House PDUFA bill leaves out traceability08-Jun-2012
The US House of
Representatives passed a bill reauthorizing the Prescription Drug
User Fee Act (PDUFA) legislation last week without including a
provision for a national medicine traceability system, in contrast
to the earlier Senate version.
The Senate version (S. 3187) would add a new subchapter in the Federal Food, Drug and Cosmetic Act (FFDCA) that would incorporate the RxTEC supply chain security model proposed by the Pharmaceutical Distribution Security Alliance (PDSA) lobbying group, but no such provision is included in the House document (HR. 5651).
A side-by-side comparison of the two versions can be viewed here. The House and Senate versions must now be reconciled into a single bill for signature by President Obama, and the current expectation is that this will occur within the next few weeks.
Meanwhile, lobbying activity continues apace for the inclusion of a national traceability system that could supersede the electronic pedigree system due to come into effect in California between 2015 and 2017.
A legislative briefing took place at the US Capital Building earlier this week (June 6) to examine RxTEC, as well as alternative traceability models, and try to identify a way forward that would bolster the security of the US medicines supply chain without placing too much cost and disruption on stakeholders.
The RxTEC model included in S.3187 provides item-level serialization of medicine packs using 2D datamatrix codes - in accordance with the FDA's 2010 guidance on serialised numerical identifiers (SNIs) - and this would allow each item to be associated with a lot numbers and the quantity of units within each lot.
Traceability would only be applied to the lot level, and rather than providing full chain-of-custody as with California ePedigree model would identify only the previous and next owner/handler of the shipment. This is sufficient to secure the supply chain, according to the PDSA, although the California Board of Pharmacy (CBP) recently attacked the proposals in an open letter to Representative Henry Waxman.
Other measures included in the House and Senate bills that would update or introduce laws related to supply chain security include:
• Notification requirements for harmful, stolen or counterfeit drugs;
• Enhanced criminal penalties for counterfeiting drugs;
• Accelerate the adoption of a unique device identifier (UDI) for medical devices;
• Guidance on a unique facility identifier (UFI) system;
• Provisions for criminal penalties for intentional adulteration of drugs;
• Extraterritorial expansion of the jurisdiction of the FFDCA; and
• Destruction of adulterated, misbranded, or counterfeit drugs offered for import
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