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FDA Says Most Drug Imports in Recent Sweep May Be Unsafe

BY Admin  September 30, 2003 at 3:22 PM EDT

The agency is under pressure from lawmakers who say allowing some reimportation of drugs from abroad would help Americans struggling to pay for expensive medicines.

“Given FDA’s limited resources and authorities to detect and block potentially unsafe imports, we are concerned about any measures that would increase the flow of these unapproved drugs, or provide easier channels for them to enter the United States,” FDA Commissioner Mark McClellan said at Monday’s release of the report.

Of 1,153 packages collected by FDA and customs agents, 1,019 contained unapproved drugs. Some of the packages contained drugs that have been withdrawn from the U.S. market, animal drugs never approved for human use, drugs with dangerous interactions, drugs requiring monitoring by a doctor and narcotics, the FDA reported.

The FDA did not perform tests to chemically determine whether the intercepted drugs were safe, FDA Associate Commissioner William Hubbard told the Online NewsHour.

Drugs from Canada accounted for 15.8 percent of those stopped during the investigation. Close behind was India, the source of 14.3 percent of intercepted packages, followed by Thailand with 13.8 percent and the Philippines with 8.0 percent. The country of origin was the only criteria used to determine whether a package would be inspected. Other countries whose packages were searched were Brazil, China, Peru, Mexico, Fiji, the United Kingdom and Costa Rica.

The possible legalization of buying drugs from pharmacies in other countries has been in the spotlight recently. In July, the House passed a bill that would allow the reimportation of drugs from approved industrialized countries, including much of Europe, Canada and South Africa. These countries have various means of regulating drug prices that leads to generally significantly lower prices than in the United States.

Rep. Gil Gutknecht (R-Minn.), who sponsored the bill to ease drug reimportation rules, said the FDA is trying “to undermine a legislative initiative the American people desperately want and need.”

“Would anyone at the FDA seriously propose that the only way to ensure the safety of imported food is to ban importation?” Gutknecht asked.

About one-quarter of the drugs found in the FDA’s recent crackdown would have been legal under that bill, Hubbard said. Even though those drugs came from countries covered in the legislation, the FDA would still have concerns about the safety of those drugs. Specifically, the agency would be worried that the drugs might have a return address label from an approved country even if they were actually from a country not authorized by the bill, Hubbard cautioned.

Foreign governments do not take responsibility for the safety or quality of products shipped to U.S. consumers, and the FDA cannot guarantee the safety of drugs made in plants it doesn’t supervise, Hubbard said.

Some of the unapproved drugs found in the inspections were generic versions of drugs approved in the United States, but since the generic versions were manufactured abroad and approved by foreign governments, the FDA could not guarantee that the drugs were safe.

The FDA reported that this blitz uncovered more imported drugs than a similar analysis done in 2001.

“We certainly feel and believe the problem is getting worse,” Hubbard told reporters during a conference call.

The drugs were collected at international mail arrival centers in New York, Miami, San Francisco and Carson, Calif., during three-day periods in July and August.