimately “if we want to know what the patient got,” pharmacies will have to join any track-and-trace system. If Congress develops standards and a plan, “then vendors will come in and establish solutions over time,” that would slowly become more affordable for the smaller players, she added.
California, Other State T&T
The delay of the establishment of a unit-level system also drew the consternation of other stakeholders that are preparing for California’s unit level track-and-trace system, slated for implementation in 2015.
Rep. Bill Cassidy, MD (R-LA) stressed the difficulty of establishing timelines, especially as California delayed implementation of its own track-and-trace law.
Rep. Waxman added that he’s “deeply concerned” that “on day one” after this bill is passed, it would pre-empt all state laws and wipe out current licensing and pedigree requirements in California, Florida, New York and others that are currently developing such legislation.
National standards are desirable, “but we don’t want to tie the hands of states that need to focus more locally,” Alan Coukell, director at the Pew Health Group, said.
However, Rep. Jim Matheson (D-UT) said the concerns around the timing of pre-emption should not prevent the US from establishing one set of rules for the country and not 50 different sets for each state.