Drug import crackdown criticized

Lawmakers say FDA aim is to aid U.S. industry, not protect consumers


WASHINGTON -- Drug industry experts and a bipartisan group of legislators in the House of Representatives say the Food and Drug Administration's campaign against importing prescription drugs is intended more to help the drug industry than to protect public health.

They accuse the FDA of overstating the health hazards of foreign drugs to help the drug industry defeat legislation legalizing the purchase, or "re-importation," of U.S.-made drugs from Canada and 24 other countries where drugs are less expensive than they are in the United States.

FDA officials deny the allegations, saying they intend only to protect public health.

The proposal is part of Medicare legislation being crafted by House and Senate negotiators. Lawmakers hope to give final approval by year's end.

The FDA has criticized drug re-importation on these grounds before; the latest flap stems from its seizure in August of 1,019 non-FDA-approved drugs during a series of random package checks at mail facilities around the country. The drugs, presumably purchased online, had been shipped from foreign countries to customers in the United States.

Although the FDA's intent to conduct such searches was discussed at hearings this summer, many observers are skeptical because the inspections were conducted as the drug industry's trade group, the Pharmaceutical Research and Manufacturers of America, was beginning a major advertising campaign stressing the health risks of foreign drugs.

Drug makers oppose importing drugs from other countries because they would lose billions of dollars if U.S. customers were allowed to buy drugs at discounted prices. Americans pay the highest prescription-drug costs in the world.

In addition to unapproved drugs, the FDA search found drugs with improper labeling, poor packaging and other FDA violations. The operation "illustrates the real and serious public health risks" of imported drugs, FDA Commissioner Mark McClellan said at the time. The FDA also opposes re-importation because it can't guarantee the safety of drugs that aren't manufactured, stored and distributed under its guidelines.

"Our biggest fear is that the quality of drugs people buy from this sort of importation is low already and would get much lower," said William Hubbard, an FDA senior associate commissioner.

Hubbard said the agency wasn't in cahoots with drug makers. "There's nothing nefarious here," he said of the sting operation.

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