Given that many of the most obvious “switchable” drugs and categories have already taken place, opportunities that remain in moving medicines from prescription to nonprescription status require extensive research and novel approaches in order to gain FDA approval and be used by consumers safely and effectively without a prescription. There are several opportunities for new product launches in this vain however, the roadmap to get to market remains unclear for novel switches with many unanswered questions. Pharmaceutical companies struggle with the risks of hefty spending on clinical and consumer research to support a switch with unsure outcomes and concerns about the timing of private-label competition if approval is granted.
To ease some of these uncertainties, the U.S. FDA has recently held meetings and collected information from various sources about a new paradigm in switch. The agency has recently drafted a guidance for industry on novel switches called NSURE or Nonprescription Safe Use Regulatory Extension. Some of the major issues addressed and/or raised in the NSURE document include:
- Types of research needed to support novel switches
- Human factors research
- Consumer behavior studies
- Role of pharmacists
- Combined applications tying drugs with diagnostic tools or other consumer health devices
- Use of interactive technology to help consumers make appropriate purchase decisions
- Increased reliance on post-marketing surveillance of switch drugs and less on up-front pre-approval studies
- Authority of FDA to hold private-label makers to the same standards as the innovator companies
- Market exclusivity for novel switches
- Definitively states NSURE is not a third class of drugs
Switch activity has been relatively low over the past few years, and the last time a brand new OTC category was created through switch was with Alli by GlaxoSmithKline being approved back in 2007. However, Merck has brought a whole new drug and category to the OTC market with approval of the Rx-to-OTC switch of Oxytrol for Women overactive bladder treatment in January 2013. This first-in-class switch has not only proven that product labeling will effectively communicate to patients about appropriate use of the product, but Merck will also use a large-scale multimedia urinary health education campaign to inform women about their options for treating OAB, not only by taking Oxytrol, but also about exercises and lifestyle modifications that can be used. Despite concerns among members of an Advisory Committee, that voted 6-5 in favor of the Oxytrol switch, FDA was willing to approve the novel switch and use means beyond product labeling to help support safe nonprescription use. This signals a departure from past FDA decisions and could be seen as a positive step towards making novel switches that benefit consumers as well as pharmaceutical innovators, a reality. We are embarking on exciting times for switches with a whole new breed of medications poised for nonprescription access, once industry and regulators can agree on the best way to get to a win-win scenario, that is.