In the not so distant past, the U.S. FDA has taken a rather conservative stance concerning Rx-to-OTC switches. Many potential categories have been discounted as not safe and/or effective without a physician’s prescription. This has compelled drug manufacturers to judiciously consider which drugs, if any, they would seek to switch given the necessary multi-million dollar expenditure on prerequisite clinical trials including self-selection, actual-use, and label-comprehension studies with consumers before the application and approval process with the FDA can even begin. With its recent NSURE (Nonprescription Safe Use Regulatory Expansion) initiative, there are encouraging indications that FDA is becoming more receptive to allowing greater Rx-to-OTC switches.
Within the 2010-2012 timeframe, switch activity has been light with only two medications approved, including Merck’s digestive medication Zegerid OTC and Sanofi’s allergy medication, Allegra. Encouragingly, in 2013 there are increasing signs of receptivity from regulators following the FDA issuing a new paradigm initiative NSURE in late 2012, which openly states the agency will consider novel switches, has the intention of protecting novel innovator companies from unfair generic competition, and does not intend to create a BTC class of drugs.
In March 2013 the FDA approved Merck’s Rx-to-OTC switch application for Oxytrol for Women which treats overactive bladder and creates a never-before-marketed OTC category. This new medication in transdermal patch form is expected to be on retail shelves in September 2013.
As recently as July 2013, the FDA’s Nonprescription Drugs Advisory Committee voted 10-6 in favor of the Rx-to-OTC switch of Sanofi’s nasally inhaled corticosteroid for allergic rhinitis, Nasacort AQ. If the FDA ultimately approves this switch it would be the first medication in the nasal allergy steroid class to be sold without a prescription in the U.S. Of further note was the Advisory Committee’s acceptance of two label comprehension studies and one human factors study in support of the switch. Noticeably absent from the studies supporting this switch application are clinical studies such as actual-use or self-selection studies. What will be interesting is whether or not an OTC version of Nasacort AQ will be granted Hatch-Waxman market exclusivity since most drugs that have been granted such market exclusivity had clinical trial studies to support their switch applications.
Other classes that historically have not been considered viable OTC categories may now be considered for Rx-to-OTC switch including: oral contraceptives, cholesterol, erectile dysfunction, benign prostatic hyperplasia, incontinence, migraine, sleeping aids, emergency asthma inhalers, and anaphylaxis medications. These are particularly promising times for switch opportunities and Kline’s timely, comprehensive and authoritative Rx-to-OTC Switch USA: New Paradigm for Growth will allow objective assessment of the Rx-to-OTC switch landscape including analysis of recently approved switches and forecasts of future switches in the United States.