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U.S. steps up checks of foreign drugmakers Imports often fail to meet FDA standards


WASHINGTON -- As the American medical system rushes to control costs, imports of discount drugs and their ingredients are rising. And that is causing concern about how well foreign manufacturers meet American standards aimed at preventing toxic contamination and poor quality.

Over the past three years the Food and Drug Administration has doubled the number of its inspections at foreign plants, and it has been rejecting or detaining more products.

In the past year alone, the agency has found serious manufacturing deficiencies, from contaminated water supplies to lax quality controls, in 35 percent of its overseas inspections, in countries as varied as Switzerland and China, compared with 19 percent at domestic plants.

But policing this far-flung trade is daunting, given the barriers of language and distance. Interviews and a review of dozens of FDA documents raise questions about whether the agency, known as a tough regulator at home, will be able to keep defective drugs from slipping through.

Top FDA officials and other drug experts say that they are confident that nearly all imported products reaching consumers

are safe and effective and that there is little chance an individual will receive tainted drugs. But concern is rising as pharmaceutical companies, under pressure to help control medical costs, increasingly look to lower-priced suppliers abroad.

And more foreign pharmaceutical companies have begun to sell finished drugs in the huge U.S. market.

The safety concerns are "a legitimate worry," said William F. Haddad, chairman of Mir Pharmaceutical Inc. in Brewster, N.Y., and the head of the international committee of the Generic Pharmaceutical Industry Association. "I'm not so sure FDA has the manpower. The trade is expanding quicker than their ability to respond to it."

Ronald G. Chesemore, the FDA's associate commissioner for regulatory affairs, said top agency officials felt that "we've done a tremendous job of beefing up the foreign inspection program" and that American consumers remained safe.

The agency has increased the number of foreign companies inspected to 325 this year from 156 in fiscal 1992, and it is $H training agents better and increasing the length of the inspections, he said.

But James G. Phillips, a former special assistant to FDA Commissioner David Kessler, who examined the program before left the agency a year ago, said, "This thing is like a ticking time bomb that could explode at any time."

An episode at one Canadian plant illustrates the problems. In 1991, an anonymous warning arrived in the mail at the FDA's headquarters. Neatly typed, it came from a "fed-up employee" at Novopharm Ltd., a Canadian company that makes discount generic drugs.

The letter said raw batches of some of the company's products did not always "work the way they are supposed to."

The tipster also indicated that the company might have shipped bad products to the United States, including batches of a children's antibiotic that were too potent and could possibly destroy bacteria that might help, as well as those that might harm, an ill child.

The letter bounced around the FDA. When the agency finally sent inspectors to the plant 10 months later, they confirmed that some of the blending processes had once been, to use the words of an FDA memo, "out of control."

Company officials told the FDA that they felt certain that they had detained the bad batches at the plant and that no Americans were harmed, but they agreed to quit shipping the antibiotic to the United States temporarily.

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