FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference

November 18, 2012

By Jess Ritsick & Bill Koustas

The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to explore how stakeholders will play a role—and what those roles may be—going forward.  Perhaps most interesting at the conference was the seemingly unanimous support from industry for the implementation of a national pedigree program in some form.  What follows below are some of the highlights of the conference speakers.

HDMA’s General Counsel and Vice President for Government Affairs, Elizabeth Gallenagh, discussed recent developments in track and trace, pedigree, and serialization at the federal level.  In addition to discussing the recent draft track and trace legislation, which we recently blogged about here, she also discussed the work being done by a “bi-partisan, bi-cameral” congressional working group, which brings together legislators, regulators, and industry and is looking to create a national pedigree system within the next year.  Congress tried to include a national pedigree in the most recent round of PDUFA legislation, but that was obviously not successful.  Ms. Gallenagh also noted that HDMA believed that a national pedigree system should have the effect of preempting state track and trace and pedigree systems. 

Turning to the state level, Virginia Herold, the Executive Officer of the California Board of Pharmacy, spoke about California’s state pedigree requirements, which are slated to begin taking effect in 2015—a date which Ms. Herold emphasized would not be pushed back by the Board of Pharmacy.  Ms. Herold expressed her hope that there would eventually be a national pedigree, but punctuated that hope with the fact that California would only be satisfied with a national pedigree system that proves to be “sufficient.”  Interestingly, with all the work done to draft California’s pedigree requirements, Ms. Herold stated there are no requirements for “passing” the pedigree; rather, the relevant information just needs to exist in an interoperable electronic system.  How this will apply practically, e.g., potential for fraudulent pedigrees, remains to be seen.  Ms. Herold also noted that failure to comply with the pedigree requirements may result in a $5,000 fine per transaction.  The California Board of Pharmacy will hold a public hearing on December 4, and a board meeting on December 13, 2012 to address the implementation of the state’s pedigree requirements. 

Lieutenant Commander TJ Christl, FDA’s Acting Director of the Office of Drug Security, Integrity, and Recalls also spoke briefly, and emphasized FDA’s support for a national pedigree and a robust track and trace system.  He emphasized that FDA hopes to work with industry towards a system that suits both the industry and the Agency.  FDA also remains committed to ferreting out counterfeit drugs in the national drug supply.  In that vein, Lieutenant Commander Christl stated that FDA recently sent letters to practitioners and the relevant state boards and agencies regarding the purchase of suspected counterfeit drugs from online retailers.  While the letters were purely informational and not considered enforcement actions, Lieutenant Commander Christl stated that the follow-up on the letters has yielded “successful outcomes.”