Recently, in Europe and Japan there have been increased Rx-to-OTC switch approvals and an environment fostering switch. The OTC men’s health category is growing in Europe, with the switch approval of Recordati’s Fortacin (lidocaine 7.5mg/prilocaine 2.5 mg) spray for premature ejaculation, via the centralized switch procedure through the European Medicines Agency. This drug marks the fifth medicine approved for switch through this centralized regulatory body, and it is expected to be launched throughout the EU on a nonprescription basis by early 2021.
This approval follows another one in the men’s health category, in 2019, when Norway approved nonprescription access to Pfizer’s Viagra, an erectile dysfunction medication. Viagra contains sildenafil and is available without a prescription in the United Kingdom, New Zealand, and Poland. Norway had made a concerted effort to change its laws in 2018, to increase the number of drugs available without a prescription, and it created a third class called “non-prescription medicines with guidance.” This classification is one where pharmacists play a key role in guiding consumers and mitigating risks to ensure that more complex medications are used properly. In the case of Viagra, the pharmacist must go through a seven-point checklist of questions with the consumer. If the answer to any of those questions is “Yes,” the pharmacist is not allowed to sell the drug.
In August 2020, Japan’s executive branch, including now-former Prime Minister Shinzō Abe, had asked the Ministry of Health, Labor, and Welfare to establish a division that would promote self-medication and switch; to appoint a more diverse committee to review switch applications, including medical doctors; and to promote more use of in-vitro diagnostics and OTC medicines. The committee that reviews switch applications in Japan has historically blocked several switches from being approved. There are some medications that are not available in Japan without a prescription, but that have been used safely for many years in the United States and Europe. Examples include the omeprazole proton pump inhibitor and levonorgestrel emergency contraceptive. Neither are available in Japan without a doctor’s prescription. With a new, more diverse committee reviewing switch applications, hopefully the number of medications that Japanese consumers have direct access will increase soon.
In places like Canada, the United Kingdom, Japan, New Zealand, and Australia, where a third drug class exists, sometimes called “pharmacy-only” or “behind-the-counter” (BTC), there is potential for innovative switches, where pharmacists can play an important role in guiding patients and ensuring safe medication use. However, in the United States, because of the Food, Drug, and Cosmetics Act, drugs are either OTC or prescription, and there is no formal BTC drug class. In fact, in 2015, the United States FDA denied a citizen’s petition to create a third class of drugs relating to increased availability of Viagra for erectile dysfunction, Chantix for smoking cessation, Lipitor for cholesterol reduction, and Narcan for counteracting narcotic overdoses.
This petition was made by Frederick Mayer, President of Pharmacists Planning Services, Inc., and was denied by Janet Woodcock, the Center for Drug Evaluation and Research Director, on the basis that the FDA would, for example, need studies or other scientific evidence showing that the drug is safe and effective for use “without supervision of a licensed healthcare practitioner or under the supervision of a pharmacist.” While Woodcock agreed that increased access to these medications could be beneficial for consumers, essentially there just was not enough scientific data in the petition to create a formal third class. However, if a switch sponsor, which presumably has vast clinical studies pertinent to safe and effective use of the drug, is able to integrate digital media or other tools that can help consumers determine if a medication is appropriate, effective, and safe for them to use, there could be increased switch activity in the United States as well.
In fact, there are several drugs that are considered switch candidates in the United States, in categories such as oral contraceptives, erectile dysfunction, topical analgesics, smoking cessation, and sleeping aids. Kline’s Rx-to-OTC Switch Forecasts study provides extensive research into each class and offers a comprehensive, objective assessment of the switch landscape. This includes forecasts of switches in the United States in existing OTC categories and projections for new OTC categories. The study provides a broad assessment of “switchable” OTC categories, a specific analysis and forecasts for the most-likely switch categories and drugs, and an analysis of regulatory and retail paradigm shifts and implications for future switches. In addition to a detailed written report, this service provides Kline’s interactive and proprietary FutureView Forecasting Model, to help users predict sales of new switches. For more details, contact us.