I have been involved in over-the-counter (OTC) regulation for over 25 years. I have extensive experience in the OTC Monograph system, switching drugs from Rx to OTC status, and translating Rx labeling to Drug Facts. I have developed OTC labeling for Rx-to-OTC switch products, and have been involved in consumer behavior testing of Drug Facts elements.
The primary communication tool for OTC drug products is the Drug Facts labeling. This applies to physicians as well as consumers. Most of the communication between OTC drug manufacturers and the medical community is passive. Although not all OTC drug products are actively detailed to the medical community, there are a variety of sources in which both the medical community and consumers are educated about OTC drugs. For example, all OTC drugs are registered with the FDA and their labeling is published on DailyMed which is a National Library of Medicine website. Almost all OTC drug products bear a “Question?” section in Drug Facts, which provides a telephone number, and often times a website, to which questions can be addressed to the manufacturers or distributor. If there is a serious medical issue, the FDA can issue alerts on their website and require companies to send out a Doctor Letter. Information about OTC drugs are also disseminated at various medical conferences (commercial booths) and appear in a variety of medical websites (e.g., WebMD, etc.) which are widely available.
