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Biotech / Medical : PRCY - ANY BODY HAS ANY NEWS ON THESE

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To: larry larsen who wrote (352)4/30/1998 10:45:00 AM
From: Peter H. Proctor  Read Replies (1) of 670
 
" But, what are you referring to re: *in 44 liquormart* and Supreme Court rulings? "

The rules have changed WRT the FDA's ability to prevent "true" drug claims, particularly for agents that are currently "legal products". This includes cosmetic formulations ( Procyute just bought a private label manufacturer ) and off-label uses for approved drugs. E.g., Months before Merck got FDA-approval for Finasteride as a hair-growth remedy, they were out wining and dining docs ( including me ) promoting this off-label use.

My understanding is that now the FDA has to jump thru hoops, have their officials sit for depositions ( the unkindest blow of all ), etc. BTW, the ex-FDA commissoner David Kessler actually refused a court order to sit for a deposition in a related case ( WLF v. Kessler ). None of these guys wants to be put to the question under oath.

No more arbitrary decisions made behind closed doors. About time too. The drug firms seem to have figured this out and are acting accordingly, tho nobody seems to be making a big deal about it. Don't ask, don't tell, etc.

Dr. P
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