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FDA Says Hoffmann-La Roche Made Misleading Claims About HIV Drug

Posted on: Tuesday, 19 July 2005, 12:01 CDT

Jul. 19--A sales representative at Hoffmann-La Roche Inc. inappropriately promoted its HIV drug at a medical conference last fall, the Food and Drug Administration said Monday.

In a letter to the Nutley-based drug maker posted on the FDA's Web site, the agency said the sales rep "misbranded" Fuzeon by suggesting broader use of the drug beyond what it is approved for.

The agency called on Roche to cease any similar promotions and respond to its concerns by July 29.

"Untitled" letters such as the one sent to Roche contain violations that are less serious than those in so-called warning letters, in which the agency demands corrective action. The letters can be the basis for eventual enforcement action.

Maureen Byrne, a Roche spokeswoman, said the company received the letter Friday and was reviewing it.

"Of course, we take these matters very seriously," Byrne said.

The sales rep's comments came in November at a company promotional booth at a conference in Washington.

Drug companies can make promotional claims for their products only if they are backed up by their FDA-approved prescribing labels.

Fuzeon, which is injected, is the first in a new class of anti-HIV drugs called fusion inhibitors. Roche sold about $80 million of Fuzeon in the U.S. last year.

According to the FDA, the sales representative said that "100 [percent] of patients are susceptible to Fuzeon." That claim, the FDA said, "suggests that the product would be appropriate for a broader range of patients than those for whom it is actually approved."

The representative also claimed Fuzeon was "better than oral HIV drugs" -- which, the agency said, misleadingly suggests Fuzeon is an alternative to oral HIV drugs, when it is approved for use with them.

Separately Monday, Roche said the FDA had accepted an application to sell a needle-free device to administer Fuzeon. Roche said it expects to hear from the FDA about its application later this year.

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Source: The Record - Hackensack, New Jersey

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