become an OTC remedy? What changes??
The FDA determines that the drug is safe enough to be taken without the immediate supervision of a physician.
Well, how is this “determination point” arrived at? Is there a certain # of years the drug has to be on the market? Is there a certain number of prescriptions that must be filled? Does the manufacturer request this change or does the FDA just decide to make it OTC on its own?
The manufacturer can request the change or the FDA can. Sometimes insurance companies request the change such as the recent case with Claritin - it helps them since they don’t pay for OTC drugs. Financial issues can make a drug company request it go to OTC as well.
Many common drugs started out as prescription - Tylenol, Advil, Sudafed, Actifed, Benadryl are just some examples.
As an aside, does anyone know how much prices for drugs tend to drop when they become OTC? I’m guessing that this is due to economies of scale and such (I don’t know how many more people buy the popular allergy meds that have recently become OTC, but I’d guess its far, far more than bothered to see a doctor and get a script).
The price drop may not be that much , at least at first. When Claritin went OTC I think it was about $1 a pill but it may be cheaper now. The price drop will be more if the patent also expires which means any company can make it.