Unit-level track and trace considered by Congress
Both the House and Senate bills would require lot-level tracing
The issue of counterfeit pharmaceuticals has resurfaced in recent weeks on Capitol Hill. Bills introduced in both the Senate and House of Representatives would use “track and trace” technologies to follow medicines through the supply chain at the lot and unit levels.
The House Energy & Commerce Committee on May 15 approved the Safeguarding America’s Pharmaceuticals Act (H.R. 1919) following its Subcommittee on Health hearing on its discussion draft on April 25, an updated version of the draft on May 3, and introduction of the bill on May 9.
The House bill would establish lot-level tracing requirements and would require proposed regulations in 2027 for unit-level track and trace.
The Senate Health, Education, Labor, & Pensions (HELP) Committee on May 15 introduced the Drug Supply Chain Security Act (S. 957) following the release of a discussion draft on April 19. As Today went to press, the HELP Committee on May 22 held an executive session where the track-and-trace bill was combined with a compounding bill into one bill (see page 64 for more information on compounding).
The Senate bill would set forth lot-level product tracing requirements for downstream supply chain members and would establish a 10-year timeline for serializing product and transferring only serialized product.
Bar code technology
In the March/April 2012 issue of the Journal of the American Pharmacists 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.
“It’s contemplated that the product identifier would be on a 2D bar code,” said Elizabeth A. Gallenagh, JD, Vice President of Government Affairs and General Counsel, Healthcare Distribution Management Association. She explained that serialization means an identifying number that’s a unique ID for each individual product—for example, two bottles of Lipitor would have two different numbers—where that number would be on the 2D bar code.
National approach needed
Both the Senate and House bills, upon enactment, would preempt state-level tracing requirements.
“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 Today after attending the April 25 House hearing, Securing Our Nation’s Prescription Drug Supply Chain. “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.”
FDA supports unit-level tracing
At the hearing, FDA demonstrated its support for unit-level track and trace, according to Weaver.
In one exchange, Rep. Joe Pitts (R-PA), Chair of the health subcommittee, 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 that predictability and a timeframe were important to address community pharmacists’ logistical and time concerns.
Another witness 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, according to an April 25 NCPA news release, he expressed concerns about potentially burdensome legislative requirements on small business community pharmacies.
APhA monitors track and trace action
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 bills.