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How does the FDA decide to allow a drug to be available as a over-the-counter once the patent has expired?

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  • 1 decade ago
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    Just a clarification.. whether a patent has expired or not, the FDA can decide to make a medication OTC. The patent is there so that no other generic companies can duplicate and sell the product (whether it is prescription or not).

    Usually the drug company will apply for OTC status if they feel it is a viable option. The FDA will look at many factors, including the trials done on the drug, to make the decision whether the medication is deemed safe for self-medication by patients without the intervention of a medical doctor. Some of these factors include potential long and short-term side effects and whether the condition intended to be treated is not serious enough to warrant physician intervention.

    Source(s): 8 years school, 2 years practising
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  • 1 decade ago

    Agree with the answer from "take your Medicine". Interestingly, one of the arguments used to justify OTC status is that it's OTC in other countries. This argument makes no sense. OTC in Europe actually means Over the counter. You have to go to the Pharmacy (Chemist) and ask for it, it is handed over to you across the counter. The pharmacist will answer any questions and if they think people are using the medication incorrectly, or whatever they will intervene.

    In the US while we use the expression OTC it actually is "Off the shelf". Therefore I believe many of the OTC here in US should not be.

    OTC status nothing to do with patent.

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  • 1 decade ago

    Approval is given when the company making the product has satisfactorily proved to the FDA that the product is safe and effective. There are set standard tests that must be done on sample sizes that produce statistically relevant results. These test must be well documented and the results submitted to the FDA for approval.

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  • coring
    Lv 4
    3 years ago

    LMFAO! Yay, our government at paintings against enormous undesirable Cheerios. attempting to regulate each little thing. i've got no longer examine a Cheerios field, yet they do no longer placed "Statements no longer approved by skill of FDA", or something to that result? i comprehend places like GNC placed that on all their products and the products they sell. I see those complement businesses constantly making claims like that. Why single out Cheerios? Down the line, maximum of those FDA approved drugs finally end up being undesirable on your well being in any case. i could p.c.. Cheerios over an FDA approved drug anyday.

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