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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: sailor who wrote (5069)	1/28/1998 9:13:00 AM
From: Zebra 365	Read Replies (1) \| Respond to of 23519

Re: FDA Plant inspection and approval This does confuse people not familiar with the process. The FDA is not only charged with approving drugs and treatments but also seeing that what is delivered for public consumption is what they approved. Therefor, just because you SAY that the package delivers 500 micrograms of Alprostadil in a sterile fashion is not enough. The FDA makes you PROVE that your package does so, and within a +/- 20% bioavailability range. This is why an FDA approved drug cannot be legally distributed in the US unless it comes from an FDA approved manufacturing facility. Incidentally, this is also what I tell my patients who are getting into the "Herbal Food Supplements" which are now being sold as quasi-treatments for a host of medical ailments. Since "food supplements" are not subject to the same FDA scrutiny in production, you really don't know what you are getting in that herbal pill. Even if St. John's Wort works on depression, going from one "50mg" preparation to another may mean an effective dose change of tenfold or greater, simply because there is no standardization. Several years ago there was a surge of cases of deadly "eosinophilia-myalgia syndrome" that was traced to imperfect manufacturing techniques in batches of 5-hydroxy-tryptophan, which was being sold as a "safe and natural" sleeping aid. Again, sold as a "food supplement" to avoid the FDA hassles, there was no FDA oversight on the manufacturing process. Be careful out there. Zebra