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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Jman who wrote (6808)	4/10/1998 2:32:00 PM
From: BigKNY3	Read Replies (1) of 23519

Jman <<BigKNY3,I am not a bio expert, but can you explain to me why the FDA would approve a label and the print/TV ads, and then later, after they are in production, ask for revisions/changes (I believe this is happening to Vivus). Isn't that the idea of FDA approval - that what they approve is ok to do?>> The approved package insert is the basis for all promotional and educational materials. Everything in an journal ad, tv ad or visual aid must be referenced to an indication and safety profile that was reviewed by the FDA. Now, comes the gray area....such as the MUSE TV ad. What the company considers appropriate to the package insert with a fair balance of efficacy versus adverse reactions may be very different from the FDA viewpoint. The result: a warning letter from the FDA demanding a cease and desist order, immediate revisions and corrective actions. Even though many Pharmas submit and discuss their materials with the FDA prior to release, I doubt this was the case for the MUSE ad. Good investing! BigKNY3

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