There have been signs recently indicating that the environment is becoming ripe for more Rx-to-OTC switches. Since we last reported on this topic in August 2013, we saw the approval of two additional first-in-class switches in categories that would have been thought of as challenging five years ago. One is the first incontinence medication available for sale without a prescription, Merck’s Oxytrol for Women, and the other is the first nasal allergy steroid, Sanofi’s Nasacort Allergy 24HR.
NSURE, combined with the approvals of Oxytrol for Women (Merck) in January 2013 and Nasacort Allergy 24HR (Sanofi) in July 2013, illustrates tangible evidence that the FDA is in fact becoming more and more open to new switches, thereby increasing consumer access to various classes of medications. This paradigm shift is one that the Consumer Healthcare Products Association (CHPA) continues to have on its agenda for 2014 to work with the FDA to move forward along with modernizing the OTC monograph system. With the FDA and CHPA working toward finding ways to make more switches come to market, it is an attractive time for the pharmaceutical industry to creatively expand horizons in this area. Recently there was a very conservative approach to switches among regulators and companies that were hesitant to spend large sums of money on trials and switch applications, which were more likely to be denied than approved.
At a meeting sponsored by American Conference Institute on OTC drugs in New York City on October 29, 2013, the technical lead for FDA’s NSURE initiative, Riken Mehta, spoke and encouraged firms interested in pursuing innovative Rx-to-OTC switches to start a dialogue with FDA now, rather than waiting for the agency to further develop its new paradigm for expanding the availability of nonprescription drugs. Mehta further noted that FDA reviewers are open to discussing what can be done to facilitate switches under the current switch paradigm on a product-by-product basis. In addition, OTC drug manufacturers do not have to wait for the paradigm to mature to suggest a role for new technology or healthcare providers in an Rx-to-OTC switch.
This sort of approach and openness at the FDA is unprecedented, meaning now is the time for the industry to pursue innovative switches and take advantage of the opportunity while the agency’s mindset fosters and nurtures new switch applications. As a result of this increasingly more favorable regulatory environment for the Rx-to-OTC switch, Kline expects a period of robust switch activity in the United States over the next five years with several all new OTC categories emerging along with many new brands entering the market into existing categories. Private-label copies of these new switch brands will also serve to expand the size of the market.
In order to help our clients make informed decisions in these exciting times, Kline has just published the 10th edition in its long-standing series of in-depth reports on Rx-to-OTC switch. Rx-to-OTC Switch USA: New Paradigm for Growth provides subscribers with a comprehensive, objective assessment of the Rx-to-OTC switch landscape including analysis of recently approved switches and forecasts of future switches. This analysis provides forecasts of future switches in existing OTC categories and projections for new OTC or BTC categories to 2018. In addition to the written report, subscribers also have access to Kline’s interactive FutureView Forecasting Model where users can see Kline’s assumptions and forecasts or use the tool to create their own forecasts. For more information please contact Laura Mahecha, Industry Manager, Healthcare, at Laura.Mahecha@klinegroup.com.