FDA pedigree rule targets fake drugs

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.

Since drugs are often passed along through several distributors on their way from manufacturer to pharmacy and patients, the FDA's pedigree requirement is intended to shed light on just where the drug has been. Smaller distributors are particular targets of the new rule.

"Our extensive experience with counterfeit and diversion cases reveals that the secondary wholesale market is where much of the illegal activity occurs," Dr. Lutter said.

Switching from paper

Initially, the FDA had delayed implementing the pedigree requirement, anticipating that electronic track-and-trace technology, or e-pedigrees, would become widely adopted by 2007, thus eliminating the need for more ponderous paper trails. Since that advance seemed less and less likely, the agency decided to release its hold on the regulations now. Those distributors who do not have technological tracking systems in place by December will have to rely on a paper trail.

Meanwhile, e-pedigrees are gaining popularity, and distributors and manufacturers are switching to them in greater numbers.

Pfizer began shipping Viagra with radio frequency identification tags at the beginning of the year, and FFF Enterprises, a California-based distributor, began sending its products with e-pedigrees in June 2004.

States also have begun to require pedigrees. Florida was the first -- its law took effect July 1. Sixteen other states have also passed legislation.

But proponents of strong pedigree requirements were disappointed with the law signed June 29 by Florida Gov. Jeb Bush. It exempts distributors who ship directly from manufacturer to pharmacy from supplying a pedigree. The companies need only supply a document explaining that the drug came directly to them from the factory.

"We find that to be an unconscionable weakness in the legislation," said K.B. Gressitt, the vice president of marketing and communications for FFF Enterprises. Although the company prides itself on shipping only from manufacturers to health care providers and would be exempt under the Florida law, it strongly favors a pedigree requirement, Gressitt said.

Similarly, the federal law exempts some distributors -- those designated "authorized distributors" with an "ongoing relationship" with manufacturers -- from providing a pedigree. That exemption constitutes a loophole like that found in the Florida law, Gressitt said.

Of course, there is no perfect security, notes Shabbir Dahod, president and CEO of SupplyScape, a Massachusetts firm that develops e-pedigree products for distributors. But e-pedigrees make it more difficult and less profitable for criminals to stay in the game, he said.

"Criminals are businessmen as well, and once it becomes something they can't do in volume, the cost is high and the probability of getting caught is high then they will not do it," Dahod said.

The FDA also agreed to go along with the task force recommendation to target the agency's enforcement efforts, at first, on popular and high-cost specialty drugs as well as on those drugs that are in short supply or that have been subject to counterfeit efforts previously. Examples include Lipitor, Nexium, Plavix, Procrit, Viagra, Oxycontin and metered-dose inhalers.