FDA Speaks at Annual HDMA Track-and-Trace Conference

By Andrew J. Hull* & William T. Koustas –

With the January 1, 2015 implementation of the Drug Supply Chain Security Act (DSCSA) looming over the heads of both FDA and industry, the Healthcare Distribution Management Association (HDMA) held its annual track-and-trace conference November 10-12, 2014.  Foremost on everyone’s mind was the pending and highly anticipated draft guidance from FDA—due on November 27th—regarding implementation of the new law and the creation of a national database for monitoring drug transactions throughout the supply chain.  Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect.

Dr. Connie Jung, Acting Associate Director for Policy and Communications for the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, once again spoke at the conference and attempted to address some of their concerns.  Dr. Jung suggested that FDA expects supply chain members to begin complying with the DSCSA on January 1st, but was less confident about FDA’s ability to release the long-awaited draft guidance on time.  Dr. Jung stressed that FDA is diligently working to produce the draft guidance by the November 27th statutory deadline (Thanksgiving Day), but she was very reluctant to commit to the timing of its release.  Dr. Jung was less reluctant with regard to the development of the wholesaler and third-party logistics provider (3PL) databases.  She was much more confident that these databases would be running by the statutory deadlines, January 1st and November 27threspectively.

Dr. Jung also addressed numerous questions in a lively Q&A session.  Most significantly, she hinted that FDA would likely view an advanced shipment notification (ASN) system as an appropriate system to pass tracing information required under the DSCSA, and she stated that FDA would have to issue further guidance regarding proper reporting requirements for potentially fraudulent transactions.

Another highlight of the HDMA conference was HDMA’s own discussion and analysis of the federal preemption issues and ongoing state initiatives to comply with the DSCSA.  Specifically, HDMA expressed its opinion that the DSCSA preemption provision for wholesale distributor and 3PL licensing set both a floor and ceiling on state law licensing requirements, similar to the DSCSA’s preemption of state pedigree laws.  This analysis seems to run counter to FDA’s interpretation (see our previous post here) that indicates that states must only meet the minimum standards set forth by federal law.  HDMA also stated that several states (AZ, CA, CO, FL, ID, KS, MD, OK, OR, and VA) have already begun the process of updating existing licensing laws.  Most states, however, seem to be waiting for FDA to issue regulations before revising their own laws.

All in all, the members of the drug supply chain at the HDMA conference represented a level of anxious anticipation for more specific direction from FDA regarding the drug-tracing provisions of the DSCSA and a feeling that they will be more than thankful if the draft guidance actually comes as promised on Thanksgiving Day.  We here at HPM will continue to watch for the pending draft guidance and keep you posted with any new developments over the next couple of weeks.

* Not admitted in D.C.  Work supervised by the Firm while D.C. application pending.