Rx-to-OTC Switch Pipelines USA

United States Lags Behind Other Nations in Rx-to-OTC Switch Approvals

In contrast to the U.S. FDA, regulatory agencies outside the United States have been much more aggressive in approving switches for conditions outside the typical OTC paradigm. The United Kingdom in particular takes pride in being at the forefront of switching. U.K. Pharmacy Minister Earl Howe has continually stressed that increasing patient choice by making more medicines available without a prescription is a priority for the British government. When speaking at the Proprietary Association of Great Britain conference in London on July 5, 2012, he stated, “The United Kingdom leads the world in the range of products available without a prescription—but more can always be done.” 

The push for greater access to medicines in the United Kingdom started in 2000 when the National Health Service (NHS) outlined its aim to make more medicines available without prescription in order to widen access to medicines and patient choice. The NHS is the publicly funded healthcare system for England. It is the largest and oldest single-payer healthcare system in the world.

In 2000, the NHS tasked the Royal Pharmaceutical Society of Great Britain (RPSGB) to take the lead in identifying potential therapeutic categories suitable for reclassification. At the same time, the Pharmaceutical Industry Competitiveness Task Force (PICTF) agreed the process for reclassifying prescription-only medicines should be streamlined. The new process was intended to make the whole process quicker and easier for pharmaceutical companies and allow them to better plan their switches. Medicines for the treatment of benign prostatic hyperplasia (BPH), male pattern baldness, and cholesterol are also available without a prescription in the United Kingdom.

The United Kingdom is not the only country to be more proactive about switch than the United States. Triptans for the treatment of migraine have switched in numerous countries including the United Kingdom, Germany, Sweden, and New Zealand. Erectile dysfunction medications are also available without a prescription in markets outside the United States. Sildenafil, the active ingredient in Viagra, was approved in October 2014 as a special behind-the-counter product in New Zealand that can be sold without a prescription by pharmacists who have had special training. The pharmacist administers a screening tool that allows only men ages 35-70 without heart disease to purchase the product. The switch initiative was not led by Pfizer, but rather Douglas Pharmaceuticals, which markets this drug in New Zealand under the brand name Silvasta.

Industry research conducted by Kline for its Rx-to-OTC Switch Pipelines USA: Competitive Assessment report suggests that switch receptivity in the United States may be changing. There are a wide variety of categories with switch candidates that may have significant impact on many companies across the OTC and Rx markets. This newly published report provides details on recently approved switches and forecasts of future switches by company in the United States. Included in the forecasts are future switches in existing OTC categories as well as projected switches that would create new OTC categories. The analysis also features access to Kline’s proprietary FutureView Forecasting model with sales forecasts by company.

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