Unit-level track and trace considered by Congress

Senate, House looking at problems in supply chain for drug products

The issue of counterfeit pharmaceuticals has resurfaced in recent weeks on Capitol Hill. Draft proposals introduced into the Senate and House of Representatives would require use of “track and trace” technologies to follow medicines through the supply chain at the lot and unit levels.

The Senate Health, Education, Labor, & Pensions Committee released a discussion draft on April 19. The House Energy & Commerce Subcommittee on Health followed with a hearing on its discussion draft on April 25 and an updated version of the draft on May 3 that will be marked up by the subcommittee on May 8 and by the full committee shortly thereafter, according to APhA Senior Lobbyist Michael Spira.

In the March/April 2012 issue of the Journal of the American Pharmacist Association, an article on the role of the pharmacist in preventing distribution of counterfeit medications explained that “track” means the identification of the product location in real time as it moves through the distribution chain, and “trace” means providing a record of where a product has been.

The Senate draft proposal to improve drug distribution security would set forth lot-level product tracing requirements for downstream supply chain members, and would establish a timeline for serializing product and transferring only serialized product. The Senate draft would not dictate the technology and the standards, which would evolve from public meetings and guidances by FDA that reflected those public meetings.

The initial House draft would establish lot-level tracing requirements but would only have established a process among FDA and stakeholders to “better understand how and when to move to unit-level traceability,” according to the majority memo for the House hearing, Securing Our Nation’s Prescription Drug Supply Chain. But the updated version would establish a 14-year timeline for unit-level track and trace, Spira told pharmacist.com.

The House draft proposal legislation is not prescriptive on what unit-level technology will be required. FDA’s regulations would be based on what is feasible and reasonable at the time based on pilot projects, studies, and independent third-party assessment and the formal rulemaking process.

Both the Senate and House drafts, upon enactment, would preempt state-level tracing requirements.

“In order to ensure that counterfeit or stolen drugs do not enter the supply chain and harm patients, states have passed laws that require, or will require, those involved in the downstream supply chain to keep pedigrees or transaction histories of drugs,” according to the written opening statement of Rep. Joe Pitts (R-PA), Chair of the health subcommittee. “Some believe that these differing state requirements should be replaced with a reasonable, practical and feasible federal policy.”

“Legislators on both sides of the aisle agree that eventually unit-level track and trace would benefit the patients of the United States,” Krystalyn Weaver, PharmD, APhA Foundation Executive Resident, told pharmacist.com after attending the hearing. “There is much disagreement, however, on the implementation timeline.”

Weaver pointed to legislation in California requiring a unit-level, interoperable track-and-trace system to be implemented by 2015 as the “driver for urgent change at the national level on this issue.”

At the hearing, FDA demonstrated its support for unit-level track and trace, according to Weaver. In one exchange, Pitts said that lot-level tracing was better than nothing, but first witness and FDA Center for Drug Evaluation and Research Director Janet Woodcock, MD, replied that unit-level tracing is needed to reach the goal of protecting patients. Then Rep. Frank Pallone Jr. (D-NJ), Ranking Member on the health subcommittee, said that everyone shared the same goal and needed to improve the legislation to achieve it.

In subsequent exchanges, Woodcock said that Congress should provide clarity on what the shared goal is, and that whatever is enacted shouldn’t lower state-level safety requirements about the drug supply—which is what would happen if the state laws were taken away without replacing them with an equally stringent federal requirement.

Woodcock also said that the pharmacy must be included in the track-and-trace system to know which patients got a drug in question, and indicated an understanding of the concerns of the community pharmacist. These concerns included logistical and time concerns—a reason for Woodcock as to why predictability and a timeframe were very important.

Another witness at the hearing was Tim Davis, PharmD, owner of Beaver Health Mart Pharmacy in Beaver, PA, on behalf of the National Community Pharmacists Association (NCPA). In his remarks, he expressed concerns about potentially burdensome legislative requirements on small business community pharmacies, according to an April 25 NCPA news release.

Davis also said that at this time, technologies required to implement a system to track prescription drugs at the individual unit level “are not fully developed and have not been designed or scaled to be feasible or affordable for use in individual community pharmacies.” He called for a common-sense federal approach that balances enhanced patient safety with minimized burdens on supply chain stakeholders, according to the news release.

During last summer’s passage of the Prescription Drug User Fee Act reauthorization, conversations around track and trace were ongoing; track and trace did not make it into the final bill, but the hope was to have an agreement to include in other health care legislation.

APhA, with other national and state pharmacy associations, continues to monitor the progress of the draft proposals.