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FDA Finds Hundreds of Unapproved Drug Imports
Mon Sep 29, 6:33 PM ET Add Top Stories - Reuters to My Yahoo!

By Lisa Richwine

WASHINGTON (Reuters) - Recent inspections turned up hundreds of potentially dangerous prescription drug imports as Americans sought cheaper medicines from abroad, U.S. health officials said Monday.

Of 1,153 packages intercepted, 88 percent, or 1,019, contained unapproved versions of medicines that may present a health risk, the Food and Drug Administration (news - web sites) said.

The products included unauthorized versions of Pfizer Inc.'s cholesterol-lowering drug Lipitor (news - web sites), controlled substances such as codeine and anabolic steroids, one medicine that was pulled from the U.S. market for safety reasons and animal drugs not approved for human use.

In many cases, the medicines were shipped from developing countries that have no FDA-approved manufacturing plants, officials said.

Lawmakers who are working to create a legal system for importing drugs from Canada and some other countries have accused the FDA of exaggerating the safety risk. Some suggest the agency is pushing the agenda of the drug industry, which is vigorously fighting drug importation.

"For more than two months, FDA Commissioner Mark McClellan and his senior leadership have tried to undermine a legislative initiative the American people desperately want and need," Rep. Gil Gutknecht (news, bio, voting record), a Minnesota Republican who wrote a drug-import bill that passed the House in July, said in a statement on Monday.

"The FDA's actions are all too predictable and pathetic," Gutknecht said.

FDA officials said the recent inspections were designed to gauge the extent of importing into the United States and the proportion that may be dangerous.

The largest supplier of medicines was Canada, followed by India, Thailand and the Philippines. More than half of all the imports came from those countries, FDA officials said.

"We certainly feel and believe the problem is getting worse," William Hubbard, FDA associate commissioner for policy and planning, told reporters during a conference call.

The FDA repeatedly has warned that buying drugs from foreign sources, particularly over the Internet, is risky. Medicines may be fake, ineffective or contaminated, officials say.

The FDA has discouraged drug importing, but has not pursued legal action against patients. Instead, officials have targeted businesses that help people buy medicines from abroad.

But with drug prices rising, more patients are turning to imports and Congress is working to create a legal system for importing medicines from Canada and possibly some other countries. A handful of states also is exploring buying lower-cost medicines from Canada.

The FDA inspections involved spot checks during July and August at mail facilities in Miami, New York, San Francisco and Carson, California. The government detained the products deemed to be illegal and notified recipients, officials said.

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