After a nationwide drug tracking system failed to be included into the FDA user fee legislation passed in July 2012, legislation was re-introduced on Wednesday, Oct. 24, 2012, to create a nationwide drug tracking system at the lot level. The idea of a nationwide track-and-trace system has both bipartisan support and industry support, and the industry hopes the legislation will be passed by the end of the year. The following are three key points regarding the proposed legislation. 

  1. Preemption of State Law. The nationwide system will preempt any state tracking systems, including, as currently drafted, tracking systems that are more stringent than the nationwide system. Industry lobbied for this broad preemption clause in response to California’s stringent track-and-trace system, which the industry argues is technologically impossible to meet.
  2. Tracking at the Lot Level, instead of the Unit Level. The legislation currently requires tracking at the lot level, instead of the unit level, which will be easier for manufacturers to comply with. The industry argues that unit-level tracking is currently technologically unfeasible and prohibitively expensive. Conversely, consumer advocates and FDA officials are wary that lot-level tracking will not effectively prevent counterfeit and adulterated products from entering into the pharmaceutical supply chain.
  3. Pilot Programs, Public Meetings and Future Regulations. The previous draft for a nationwide drug tracking system in the FDA user fee legislation called for a unit-level tracking system at an undetermined date. The lack of a definitive timeline was a deal-breaker for consumer advocates’ support of the drug tracking legislation. The current version of the draft legislation calls for FDA to conduct pilot programs with industry to explore and evaluate methods to rapidly and effectively detect and identify suspect products throughout the supply chain. This includes efforts to improve the technical capabilities of each sector and subsector to comply with an interoperable, electronic, unit-level package tracking system. Additionally, the Secretary would hold public meetings to discuss how to create an effective tracking system. Lastly, the current draft legislation explicitly requires further regulations within a five- to ten-year timeline, requiring maintenance and provision of transaction data at the unit level.