Seventeen months ago, the goal of the Pharmaceutical Distribution Security Alliance (PDSA) was to get a nationwide track & trace bill introduced into Congress and then get it attached to some “must-pass” legislation which would pull it through to certain passage. They found sympathetic members of both houses of Congress and they worked together to produce a single bill. Last summer the “must-pass” legislation was the Prescription Drug User Fee Act (PDUFA) which was combined with other bills and was enacted as the FDA Security and Innovation Act (FDASIA). See “What If RxTEC Isn’t Adopted?”, “PDUFA Will Not Include RxTEC” and “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.)
Unfortunately the track & trace Continue reading Federal Pedigree: Caught In A Web Of Politics
Watching the progress of the nationwide pharmaceutical track & trace bills in the U.S. Congress has been very educational. Now that different track & trace bills are on the floors of the Senate and the House of Representatives (see “InBrief: A Track And Trace Bill Has Made It To The House Floor” and “InBrief: A Track & Trace bill Has Made It To The Senate Floor”) I have been trying to pick up on the politics that underlies the current situation in an attempt to figure out what is likely to happen next.
Both of the current bills have been described as “bipartisan”. I don’t think that’s exactly true, but before I explain why, Continue reading The Politics Of Federal Track & Trace Legislation
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 Continue reading PDUFA Will Not Include RxTEC
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