Generally, a prescription drug becomes a candidate for over-the-counter availability if it is used for a non-chronic condition that is relatively easy to self diagnose and has low potential for harm from abuse. The Food and Drug Administration (FDA) considers three main factors when assessing switch applications: ability of patients to properly self diagnose without professional guidance, benefit-risk ratio, and consumer-friendly labeling. The benefit-risk ratio assessment focuses on whether patients are deemed capable of achieving the intended outcome in a safe manner. A consumer-friendly label implies that the label’s verbiage describes benefits, risks, and dosing in layperson’s terms that are easily understood. For a 30-year period from the mid 1970s to mid 2000s prescription to over-the-counter (Rx-to-OTC) switches were commonplace, from pain, allergy, and heartburn relief, to skincare and smoking cessation products. In spite of periodic enthusiasm expressed by policymakers for more switches – as a way to “empower” consumers - the numbers of Rx-to-OTC switches have dwindled in recent years. But, in the last 10 years there have only been 16 switches, eight of which took place in the allergy/cold space, three were acid reducers, one a contraceptive, one an acne product, one a treatment for red eye, one a drug for overactive bladder, and one a nasal corticosteroid. The latter two drugs represented the only two new therapeutic categories for switches in the last 10 years. Currently, there are two prescription naloxone products; an auto-injector product for self-injection, and a nasal spray formulation, both of which could go OTC. A limited number of suppliers have kept prices relatively high. With respect to naloxone, the FDA is identifying ways to assist manufacturers in submitting an application to the FDA for an OTC version of the product. Specifically, the agency is helping to develop an appropriate package label. The model label FDA is proposing intends to provide consumers with the information they would need to understand how to safely use both formulations of naloxone, including how to use the drug in an emergency opioid overdose situation. The FDA does not initiate switches, though there was one exception in 1982 when it initiated the switch of the asthma drug metaproterenol. Soon after, the switch had to be reversed due to safety concerns. Technically, any entity can submit a petition to FDA to switch a product from Rx to OTC status. However, generally the holder of the approved new drug application - the manufacturer that developed the drug for prescription use – initiates switches. As such, the sponsor needs to drive the switch process, including the design of consumer labeling comprehension studies in coordination with the FDA. Nevertheless, in a few instances states can allow for certain pharmacies to offer a number of products, such as insulin, influenza vaccine, and naloxone, without a prescription. So-called “standing orders or collaborative practice agreements” permit a pharmacy to dispense these products OTC. Forty-six states currently have naloxone available OTC at certain pharmacies. Note, “behind-the-counter” may be a better way of describing these products’ availability as they cannot be taken by customers from the shelf at the pharmacy. A nation-wide switch authorized by the FDA would likely improve access to naloxone, as all pharmacies would have the OTC product. Furthermore, it has been suggested that OTC availability throughout the country and at all pharmacies could stem the increases in naloxone’s price. Ultimately, however, whether naloxone or other products will be switched in the near future will depend on sponsor readiness and willingness to submit switch applications to FDA. There have been attempts at switches in new therapeutic categories. Most notably, in at least three separate instances of switch applications for cholesterol medications in the past 15 years, the FDA deemed hyperlipidemia a category that is too complicated for patients to self diagnose and properly treat on their own. New therapeutic categories may be on the horizon, including erectile dysfunction, migraine, and opioid overdose antidotes, such as naloxone. Given the state of the opioid crisis in the U.S., naloxone is perhaps the most noteworthy of the possible switches. Indeed, the FDA has been exploring options to improve consumer access to naloxone. Building on the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative the FDA aims to reduce what it considers “under-treatment” of conditions that could be safely treated with prescription products if switched to OTC. Source
