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32 July 2015 Tablets & Capsules drug products that treat various chronic conditions. By incorporating technology to create "conditions of safe use," NSURE seeks to expand the Rx-to-OTC switch par- adigm. While the Agency has indicated that it is open to novel ideas in switch applications, it does not intend to introduce a third class of drug products, namely behind- the-counter drugs, a system that is used in many other countries. Rather, NSURE is intended to facilitate the development of technologies that improve the consumer's ability to self-recognize the medical condition to be treated and appropriately self- select/de-select before using a new OTC medicine. It is expected that initiatives like NSURE will encourage companies to develop mobile-device apps, sensor technol- ogy, and/or other rapid diagnostic testing-monitoring technologies; smart kiosks offer another avenue to inte- grate HCP knowledge into decision-making before a consumer is allowed to purchase an OTC treatment for an asymptomatic condition or use an OTC medication for an extended period. Expectations Although the easy switches may have essentially been done, there is significant societal need and pressure to give consumers access to more OTC treatments by developing new OTC categories and switching more Rx drugs to OTC status. The switch space promises to be busy, creative, and competitive. Various new technologies could facilitate switches and ensure "conditions of safe use," and the FDA is poised to support new initiatives and technologies. But consumer safety will remain the Agency's ultimate requirement for companies to obtain regulatory approval of new Rx-to- OTC switches. Rx-to-OTC switches will continue to be a demand- ing—but also promising and lucrative—business target. To succeed, manufacturers must be willing to invest in and empower experienced teams to run the switch pro- grams. Finally, for even the most innovative Rx-to-OTC switch to succeed, it must include continuous product and packaging innovation that drives brand growth and consumer engagement. T&C References 1. OTC-specific guidances issued by the FDA. http://www.fda.gov/Drugs/GuidanceComplianceRegulato ryInformation/Guidances/ucm065013.htm. Accessed June 9, 2015. 2. Importance of self-care. Consumer Healthcare Products Association. www.chpa.org/OTCvalue.aspx. Accessed June 15, 2015. 3. Nicholas Hall's DB6 Global OTC Database, 2015. www.db6.nicholashall.com. Accessed June 8, 2015. 4. Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access, Engelberg Center for Healthcare Reform at Brookings, November 4, 2013 5. Statistics on OTC use. Consumer Healthcare Products Association. www.chpa.org/MarketStats.aspx. Accessed June 15, 2015. 6. Lauder SP. Successfully Making the Rx-to-OTC Switch. PM 360, Sept. 18, 2013. 7. Baker DE. Non prescrip - tion Drug Safe Use Regula - tory Expansion, Hosp Pharm, 2013; 48: 448-450. 8. Rx-to-OTC switch. Consumer Healthcare Products Association. www.chpa.org/ Switch.aspx. Accessed June 15, 2015. 9. Rx to OTC Switch Conference. April 29-30, 2015, in Philadelphia, PA. 10. Nonprescription Drug Safe Use Regulatory Expansion (NSURE), Rikin S. Mehta, FDA, October 4, 2012. Acknowledgments The authors thank Nils Ahlgren, R&D director of GI product design at Pfizer Consumer Healthcare, for his contributions to this article and Nicholas Hall & Company for providing US OTC industry and brand sales data. Helmut H. Albrecht, MD, MS, and FFPM, is principal at H2A Associates, 3350 SW 27th Ave, Suite 2203, Miami, FL 33133. Tel. 973 454 9859. E-mail: Helmut@h2a-associates.com. His consulting firm is devoted to innovation and product devel- opment strategy, technology, and opportunity assessments, including claims support for OTC and Rx products. He pre- viously served as senior vice president for R&D at Adams Res- piratory Therapeutics and as vice president in US and global leadership roles in R&D at Novartis Consumer Health. Dr. Albrecht serves as the Industry Liaison Representative on the FDA's Gastrointestinal Drugs Advisory Committee. He is also an adjunct faculty associate professor in the Department of Cel- lular Biology & Pharmacology, Herbert Wertheim College of Medicine, at Florida International University, Miami. Bob Nissen is president of Nissen Consulting Group, 65 Derby Court, Madison, NJ 07940. Tel. 908 419 9254. E-mail: bob- nissen@gmail.com. He has 30 years' marketing and business development experience in the OTC drug industry and held senior positions in the OTC divisions of Abbott Labs, Scher- ing-Plough, and Novartis. He has worked on numerous Rx- to-OTC switches before and after launch, including Afrin, Coricidin, Lotrimin, and Lamisil. He began consulting in busi- ness development and new technology search in 2006. There is significant societal need— and pressure—to give consumers access to more OTC treatments.