FDA intensifies attack on fake drugs

A multifaceted plan to stop counterfeits is beginning to take shape.

By Susan J. Landers, AMNews staff. Oct. 27, 2003.

Washington -- Digital watermarks, fluorescent tracers, scent markers, bar codes. They sound like spies' tools of the trade. But these are some of the possibilities the Food and Drug Administration is exploring to thwart a recent increase in counterfeit medications infiltrated into the nation's prescription drug distribution system.

An interim report from the FDA's Anti-Counterfeiting Task Force released in early October indicates that not much is off limits in the quest to quell this mounting public health threat.

"The FDA's task force is developing innovative approaches as never before on the significant and growing problem of counterfeit drugs," said FDA Commissioner Mark B. McClellan, MD, PhD.

The report covers protective technology, devices that track pills from manufacturer to pharmacy and new regulatory requirements to limit the opportunities for tampering along the way.

From the late 1990s until 2000, the FDA typically investigated between four and six counterfeit drug cases a year. But in 2002, the number rose to 22. So far this year thousands of bottles of fake Lipitor were recalled, and patients were found to be injecting bogus versions of the anemia drugs Procrit and Epogen and fake Neupogen. Although no deaths have been directly attributed to the impostor medications, the fakes pose a decided risk to patients.

This uptick in counterfeits has prompted the FDA to fight back, and the task force report is the agency's first draft of a comprehensive plan to attack the issue. An Oct. 15 public meeting was also scheduled to discuss issues surrounding the FDA efforts, with written and electronic comments and suggestions accepted until Nov. 3.