FDA rule on tracking prescription drugs is held up -- again

A federal judge temporarily delayed the track-and-trace regulation because of concerns it is unfair to some drug wholesalers.

By Doug Trapp, AMNews staff. Jan. 1/8, 2007.

Washington -- A repeatedly delayed federal rule requiring the tracking of prescription drug sales has been put on hold again, this time by a federal judge concerned that the regulation is an unfair burden to smaller drug wholesalers.

The Food and Drug Administration set Dec. 1, 2006, as the deadline for some drug wholesalers to begin providing transaction histories, known as pedigrees, tracing all of their drugs back to the original manufacturer. The rule stems from the Prescription Drug Marketing Act, signed into law in 1988.

Judge Joanna Seybert of the Eastern District of New York issued a temporary injunction against the rule Dec. 4, 2006, in response to a complaint filed by 10 drug wholesalers, including the lead plaintiff, RxUSA, located in Port Washington, N.Y.

An attorney for RxUSA argued that the pedigree rule would put the 4,000 unauthorized drug wholesalers in the United States out of business. The regulation requires unauthorized distributors, such as RxUSA, to provide pedigrees, while authorized wholesalers -- those with formal agreements with drugmakers -- are not required to do the same.

Unauthorized wholesalers represent less than 5% of sales in the American market, according to RxUSA President and CEO Robert Drucker.

Most unauthorized wholesalers' drugs at some point pass through the hands of authorized distributors, the ruling states, thus potentially making it impossible for unauthorized wholesalers to meet the pedigree rule. At least 95% of RxUSA's drugs make contact with an authorized distributor, Drucker said.