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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)
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To: Edderd who wrote (21412)4/26/1999 7:23:00 PM
From: Zebra 365  Read Replies (2) of 23519
 
<<Did these people violate some laws by using humans before animal trials? Is this tolerated by the FDA? Something amiss here.
Ed >>

Ed,

Now I know for sure you are a urologist as you brought up a point I have made before that I think that, so far as preventing insertional pain caused by clumsiness, the MUSE applicator should have a more blunt tip, probably larger.

As far as trials of a topical application. and legal permutations. Do you think that the FDA has had to pass on "Oil of Olay" for wrinkles, or all of the latex sex toys out there? It comes down to this, the FDA regulates dangerous drugs, OTC drugs (which claim to diagnose or treat a medical condition), and foods. Now Saw Palmetto is being promoted for BPH but not regulated by the FDA. Why? Because it is considered a "dietary supplement" and therefore exempt under a law passed in 1994.

A cream or gel to enhance sexual arousal would probably not have to pass FDA as a "drug" if it were promoted as a "sex toy" and not designed to "diagnose or treat a medical condition". The Consumer Product Safety Commission might get involved if there were safety considerations, but a lot of vibrator-related ER visits have been made (you know who you are out there reading this now) and vibrators are still not regulated as "medical devices". Ergo, testing of such a substance would not violate any law.

Also there actually are few State laws regulating experimenting on humans as long as there in informed consent. All public institutions and most private ones have policies and procedures and usually a committee to evaluate proposed research on humans (obviously a significant liability issue if harm is done.)

Brainflash, "Oil of Ole!" for the name? nahhh.

Zebra
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