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Healthy Skepticism Library item: 8600

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Gold J.
Ranbaxy Says FDA Searched Offices, Lab
Associated Press 2007 Feb 15
http://biz.yahoo.com/ap/070215/ranbaxy_searches.html?.v=2


Full text:

NEWARK, N.J. (AP) — U.S.-based subsidiaries of generic drug developer Ranbaxy Laboratories Ltd. of India said Thursday that federal agents have searched their offices and manufacturing facility in New Jersey.

Paper and electronic documents were taken in the raids, conducted primarily by the Food and Drug Administration, said Chuck Caprariello, vice president of corporate communications and government affairs for Ranbaxy Inc.

The searches took place throughout Wednesday at Ranbaxy’s North American headquarters in Plainsboro and a manufacturing facility in New Brunswick, Ohm Laboratories, which is also a subsidiary of the parent company, Caprariello said.

“We’re cooperating and providing them with (material) even today,” he said.

Caprariello said the searches were a surprise and that the warrant did not appear to indicate what agents were interested in.

“Our counsel told us it was very vague,” he said. He said a copy could not immediately be provided.

FDA spokeswoman Cathy McDermott referred inquiries to the Justice Department, where spokeswoman Marsha Murphy said, “We don’t comment on ongoing investigations.”

Ranbaxy, India’s largest pharmaceutical, has been operating in the United States since 1995 and has approvals to make 119 drugs, about 40 of which are produced at Ohm Laboratories, he said. The rest are made in India.

Ranbaxy is one of the world’s top 10 generic drug producers. It bought three European companies last year, and now operates in 25 countries across the world, but the United States accounts for the bulk of its global sales.

Ranbaxy, based outside New Delhi in Gurgaon, last month got FDA approval to make a generic version of Zoloft, a blockbuster antidepressant made by Pfizer Inc. Other generic makers already had approval for generic versions.

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963