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FDA Warns Roche About Misleading Comments Made by Salesperson Regarding Antiretroviral Fuzeon

July 20, 2005


This article is part of The Body PRO's archive. Because it contains information that may no longer be accurate, this article should only be considered a historical document.

A salesperson from the pharmaceutical company Roche made misleading claims at a November 2004 medical conference about the efficacy of the antiretroviral drug Fuzeon, FDA said in a July 15 letter to the company, Reuters reports (Reuters, 7/18). The Roche sales representative at a Washington, D.C., conference on infectious diseases "misbranded" Fuzeon by suggesting that "100% of patients are susceptible" to the drug, according to the warning letter (Krauskopf, Bergen Record, 7/19). "This claim suggests that the product would be appropriate for a broader range of patients than those for whom it is actually approved," the letter said (Reuters, 7/18). Fuzeon is in a class of drugs called fusion inhibitors and is designed for HIV/AIDS patients who have failed to respond to other medications (Kaiser Daily HIV/AIDS Report, 6/14). In clinical studies, 46% of patients responded to the drug, according to the letter (Corbett Dooren, Dow Jones Newswires, 7/18). The letter also said that the salesperson's claim that Fuzeon, which is administered through injection, is better than oral HIV drugs and "misleadingly suggests that Fuzeon is an alternative to oral HIV drugs, when in fact it is approved in conjunction with such drugs" (Reuters, 7/18). FDA said Roche must stop distributing or using materials similar to the ones the salesperson might have used (Dow Jones Newswires, 7/18). Roche spokesperson Maureen Byrne said the company is "conducting a thorough review" of the claim and will respond to the letter by the July 29 deadline (Reuters, 7/18).

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Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.




This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 

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