Federal crackdown targets bogus copies of popular drugs

The FDA is devising a plan to halt the influx of counterfeit medicines.

By Susan J. Landers, AMNews staff. Aug. 25, 2003.

Washington -- Skillfully crafted counterfeits of certain best-selling drugs have turned up in pharmacies across the nation as unscrupulous suppliers find that these fakes have considerable street value.

Thousands of bottles of fake Lipitor were recalled in May and June. Patients also have been found to be injecting bogus versions of anemia drugs Procrit and Epogen and fake Neupogen. And, although no fatalities have been linked to the counterfeits, the pattern is viewed as a threat to patient health.

That's why physicians likely will play an important role in a new Food and Drug Administration initiative to identify such shams.

From the late 1990s until 2000, the FDA typically investigated between four and six of these cases a year. But in 2002, the number rose to 22. This uptick prompted the agency to announce July 16 its initiative to combat counterfeits. It also will assemble an internal task force on the subject. Preliminary findings are expected next month.

"The sole purpose of this initiative is to develop new and innovative ways to make sure that Americans can continue to have confidence that the drugs they buy are, in fact, the real deal," said FDA Commissioner Mark B. McClellan, MD, PhD.

But even before the specific marching orders are unveiled, patients and physicians should be vigilant. Although the nation's pharmaceuticals are among the world's safest, they are not invulnerable to tampering. And a patient's inexplicable failure to respond to a medication could be a signal that the bottle in the medicine cabinet does not contain the real thing.