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may also be possible to achieve dual status, in which some indications for the product remain in the Rx realm after others are switched to OTC (e.g., Pepcid AC for heart- burn and Pepcid Rx for peptic ulcer disease, etc.). Clinical studies can also give the OTC product a better market introduction by allowing the marketer to make differenti- ated claims versus existing OTC products. Forces driving Rx-to-OTC switches The macro-environment of healthcare is evolving, and several factors—the growing ranks of baby boomers reaching retirement age, an increase in healthcare con- sumption, and a shrinking number of HCPs to provide care—explain why better access to OTC medicines is needed. Indeed, making OTC treatments more accessible meets the need for cost reductions in the healthcare system and meshes with the trend of shifting costs and responsi- bility for people's healthcare to patients/consumers [8]. Another trend is the growing importance of pharma- cists, physician's assistants, and nurses in managing patients with chronic conditions (diabetes, high choles- terol, high blood pressure, etc.). Concurrent to that trend is yet another: Moving some Rx medicines for treating these chronic conditions to OTC status. In this and other ways, Rx-to-OTC switches align with the goals of the Affordable Care Act. In the last two decades, a variety of new OTC drugs, therapeutic categories, and market segments have come from switching an Rx drug to OTC status. They include H2-receptor antagonists and proton pump inhibitors (both Rx anti-ulcer drugs), osmotic laxatives, non-sedating anti- histamines, and nasal steroids. Consider the nicotine- replacement therapies that help consumers quit smoking. When switched to OTC status, sales nearly doubled in the first year [8, 9]. In addition, a number of switched brands have become leaders within their segments, and some rank among the top 25 drugs within the entire OTC market. The complexity of switches Improving the probability that an Rx product can be switched into a new category of OTC status may require a wide circle of stakeholders beyond the FDA team, including technology experts, pharmacists, physicians, consumers, retailers, and payers. This is especially impor- tant when the switch would be the first drug in a thera- peutic class (e.g., Oxytrol for overactive bladder, Figure 1) or when it engenders controversy (Plan B contracep- tives). In such cases, resistance must be met with scien- tific data and persuasive arguments. The marketing side Establishing a successful switch franchise brings a num- ber of factors into play. They include consumer awareness of the Rx product; product performance; order of entry into the OTC market segment; exclusivity within the cat- egory based on some intellectual property, a patent, or Hatch-Waxman exclusivity; launch execution; amount spent to support the launch (consumer advertising and promotion, physician detailing); and brand expansion and innovation through new forms and indications. To understand what can happen when an Rx product is switched into a new OTC category, consider the new 30 July 2015 Tablets & Capsules Figure 1 When the switch from Rx to OTC status is for the first drug product in that therapeutic class—as was the case with Oxytrol—a wide circle of stakeholders beyond the FDA team is required. (Source: US National Library of Medicine) b. OTC version of Oxytrol a. Rx version of Oxytrol The FDA approved the Rx-to-OTC switch of MiraLax in October 2006. Source: National LIbrary of Medicine