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

To: betty moyers who wrote (11265)	7/12/1998 11:12:00 AM
From: James Baker	Read Replies (1) \| Respond to of 23519

betty: 3. I do wonder how Vivus is going to target PCP's now. I thought their FDA approval required Uroligist perscription? Enlightenment please>>>>>>> Betty, Once the FDA approves a drug for US use ANY licensed doc may RX it if he/she so chooses to. Of course they are supposed to be familiar with the indications and contraindications and possible side effects to the medication use. Some docs don't want to bother with any thing that is not easy for them and the patient, even when safe and effective. Jim

To: betty moyers who wrote (11265)	7/12/1998 11:17:00 AM
From: Zebra 365	Read Replies (1) \| Respond to of 23519

<<I do wonder how Vivus is going to target PCP's now. I thought their FDA approval required Uroligist perscription? Enlightenment please.>> Betty I'm sure this issue confuses a lot of people and it's relatively simple to answer. All drugs requiring a prescription are legally classified as "dangerous drugs". This is done on a Federal Level by the FDA. "dangerous drugs" with the potential for abuse are called "Controlled Substances", also known as "scheduled drugs" because there are five schedule levels controlled by the DEA. Marijuana and heroin are schedule 1 drugs and no physician can prescribe them (according to Federal Law) Cocaine is a schedule 2 drug as are amphetamines and powerful narcotics. Anabolic steroids are schedule 2 because of the high potential for abuse. Less powerful narcotics such as Vicodin and codeine cough syrups may be schedule 3 and 4. A physician with an unrestricted license to practice (granted by the State, not the Federal Govt) who also has a DEA license (from the Fed DEA) can prescribe any drug for any purpose. Usually the State also has a license for scheduled drugs in addition to the Federal one, so they can track prescribing activity. If course if you really believe you should be prescribing cocaine as a nasal decongestant, you can expect some attention from your State licensing board as well as the DEA. When the FDA approves a drug it also approves the situation in which the drug should be used. When drugs are prescribed for other than FDA approved situations these are known as "off-label" uses, this is not illegal and is actually pretty common. But a drug manufacturer will get in real trouble with the FDA for promoting off-label uses of their product. Most drug reps are trained to decline even discussing off-label uses with the doctors. Just some terminology for the benefit of all. Zebra