Abstract
Rx to over-the-counter (OTC) switch is a data-driven, scientifically rigorous, and highly regulated process that allows consumers to have OTC access to a growing range of medicines. Patients often approach a pharmacist instead of a Healthcare Professional for minor illnesses such as fever, aches, nausea, allergies, cough, and cold. Switches are a logical extension for life-cycle management of a product to defense originator company from Generic competitors. The driving factors required for switching are self-diagnosis, self-medication, and self-administration. On increasing of Rx to OTC switching relatively rules and regulations governing are also improving. Label instructions have to be simple and easily understandable by ordinary people by preventing medication errors and drug abuse. Labeling must include indications, warnings, and directions for use especially since they are administered without medical guidance. Adding a graphic description on the label may be useful to patients, mostly illiterate individuals (e.g., Drug Facts Labeling). The advertisement may also influence patients’ decisions on the selection of OTC products. Medicine advertisements should be closely monitored to ensure that they are truthful and are not misleading or unfair. In this respect, it is recommended that advertisements reflect the information that is contained in the product information leaflet, which, in turn, should be unbiased, evidence-based, and presented in a clear, understandable, and easily readable way. This article elaborates on regulatory requirements, challenges, and marketing aspects of Rx to OTC Switching medicinal products.
Highlights
Over-the-counter (OTC) drugs are generally disposed to consumers without a need for a prescription from a health-care provider
When drug manufacturers are prepared for switching their medications from prescription to OTC, three main factors must be considered such as benefit-risk comparison, consumer-friendly labeling, and how to consider the drug a right choice as an alternative to prescription medication [2]
In case the FDA deems that the clinical data submitted along with the application is “sufficient to justify the OTC switch” [25] the sponsor can avail 3 years of marketing exclusivity under the Hatch Waxman Act when the results of the trials “have not been relied on already approved drugs to demonstrate substantial evidence of the effectiveness for any indication for a new patient population”[26]
Summary
Over-the-counter (OTC) drugs are generally disposed to consumers without a need for a prescription from a health-care provider. An OTC monograph is a “rule book” for each therapeutic category containing active pharmaceutical ingredients, uses (indications), doses, labeling, and testing at which OTC drug is generally recognized as safe and effective, marketed irrelevant to NDA and FDA pre-market approval [21]. In case the FDA deems that the clinical data submitted along with the application is “sufficient to justify the OTC switch” [25] the sponsor can avail 3 years of marketing exclusivity under the Hatch Waxman Act when the results of the trials “have not been relied on already approved drugs to demonstrate substantial evidence of the effectiveness for any indication for a new patient population”[26].
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