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Unapproved Drugs Found Rampant in FDA, Customs Mail Inspection
Sept. 29 (Bloomberg) -- The Food and Drug Administration said a spot check of drugs imported into the U.S. found that 88 percent were unapproved and may be unsafe.

The FDA and the U.S. Customs and Border Protection examined 1,153 imported drugs at mail centers in California, New York and Miami in July and August. They found 1,019 of the packages contained unapproved medicines, the FDA said in a statement.

Inspectors found an unapproved version of Roche Holding AG's Accutane acne treatment imported from Thailand and unauthorized lots of the blood-clotting drug warfarin shipped from Canada. In the U.S., patients taking those drugs need to be monitored closely by a doctor to avoid risks, the agency said. Many of the drugs seized didn't have instructions for safe use. Inspectors also found some that had been pulled from the U.S. market.

``We obviously can't screen all these drugs with any regularity,'' said Bill Hubbard, the FDA's associate commissioner for policy and planning. ``We certainly feel and believe that the problem is getting worse.''

Prior estimates were that an average of 2 million packages a year crossed U.S. borders carrying some form of prescription medication. The pharmaceutical industry estimates that figure has doubled in the past 18 months, Hubbard said.

The FDA said it will work with other government agencies to help restrict the use of such imported drugs and continue to educate consumers about the dangers.

``We have only rare and sporadic examples of people getting a foreign drug like this and it being dangerous,'' Hubbard said. Typically, the medicine is inactive and so disease symptoms return, he said.

Most of the unapproved medications came from Canada, India, Thailand and the Philippines, the FDA said.

Last Updated: September 29, 2003 16:47 EDT