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Tablets & Capsules July 2015 29 • Be safe • Be effective • Treat a condition that the patient can recognize and manage without the supervision of a licensed HCP. In the USA, there are more than 300,000 OTC drug products listed and they cover more than 80 therapeutic classes. Most of these products are delivered in oral forms: tablets, capsules, chewables, and liquids. The largest OTC categories include pain relievers, cough- cold-allergy products, gastro-intestinal remedies, women's health drugs, vitamins and nutritional supple- ments, lifestyle treatments (e.g., sleep aids, motion-sick- ness remedies), and dermatological products. About 60 percent of all medication units sold in the US are OTCs, and they play a vital role in the US healthcare system. Generally, consumers like OTC medi- cines because they are easy to get, affordable, and allow individuals to choose. Thus, OTC medicines facilitate the individualization of drug treatment because con- sumers can try out what product or treatment option works best for them. Data from early 2014 show that 240 million Americans use OTC medicines [2]. OTC brands are broadly distributed in the US, primarily through pharmacies, supermarkets, and club and conve- nience stores, but they are potentially available from more than 750,000 retail outlets across the nation. Annual retail sales of OTC medicines exceed $29 billion and are growing 3 percent per year [3]. Table 1 lists the top 10 OTC brands by sales revenue. Nevertheless, under-treatment of common diseases remains a problem in the USA due to under-insurance, the cost of medical care and treatments, and limited access to care. In fact, many Americans lack easy access to basic medical treatment. That may be an important factor in the reported under-treatment of many common chronic health disorders and the associated negative impact on public health (individual suffering, societal costs) [4]. OTC drugs help bridge this gap, providing more options to satisfy Americans' basic healthcare needs. Without access to OTC drugs, 60 million Americans would not seek treatment for their illnesses [5]. Improving consumer access to medicines More than 100 active pharmaceutical ingredients (APIs), strengths, or indications that were available only by prescription became available OTC over the last 40 years. As a result, consumers have unlimited access to a variety of well known brands, including Advil, Aleve, Allegra, Claritin, Mucinex, Nicorette, Prilosec OTC, and Zyrtec. Switching a proven Rx drug to OTC status entails engaging a highly regulated, data-driven, and rigorous approval process that is led by the FDA [6]. To begin, the product must be shown effective and safe—without the risk for misuse, abuse, or dependence—and employ clear labeling language that ensures consumers will use it prop- erly without direction from a physician or other HCPs. Furthermore, consumers must be able to adequately rec- ognize their own medical condition without the interven- tion of a learned intermediary (e.g., an HCP) [7]. To that end, the FDA created the "Drug Facts" label, which gives consumers easy access to important information about an OTC drug, such as its API(s), directions for use, and warnings. This enables appropriate self-selection. Rx-to-OTC switches are an important business driver in the OTC industry, opening up new treatment cate- gories and new classes of drugs, brands, and technologies to give consumers more choice in managing and improv- ing their health. In 2014, the FDA approved two Rx-to- OTC switches (Flonase Allergy Relief and Nexium 24HR) in two different but established OTC categories. In fact, two Rx-to-OTC approvals per year has roughly been the average since 2000. Part of lifecycle management strategy A pharmaceutical company will often consider switch- ing an Rx drug to optimize its product lifecycle. The product could be a heritage brand managed by an affili- ated prescription drug company, or it could be a licensed product from another prescription drug company that lacks the resources to switch or is not interested in OTC medications. Frequently, Rx-to-OTC switches take place as a drug product nears its patent expiration, and has suf- ficient market exposure and favorable safety data to make it a good candidate for OTC status. But in recent years, sponsors have begun planning to switch some or all of the Rx indications to OTC status ear- lier in the product lifecycle. This strategy often requires companies to plan for the switch while the program for a new Rx product is in development. It may even encompass considering OTC-type packaging design and convenient product handling during the design of the Rx product in anticipation of the patient becoming a retail consumer (e.g., Veramyst, an Rx that has not yet switched). In so doing, the manufacturer may be able to obtain 3 years of Hatch-Waxman exclusivity (i.e., added patent life) for the OTC product if it requires additional clinical studies. It Table 1 Top 10 OTC brands by sales revenue (millions of dollars) [2]. Boldfaced brands are Rx-to-OTC switches. 1. Advil 720.1 2. Nature Made 680.8 3. Mucinex 584.8 4. Tylenol 518.2 5. Vicks 485.7 6. Nature's Bounty 423.5 7. Claritin 408.7 8. Aleve 357.3 9. Zyrtec 325.7 10. Centrum 313.9 All OTCs 29,539