Doug Farry Quoted on ePedigree in San Diego Business Journal
According to the San Diego Business Journal, the California State Board of Pharmacy plans to meet tomorrow, March 25th, to discuss delaying the implementation of the state-imposed drug e-pedigree requirements, set to take effect January 1st, 2009. Meanwhile, the FDA is tasked with having federal guidelines in place by 2010. Doug Farry, a managing director at the McKenna Long & Aldridge office in San Diego, was quoted noting the difficulty of enforcing federal standards: “The FDA was really built to regulate the safety and efficacy of drugs.”
Whatever the state of California is doing will be significantly affected by similar ePedigree efforts being driven at a national level by the FDA. The FDA is not interested in California and 49 other states having their own, separate ePedigree requirements - so, anything that the FDA does in this arena will likely trump the various state efforts. The biggest challenge for FDA, as well as the state regulatory agencies, is how to enforce it. The FDA does not buy or sell drugs, it simply regulates their safety - so how will it enforce a requirement that everyone in the drug pedigree food chain use RFID or any other technology?
The California State Board of Pharmacy has the authority to extend the deadline for up to two years.
You can read our other posts about the California e-Pedigree developments in California and at the federal level here:
Bio, Pharma Companies Seek Extension to ePedigree Deadline in California
FDA Continues to Push for RFID
Court Blocks RFID-Friendly FDA Rules
