Judge Aims to Halt FDA’s E-Pedigree

The Prescription Drug Marketing Act set to go into effect in January 2007 that would require a prescription drug “pedigree” or electronic paper trail on distributed pharmaceuticals, has hit another snag.

A federal lawsuit filed by eight pharmaceutical wholesalers against the FDA’s Department of Health and Human Services, has been answered with a preliminary injunction issued Dec. 8.

For more on IT and the pharmaceutical industry, see E-Pharmacists Improve Patient Safety, Staff Efficiency

The result: The FDA’s pedigree mandate has been stayed, potentially for years, as the courts work through the legal claims of the wholesalers.

The ruling, while it may not cause huge ripples in the pharmaceutical industry itself—many distributors are already complying with state pedigree mandates—could have a chilling impact on the proliferation of RFID in the pharmaceutical industry.

While it has not mandated a specific technology that companies have to use to determine a drug’s pedigree, the FDA strongly supports the use of RFID.

Read the full story on eWeek.com: Judge Aims to Halt FDA’s E-Pedigree