Steve Quayle News Alerts

July 16, 2003
By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - Radiofrequency chips, tags on bottles and tamperproof packaging are among the new measures being considered to prevent distribution of counterfeit drugs, the U.S. Food and Drug Administration said on Wednesday.

The FDA, long criticized for turning a blind eye to imported drugs, said it will also more aggressively police drugs coming across borders.

"Americans have the benefit of what has been the safest drug supply in the world and I intend to keep it that way," FDA Commissioner Dr. Mark McClellan told a telephone briefing.

He said he was setting up an FDA task force to look at improvements and would also work with other federal agencies including the Bureau of Immigration and Customs Enforcement, the Bureau of Customs and Border Protection, and the U.S. Secret Service.

The task force will issue an initial report in 60 days and a final report in six months.

While drug counterfeiting is rare in the United States, the problem is enormous in some countries and is growing here, McClellan said.

HIGH-PROFILE CASES

Two high-profile cases of counterfeit drugs this year involved top-selling Lipitor, a cholesterol-lowering medication sold by Pfizer, and Procrit, an anemia drug sold by Johnson & Johnson under a licensing agreement with Amgen Inc .

Up to 200,000 bottles of Lipitor, the world's best-selling medicine, have been recalled by the distributors and the case is still under investigation. The FDA said it appeared the fake Lipitor came from outside the United States.

In June three people pleaded guilty to charges they sold fake versions of Procrit. The counterfeit bottles contained water contaminated with bacteria, the FDA said -- putting the cancer and AIDS patients who use it at risk of a blood infection.

"To our knowledge there have been no fatalities related to the consumption of counterfeit drugs, at least in recent years," McClellan said.

But in June the House Oversight and Investigations Subcommittee ripped the FDA for not aggressively policing the import of prescription drugs.

Subcommittee Chairman Rep. Jim Greenwood, a Pennsylvania Republican, said about 60 million pharmaceuticals enter the United States through mail annually, an increase of 1,000 percent since 2001. Little is done to police such imports.

The FDA did not say what it would do to more closely watch mail imports but noted the problem.

McClellan said some ideas already being discussed include better labeling.

"It is important to point out that improvements in labeling by themselves need to be inextricably linked to the product," he said, noting that new labels do little good if pills, for instance, can simply be dumped and replaced.

Another idea is to use radiofrequency technology to allow packages of drugs to be tracked. "This a technology that companies like Wal-Mart are starting to use in the coming year already," McClellan said.

"We going to work on an even better alert system," he added. "We are going to strengthen and make our distribution system more secure."

Patient education will also be part of the initiative, McClellan said. Anyone taking a drug should look carefully at the drug itself and the packaging and alert the pharmacist or doctor immediately if it looks, smells or tastes funny, or if an injection feels different.

Higher penalties may also be considered. "For example, the current penalty for counterfeiting a drug label is 10 years in prison, but for counterfeiting the actual drug may only be 3 years," the FDA said.

http://story.news.yahoo.com/news?tmpl=story&cid=571&ncid=751&e=1&u=/nm/20030716/hl_nm/health_counterfeits_dc