U.S. Sample Finds Drug Imports Unapproved, Risky

Thursday, January 29th 2004

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A new inspection of medicines coming to the United States from abroad found most contained unapproved versions of drugs that were potentially risky, U.S. officials said on Tuesday.

The Food and Drug Administration said the findings provided evidence that buying prescription drugs from foreign sources is risky, an argument critics doubt.

Many Americans have bought medicines from other countries, particularly Canada, where many drugs are cheaper even though the practice is illegal in most cases.

"We found much for consumers to be wary about," FDA Commissioner Mark McClellan told reporters.

FDA and U.S. Customs Service inspectors examined more than 1,000 packages containing more than 1,700 products at mail facilities and courier hubs in November.

Nearly all of the medicines were unapproved for sale in the United States, McClellan said.

For many of the products, U.S.-approved versions exist. But the ones crossing the border often lacked proper packaging or the U.S.-mandated labels that carry important safety warnings, FDA officials said.

Some packages had no instructions at all, while others displayed directions in foreign languages, the agency said. Several medicines were shipped loose in plastic bags or wrapped in tissue paper.

The inspections also turned up controlled substances, such as codeine and medicines requiring physician monitoring, the FDA said. Some parcels contained asthma medicines that recently had been recalled in Canada because certain lots were defective and might deliver too little of the drug.

About 80 percent of the packages came from Canada and about 16 percent from Mexico. The rest were exported from Japan, the Netherlands, Taiwan, Thailand and the United Kingdom.

Supporters of drug importing have said they disagree medicines bought in Canada are any less safe than ones sold in U.S. pharmacies. They have charged the FDA with simply trying to protect drug makers' profits, which agency officials deny.

Springfield, Massachusetts, and Montgomery, Alabama, have drug import programs for city workers and retirees. Twenty-five states and fifteen localities are looking into the idea, drug industry lobbyists said last week.

The FDA's recent inspections were performed at mail facilities in Buffalo, Dallas, Chicago and Seattle, and courier hubs in Memphis and Cincinnati.

Last September the FDA said an inspection of packages sent to a California mail facility found 88 percent of the parcels inspected contained unapproved medicines.

Lisa Richwine Reuters News 28 January 2004

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