Wednesday, June 19, 2002

BY SUSAN TODD
Star-Ledger Staff

If prescription drugs were labeled like clothes, they might say "Made in Italy" or "Made in India," or in Mexico or in Hungary.

For more than five decades, the pharmaceutical industry has reduced its manufacturing costs by relying on foreign companies to produce key ingredients for its medicines.

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The practice, regulated by the Food and Drug Administration, is widespread throughout the industry, according to drug manufacturing experts. Nearly 80 percent of the main ingredients -- known as active pharmaceutical ingredients -- in medicines come from overseas sources, said Ken Reid, editor of the Inspection Monitor, which reports on the FDA.

For example, the main ingredient for Naproxen, a popular generic drug for rheumatoid arthritis, is imported from factories in Italy and India. A generic Prozac, known as Fluoxetine, is produced in Spain, Italy and India and then shipped to the United States.

"Almost every pharmaceutical company has one or two products that they use a foreign supplier," said Peter Reichertz, a lawyer in Washington, D.C., who works with U.S. drug makers.

But while Europe is still a leading supplier of ingredients, what is new is a shift to chemical companies in countries with less sophisticated and less stringent manufacturing regulations, experts said.

"More and more ingredients are coming from places like China and India," Reichertz said.

Those are places where U.S. regulators and companies face challenges in monitoring production, experts said.

To be sure, the FDA requires foreign factories to pass muster. Companies must register with the FDA and must be able to meet federal manufacturing guidelines known as Good Manufacturing Practices.

Regulators require pharmaceutical companies to identify their suppliers as soon as they file an application indicating they have a new drug to make. In a separate document, the foreign supplier must provide the FDA with a snapshot of its business.

The FDA conducts an initial inspection of the factory and returns every two to three years to make another review, according to Reichertz and other people familiar with the inspection process. The drug companies, meanwhile, must audit foreign suppliers to ensure they are abiding by federal manufacturing standards.

But the long-distance monitoring has raised questions.

"In general, all of these things are done because it costs less in other countries," said Sidney Wolfe of the Public Citizens Health Research Group. "The question is, does it have the same safety standards? Generally it doesn't."

"We don't have major reservations about getting active ingredients from plants overseas because the (FDA) must inspect those plants," said Jeff Trewhitt, a spokesman for Pharmaceutical Research and Manufacturers of American, an industry group based in Washington, D.C.

But some say the industry depends too heavily on the FDA to monitor the companies.

Saundra Granade, a Georgia-based consultant to the pharmaceutical industry, said the responsibility for quality and safety shouldn't rest with the federal agency alone. "It's up to the company to put standards in place that ensure consistency from batch to batch to batch," Granade said.

Vincent Ursino, president of Chatham-based Vinchem Inc., has a bird's-eye view of the business. Vinchem is a middleman, helping drug makers find reputable foreign suppliers.

"We make sure that our FDA consultants go there and spend time to make sure (the plants are) FDA-eligible," Ursino said.

A few years ago, Ursino said, his son toured 20 companies in India that had filed documents with federal regulators indicating they wanted to be suppliers. After inspecting the companies, Vinchem agreed to work with just three, Ursino said.

Susan Todd can be reached at stodd@starledger.com or (973) 392-4125.