Will the approaching California E-pedigree law give Congress enough urgency to establish a national pharmaceutical track & trace system?
The US Congress is again discussing development of a nationwide tracking system for pharmaceutical products that would replace state programs. The House Energy & Commerce's Health Subcommittee held a hearing April 18, 2013 on a track & trace discussion draft and heard testimony from the FDA, manufacturers, distributors, and pharmacists.
The draft legislation would establish lot-level tracing requirements for manufacturers, wholesaler distributors, pharmacies, and repackagers based on changes in ownership. The proposal would also require manufacturers to serialize prescription drugs at the at the unit level. Pilot projects and biannual public meetings would be used to build consensus regarding how and when to move to unit-level traceability.
Draft Senate bill creates unit-level system
One week before the House, the Senate released a national track & trace discussion draft that would initially create a lot-level tracing system and then transition to unit-level tracing. The Senate draft would require interoperable, electronic unit-level product tracing after 10 years.
While the House and Senate proposals are similar, their end result is different which will delay passage. The House version requires a study after 10 years on how to establish a unit-level system, while the Senate version would shift from lot-level to unit-level product tracing. The draft bills do agree that all state product tracing requirements would be pre-empted.
Congress has tried before to implement a nationwide track & trace system for drugs. Section 913 of the FDA Amendments Act of 2007, which included reauthorization of the prescription drug user fee act (PDUFA), set the framework for the identification, validation, authentication, and tracking & tracing of prescription drugs. The target date for implementation was March 27, 2010 but this section was removed. Congress also removed track & trace legislation from PDUFA reauthorization legislation in 2012.
One thing that will spur Congress to action is an incursion on their authority and this latest attempt for a federal tracking & tracing system comes as California and other states continue to move forward with their own tracing systems. California is leading the charge and the state's E-pedigree law is scheduled to begin in 2015. Pharmaceutical manufacturers would like to see Congress pass tracing legislation before they will need to begin establishing procedures to comply with the California law, which could take up to 18 months.
The California E-pedigree would record each change of ownership from the manufacturer to the pharmacist in an interoperable, electronic system. During the hearing, California Democratic Representative Henry Waxman was in the position of advocating for a national law but not at the expense of pre-empting strong state laws if the objective isn't met. Waxman and other Democrats on the panel expressed that the goal should be a secure, interoperable, unit-level, electronic system.
At least one manufacturer has already begun developing an electronic drug tracking system in preparation for the California law. "We are preparing our packaging sites, distribution centers, business and information technology systems to serialize and track & trace our products so that we can comply with the California E-pedigree law," Johnson & Johnson Health Care Systems VP Michael Rose told the health subcommittee.
More to come
During the hearing, Energy & Commerce Committee Chair Fred Upton said he plans to bring track & trace bill up in May for committee review and send to the president by August. Differences between the House and Senate versions would also need to be resolved before the legislation gets to the President's desk. Stay tuned for further updates on the House and Senate track & trace legislation.
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