PhRMA Statement on California's E-Pedigree Law

Washington, D.C. (March 25, 2008) —Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today on the extension of the deadline for implementing California's e-pedigree requirements:

"The California Board of Pharmacy's vote today to delay implementation of the state's e-pedigree law until 2011 is an acknowledgement of the complex regulatory and technological challenges that still must be overcome. And it is possible that even by 2011, some of thekey challengeswillremain and still need to be resolved. Most importantly, the vote demonstrates board recognition of the importance of protecting patients throughout the state during the transition to new e-pedigree requirements.

"Clearly, more time was needed for effective implementation of the e-pedigree law. And now there's an extension of two years, which allows a longer period for a number of things to happen. For example, the makers of blood products -- such as those that treat hemophilia -- have two additional years to test the effects of radio-frequency identification (RFID) on the treatments. And they have more time to encourage the Food and Drug Administration to provide guidance on how companies should test to determine whether heat generated by the RFID system affects either the safety or effectiveness of blood products.

What's more, researchers will have more time to address the technology compatibility problem that confronts those trying to implement the law. The fact is, the technology exists to track medicines, but we do not have one standard electronic serialization system everyone can use to monitor medications throughout the pharmaceutical supply chain. In addition, there's now more time for state and local government agencies in California to resolve the budget crises they face. Organizations like the California Department of Corrections, state mental hospitals, California State University campus clinics and University of California hospitals must purchase many different expensive technologies to be in compliance with the law. And accomplishing that goal by January 1 would have been a daunting task.

"Another problem is some pharmaceutical research companies with a wide range of medicines are concerned that there's a limited number of technical experts to reconfigure product packaging and labeling lines. Changing the labels and obtaining FDA approval of the new lines could not have been done in time to meet the old deadline.

"America's pharmaceutical research companies intend to use the additional time wisely. The companies and the rest of the pharmaceutical supply chain are committed to moving forward with implementation of all e-pedigree requirements. But given the importance of patient safety, we will continue to focus first on medicines that have a high risk of being counterfeited. That concentration will enable pharmaceutical research companies to tackle the many problems they face in serializing the packaging of medicines and obtaining FDA approval of the changes. The companies will also make sure the information is conveyed to other supply chain partners.

"Today's vote was a vote for effective and safe treatment of patients since retaining a rigid January 1, 2009 starting date would have undoubtedly disrupted the entire pharmaceutical distribution chain. Millions of Californians could have been denied critically important medicines and quality of care throughout the state could have been dangerously compromised."

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.

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