Pharmaceutical and Medical Device Industries Face RFID / SCM Challenges and Opportunities in 2009
An increase in government activity affecting the use of RFID and other related SCM technologies in the pharmaceutical and medical device industries is expected in 2009, both in the United States and the EU. These actions will drive the future of these technologies and their impact on the precision, efficiency, and safety of pharmaceutical supply chains globally. It will be critical for companies affected by these industries to participate and help shape these government decisions - or risk having harmful decisions made in the next year.
The U.S. Department of Commerce and the European Commission are eager to promote RFID in Europe this spring within the context of the Transatlantic Economic Council. Following a very successful U.S./EU RFID symposium last fall, both sides have committed to jointly pursue frameworks for advancing transatlantic economic integration to build upon the success of an initial RFID pilot project to demonstrate best practices in other areas including health care and environmental sustainability.
Companies concerned with how upcoming RFID/SCM requirements will affect their global supply chains have an opportunity to influence the outcome.
U.S. and EU Collaboration on RFID Standards, Policies, and Implementation
The U.S. Department of Commerce and the European Commission are expected to continue collaboration on RFID within the context of the Transatlantic Economic Council. At the 2007 U.S./EU summit, there was a commitment to jointly pursue adoption of a framework for advancing transatlantic economic integration. The initial U.S./EU collaborative RFID pilot project to sort, track, and monitor medical and industrial radioisotopes in commerce was announced in October 2008. Both sides want to build on the success of that pilot project to demonstrate best practices in other practice areas. As a continuation of this initiative, the European Commission is planning a symposium and "matchmaking" RFID event this spring in Brussels - bringing suppliers, customers, and government entities together to develop mutually beneficial solutions.
Since policymakers in both the EU and U.S. will be carefully monitoring the initial pilot project to inform their decisions about laws and regulations governing RFID in pharmaceutical and medical device supply chains, this forum and matchmaker event is an outstanding opportunity for companies to participate and help shape outcomes with regard to their business strategies.
U.S. Federal E-Pedigree Standards Deadline
In the summer of 2007, the U.S. Congress passed the Prescription Drug User Fee Reauthorization Act, allowing the FDA to collect fees from those seeking drug approval in the U.S. to fund regulatory and oversight operations. Improved drug safety, particularly the need to reduce contaminated and counterfeit drugs from entering U.S. supply chains, continues to be a key focus of federal lawmakers. The legislation gave the FDA 30 months to develop technology standards for imposing electronic pedigree requirements on pharmaceutical products and eventually medical devices. That deadline expires in Spring of 2009. While it is likely to slip, since the new Obama Administration’s political appointments will not be confirmed by then, 2009 will be the year that FDA establishes Federal ePedigree standards. Given the history of support for the technology, that standard will likely include RFID in some way.
This has both positive and negative consequences – the standards established may or may not be consistent with your existing SCM systems, and the likely “phased-in” implementation of new drugs and devices to be covered by the requirement may or may not be consistent with your business strategy. With the recent election of Representative Henry Waxman (D-CA) as chair of the House Energy and Commerce Committee, Congress will likely see a more aggressive and regulatory-minded policy maker overseeing the FDA and it’s implementation of these standards. New liabilities, including requirements involving data privacy and security, may enter the debate in new ways.
