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The Star-Ledger Newark, NJ

FDA Watching Drug Makers' Plant Violations


November 20, 2002
Copyright © 2002 The Star-Ledger Newark, NJ. All rights reserved. 

Federal regulators are scrutinizing two New Jersey companies for violations at their manufacturing plants in Puerto Rico, according to information released yesterday by the Food and Drug Administration.

Bristol-Myers Squibb and Becton Dickinson are working with regulators to correct problems in separate plants. In Bristols case, the factory makes cholesterol medicines. Bectons plant produces devices such as specialty needles for performing biopsies and catheters - soft plastic or rubber tubes - for people with bladder problems.

The FDAs warning letters represent the latest examples of compliance problems that have hurt some large drug makers.

Puerto Rico is home to the largest concentration of pharmaceutical factories in the world; 30 companies have plants there.

Three decades ago, the companies moved plants there seeking tax relief, but increasingly they have faced another potentially costly headache: problems meeting FDA regulations, problems investigators believe threaten the quality and safety of their products.

"Some of the compliance issues aren't because people don't know what they're doing, but the new products are undergoing a lot more scrutiny," said Saundra Granade, a drug industry consultant in Georgia. "The heart of the problem is the parent company's compliance direction and compliance attitude."

In an Oct. 23 letter to Peter Dolan, Bristol-Myers' chairman and chief executive, the federal agency expressed dissatisfaction with the company's response to quality control deficiencies identified during inspections in July and August.

The agency said the company's practices are affecting the quality and purity of several drugs: Estrace tablets and Cholestyramine Power, Questran and a generic version of the cholesterol drug.

The drug maker, which employs more than 8,000 people in New Jersey, has a contract to make the products for several other pharmaceutical companies.

Becton Dickinson also received a warning letter Oct. 25 from the FDA detailing violations at its manufacturing plant in Juncos, where the company makes Whitacre specialty needles and other medical devices.

Franklin Lakes-based Becton originally was cited for numerous violations, including a failure to provide workers with enough training to carry out quality control practices and not identifying actions to correct problems with the Whitacre needles.

But in the same letter, the agency said the company's corrective actions "appear to be adequate and will be verified during the next follow-up inspection."

The news weighed down the medical device maker's stock yesterday. Shares closed at $28.85 a share, down nearly 5 percent, or $1.46 a share.

At Bristol-Myers, a spokesman said the company has had multiple meetings with regulators over the problems. The company sent a second letter responding to FDA's findings as recently as last Friday.

"It's a continuing dialogue," spokesman Robert Laverty said.

The FDA has put pharmaceutical companies on notice that it intends to crack down on drug-makers who do not police themselves.

In May, Schering-Plough Corp. paid a $500 million fine as part of a settlement with the FDA over problems at its manufacturing plants in Puerto Rico and New Jersey. The settlement came after 13 inspections turned up violations relating to manufacturing and packaging over a two-year period.

Johnson & Johnson became the subject of an FDA investigation last summer after a former employee criticized practices at its manufacturing plant in Manati. The remarks were contained in a lawsuit, which was put on hold by the agency's investigation.

The worker's complaints attracted renewed attention from government regulators after Eprex, an anemia drug Johnson & Johnson makes at the Manati plant, was blamed for causing a rare blood disease in some patients taking the drug.

A month later, the Justice Department said it would no longer intervene in the court case although it declined to comment on the status of the FDA's investigation.

Shares of Bristol-Myers closed at $24.20 a share, down 1 percent, or 34 cents a share.

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