Track and trace has apparently been trashed, at least for now.
Unable to agree on details between what the FDA was seeking and what the industry was willing to sign off on, the plan to finally create a nationwide system that could identify and follow an individual drug through a serpentine supply chain got left on the negotiating floor, Reuters reports, citing anonymous congressional staffers. The plan was to be a part of the FDA user fee reauthorization bill that Congress has been reconciling, one of the few pieces of legislation with bipartisan support in this tense pre-election session.
A staffer said some lawmakers may try to introduce the measure as a stand-alone bill later this year. But the legislation may have a hard time making it through a divided Congress. Some legislators have indicated they will try to get something approved in a standalone bill later this year, Reuters reports, but chances of passage would be slim.
The need for tracking has been kicked around for at least a decade, but it took on renewed urgency this year when counterfeit version of such drugs as Roche's ($RHHBY) cancer treatment Avastin and Teva Pharmaceutical ($TEVA) ADHD treatment Adderall started popping up around the country. California has passed its own law that should start in 2015, which could lead other states to follow, a situation both the FDA and the industry has hoped to avoid.
- read the Reuters story