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Thursday, September 03, 2020 4:48:30 PM
Just throwing this out there for thoughts:
First of al there is a distinction between dietary supplements and OTC products.
DS is regulated like food. You can’t make health claims or “treat” medical conditions
OTC is a non prescription drug. You can put an indication and a dose (though maybe not 4gm therapeutic dose)
OTC would be the way to go but the problem becomes insurance coverage. Generic V would be covered and cheap vs OTC Vascepa being full price vs covered Rx
Tylenol is OTC but can also be prescribed as well and if prescribed then covered by some plans. Same for OTC V? Insurance would cover gV and OTC V. Can they cut the cost by going direct OTC - IDK???
What happens if doc prescribed “OTC V”? If not a “drug” it may not be interchangeable with gV.
Amarin could try and get insurance to cover OTC V and beat the gV price so that insurance preferred OTC V over gV.
As an OTC product they can advertise clinical trial benefits and reference R-it and EVAPORATE. If Dr R tried to copy they couldn’t mention R-it and EVAPORATE.
Another example is Advil. 200 and 400mg are OTC but prescription at 600mg. Pts buy OTC 200 and take 3 if cheaper (no dispensing fee). OTC V could be 1g caps advertised as 2g/day (non therapeutic dose) OR AS RECOMMENDED BY YOUR DOCTOR.
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