March 3, 2006

A bipartisan coalition of lawmakers has introduced legislation requiring electronic tracking of prescription drugs to prevent a growing problem with counterfeit medications, but some critics say the bill does not go far enough in immediately addressing the problem.

The bill, H.R. 4829, requires the HHS secretary to develop a list of the 30 drugs most frequently counterfeited within 180 days of the bill's passage, the lawmakers said March 1. HHS also would be required to use tracking technology, known as radio-frequency identification (RFID), for the listed drugs no later than Dec. 31, 2007. RFID would be required for all prescription drugs by Dec. 31, 2010, the bill says.

Counterfeit drugs are considered a grave and growing threat because of uncertainty about the safety and efficacy of these medications, said Rep. Dan Burton (R-Ind.), the bill's sponsor. The legislation is necessary "before the growing scourge of fraudulent, imitation, and counterfeit prescription drugs grows even worse," he said. Cosponsors include Reps. Mark Souder (R-Ind.), Rahm Emanuel (D-Ill.), Stephanie Herseth (D-S.D.) and Bernard Sanders (I-Vt.).

RFID would be used to implement inventory control for these drugs, verify shipment or receipt of these products and electronically authenticate their pedigree. A drug's pedigree includes the history of each sale, and the names and addresses of all parties to the transaction. The bill would go beyond RFID to require tamper-indicating security measures in prescription drug packaging.

But Rep. Steve Israel (D-N.Y.), who proposed his own anti-counterfeiting bill last year, argues Burton's proposal does not go far enough. Unlike Israel's bill, H.R. 4829 does not require paper pedigrees until RFID technology is ready, said Israel's spokesman Ryan Rudominer. Israel's bill represents "a much more comprehensive approach," Rudominer added.

There needs to be an interim fix because industry is still working the bugs out of RFID, Rudominer said. Industry also has been slow to implement RFID, with only 10 prescription drugs expected to use the technology this year, a recent study shows. Industry has opposed paper pedigrees because of their additional cost and time burdens, said Rudominer. While the Prescription Drug Marketing Act of 1988 requires paper pedigrees, the law has had a temporary stay applied to it by the FDA and as a result has not been enforced. PhRMA, however, has urged the FDA to move forward with a paper-based system, saying the industry can't wait for electronic pedigrees.

Burton is unwilling to add the paper manifest requirement, said his spokesman Stephen Schatz. While all plans to address counterfeiting have their own merits, "we believe our bill is superior" because it complements the efforts of the FDA and companies such as Pfizer, he added. The bill "gives the marketplace and relevant government agencies leeway to develop their plans" as well as ensuring "the safety of the American drug chain," he said. Industry and the agency have favored an electronic tracking system.