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发表于 2002-3-31 06:41
Tuesday March 26, 3:26 pm Eastern Time
Reuters
FDA calls Gilead's Viread sales tactics misleading
By Deena Beasley
LOS ANGELES, March 26 (Reuters) - The U.S. Food and Drug Administration has ordered Gilead Sciences Inc. <GILD.O> to stop making exaggerated claims about its AIDS drug Viread, including pitching it as a ``miracle drug.''
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In a recently released letter, the FDA said the biotechnology company violated federal law at a December medical meeting when sales representatives made false and misleading statements to FDA reviewers, including suggesting that a warning on Viread's label about the risks of liver enlargement was not valid.
A spokeswoman for Foster City, California-based Gilead said on Tuesday the company takes the FDA's comments very seriously and is working to identify the individuals that may have been involved. ``We have strict policies and training procedures about this sort of thing,'' said spokeswoman Amy Flood.
Viread, a once-daily tablet, was approved by the FDA in October for use in combination with other drugs to treat patients infected with HIV. It is the first drug in a class known as nucleotides approved for fighting the virus. Nucleotides are chemically similar to nucleosides, the best-selling antiretroviral drugs. Both types work by blocking reverse transcriptase, an enzyme involved in the replication of HIV.
At the Interscience Conference on Antimicrobial Agents and Chemotherapy held in Chicago, Gilead representatives made statements that ``overstate the efficacy of Viread and fail to communicate material facts with respect to the limitations of the indication,'' the FDA said in its warning letter.
The agency told Gilead to stop making the statements, stop distributing any promotional literature that contains such statements, and respond to the letter in writing.
Flood said the company has already sent a response to the agency and its promotional literature has never contained the statements detailed in the FDA letter.
Shares of Gilead, which specializes in developing drugs for infectious diseases, were up 27 cents at $36.48 late Tuesday on Nasdaq.
The company recently submitted applications to the FDA and European regulators for its experimental drug adefovir as a treatment for hepatitis B. The FDA in 1999 rejected an application for adefovir as an AIDS treatment, citing concerns about kidney toxicity.
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Anyhooz,there is a hawaiian singer, Hoku (it means STAR)..I posted one of her songs on HAPPY ENGLISH b4..it was that song, "How do I feel.." U know..
"How do I feel ever since I walked away from u.
I miss u for real.
Everyday of my life."
Anyhooz, gotta fly!
Peace and Love
~*Butterfly~