March 2007 - Pharmaceutical Technology

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March 2007

Pharmaceutical Technology

FDA asked IOM to assess the US drug-safety system in 2005, and IOM released its report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, in Sept. 2006. The report included recommendations about how FDA could improve its drug-safety efforts.

The recommendations FDA intends to act on include: improving communication and information flow among all stakeholders, strengthening the science that supports FDA's medical-product safety system, and improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the US drug-safety system.

FDA also signed a memorandum of understanding with the US Department of Veterans Affairs (VA, to share information related to the review and use of FDA-regulated drugs, biologics, and medical devices. FDA and VA intend to explore ways to enhance risk communication and the collection of postmarket medical-product safety data and promote the efficient use of tools and expertise for medical-product risk identification.

FDA plans to develop scientific approaches to detect, understand, predict, and prevent adverse events. It hopes to develop and incorporate quantitative tools to assess benefit and risk, and it plans to conduct a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis. FDA also plans to engage external management consultants to help the Center for Drug Evaluation and Research (CDER, develop a comprehensive strategy for improving CDER's organizational culture.

If adopted by Congress, many of the recently proposed recommendations for the reauthorization of the Prescription Drug User Fee Act will respond to some of the IOM recommendations, thus providing increased resources for drug safety and added flexibility to FDA in the use of fee funding to address the entire drug life cycle.

-Brianne Harrison


EPCglobal Ratifies New Electronic Pedigree Standard

Brussels, Belgium (Jan. 11)—EPCglobal (, the not-for-profit organization dedicated to driving global adoption of the Electronic Product Code (EPC), has ratified the electronic pedigree document specification.

The new electronic pedigree standard is designed to help companies that are serializing products using EPC technology to comply with pedigree regulations. Its initial focus was the Florida Drug Pedigree Act, but it can be used as a platform to support a wide variety of pedigree process applications.

According to EPCglobal's president, Chris Adcock, the standard will ensure that "trading partners have an interoperable way to exchange document-based pedigrees for pharmaceuticals and other products." He adds that "supply-chain participants can begin to comply with document-based pedigree regulations without fear of serious interoperability issues."

The standard features an ePedigree document schema as well as an ePedigree envelope schema, which companies can use to hold multiple ePedigrees together in a single document for electronic transmission. It is meant to serve as a tool in the fight to protect brands against counterfeiting.

EPCglobal has also begun work to develop a full track-and-trace system based on the EPC Information Services (EPCIS) standard, which is expected in the first quarter of 2007. This new system would allow pedigree information to be shared both upstream and downstream, rather than passing the information from trading partner to trading partner in only one direction.

-Brianne Harrison


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