Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee. That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill. See “’Track And Trace’ On Ice For Now” in Politico PULSE.
According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”
Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates. The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal. The success of such an approach likely depends on how close the negotiations were to an agreement when time ran out.
WHAT IF RxTEC ISN’T ADOPTED?
In a widely read essay back in March I speculated what would happen if RxTEC wasn’t adopted by Congress this year. I highly recommend that you (re)read my essay called “What If RxTEC Isn’t Adopted?”. It was my longest essay yet so you might want to skip down to the last section where I speculate on what might happen next if the PDSA failed to get RxTEC attached to PDUFA. It may have more pertinence now that that is exactly what appears to have happened. When you’re done reading that, read my much shorter essays, “The Preemption Provisions Built Into The California Pedigree Law”, “California Enforcement Subcommittee Moves To Require FDA SNI” and “InBrief: FDA To Publish Track & Trace Standard By Year End” and decide for yourself how solid my theories are about what could happen next.
It goes something like this. The FDA will publish their Track & Trace standard later on this year. California’s existing law could be interpreted as requiring the Board of Pharmacy to adopt the FDA’s standard for Track & Trace, just as it recently did for the FDA’s Standardized Numerical Identifier (SNI). In that case we might be looking at a completely different architecture for California ePedigree by the end of the year, one that could be viewed more favorably by some, less so by others.
What do you think will happen? Leave your thoughts in a comment below.