Bill would give FDA the muscle to stop fake drugs

With the rise of prescription drug prices, counterfeiting will be an ongoing problem, experts predict.

By Joel B. Finkelstein, AMNews staff. Nov. 3, 2003.

Washington -- The sale of phony drugs has become a growth industry, forcing both the Food and Drug Administration and pharmaceutical makers to launch anti-counterfeit efforts. Now Congress is weighing in on the problem.

Legislation recently introduced in the House proposes to increase the FDA's authority and resources in combating what industry experts insist is still a modest problem. It would also increase the penalties that can be imposed on counterfeiters.

"Unfortunately, criminals have figured out that they can make a good profit by selling fake drugs," said Rep. Steve Israel (D, N.Y.), the bill's sponsor. "Currently, the federal government doesn't have the power it needs to go after these criminals and keep our prescription drugs safe."

Counterfeiters have increased not only in numbers, but in sophistication, said Susan Winckler, vice president of policy and communications at the American Pharmacists Assn. "If you're doing a great job, you can hold off counterfeiters for about 18 months to two years, which means you have to stay 18 months to two years ahead of them, and bring out the new technology when they're about to counterfeit your old technology."

According to Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, counterfeit drugs in the United States are "a modest problem that could spiral out of control if we allow importation from other countries."

The anti-counterfeit legislation could be affected by the debate over reimported drugs.