FDA pedigree rule targets fake drugs

Electronic tracking is eyed as an efficient way to plug gaps in the supply line and block the entry of counterfeit pharmaceuticals.

By Susan J. Landers, AMNews staff. July 24/31, 2006.

Washington -- Drugs soon will be required to come with a paper or electronic trail to help distinguish the real thing from the counterfeits.

The Food and Drug Administration decided last month to adopt recommendations made in an agency task force report and end a long-standing hold on regulations called for in the Prescription Drug Marketing Act of 1987.

That law required drug distributors to provide documentation of the chain of custody of drug products -- a pedigree -- throughout the distribution system. Although final regulations implementing the law were published in 1999, the FDA delayed the effective date because of the fear that it would be too costly for small distributors to comply.

But as the cost of pharmaceuticals rose, so did counterfeiters' interest and attraction. "We could no longer justify continuing the stay," said Randall Lutter, PhD, FDA's associate commissioner for policy and planning, at a June 9 briefing. The regulation is set to take effect Dec. 2.

The need to institute safeguards had become apparent as increasing numbers of sophisticated fake medications infiltrated the supply line and hit the U.S. market. "Counterfeits are problematic because good ones are indistinguishable, even to the trained eye, from authentic products," said Dr. Lutter.

While only six instances were detected in 2000, there were 32 in 2005. And in 2004, 58 cases were detected.

Although the United States has a very safe prescription drug supply, the need for vigilance remains, said Scott Gottlieb, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs, during a recent speech. The World Health Organization estimates that the counterfeit drug trade throughout the world is a $32 billion-a-year enterprise.