Legislative Tangle

Late last November, the U.S. Food and Drug Administration’s attempts to require the pharmaceutical industry to establish electronic pedigrees—documents that trace the movement of drugs throughout the supply chain—hit yet another roadblock. A district court in New York enjoined the government from enforcing a portion of the Prescription Drug Marketing Act (PDMA), the law that allows the FDA to implement pedigree requirements.

The lawsuit, filed by several secondary wholesalers, has to do with whether a drug’s pedigree must extend back to the manufacturer or only to the most recent “authorized distributor of record.” The plaintiffs claim that having to trace drugs back to the manufacturer would effectively put them out of business. The FDA has appealed the decision.

“We view the effort to implement widespread use of electronic pedigrees as somewhat separate from the PDMA,” says Ilisa Bernstein, the FDA’s director of pharmacy affairs. “What [the lawsuit] does affect is the information that’s on the pedigrees that are required to be passed today.”

At the same time, however, the FDA pushed back its December 2006 target date for when electronic pedigrees must be implemented. “Back in 2003 and 2004, wholesalers, pharmacies and manufacturers told us ‘RFID is promising; we’re going to have widespread use of track and trace by 2007,’” Bernstein says. Now, the FDA is leaving it up to private industry to say when e-pedigrees will be fully implemented.

Meanwhile, several states have taken matters into their own hands. Carmen Catizone, executive director of the National Association of Boards of Pharmacies, is watching three states in particular:

California has passed a law requiring electronic pedigrees, using RFID technology, beginning in 2008. Catizone says that the law has run into serious resistance, due to industry complaints that the technology is not ready and also is too expensive.

Florida has passed a law that requires paper or electronic pedigrees for all prescription drugs. However, Catizone says, it applies only to secondary wholesalers rather than the main supply chains.

Oklahoma has passed legislation involving drug pedigrees but is just starting a task force that will decide how to implement the law.

Copyright © 2007 IDG Communications, Inc.

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