The FDA’s NSURE Initiative Update: Delving into the Agency’s Continued Exploration of a New Paradigm for “OTC Drugs With Conditions of Safe Use” and Its Potential Impact on the Future of Rx-to-OTC Switches

October 29, 2013 8:15am

Larry Miller
Chief Counsel
Pfizer Consumer Healthcare

Mr. Rikin Mehta PharmD, JD, LLM
Deputy Director
United States Food and Drug Administration

William A. McConagha
Sidley Austin LLP

The FDA’s NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative has been incorrectly perceived by many as an initiative for the creation of a third class of drug product or a behind the counter (BTC) class of drugs. However, NSURE’s goal is instead to bring certain Rx drugs to OTC status with the proviso for ‘conditions of safe use.’ While the Rx-to-OTC switch mechanism has long been used as means to take certain prescription drug products (meeting established criteria) to non-prescription status, the NSURE initiative would take this accepted concept a bit further through the creation of certain monitoring mechanisms which have yet to be set. FDA, together with the Engelberg Center for Health Care Reform at the Brookings Institute and certain OTC industry stakeholders have held several workshops exploring means by which certain products outside the realm of a ‘traditional’ switch candidate can be brought to market.
This session will explore these findings; the future of Rx-to-OTC switches; the use of technology; and physician and pharmacist assistance in the furtherance of NSURE’s goals. Points of discussion will include:
NSURE update
• Summary of findings of NSURE’s focus groups
• How NSURE’s goals coincide with the greater goals of health care reform in the U.S. – cost savings, preventative care, and efficiencies
– remedy for under treatment of disease and certain chronic conditions
– comparison of NSURE’s objectives with international OTC paradigms
• Examining FDA’s authority, goal, objectives and strategy to approve and monitor OTC drugs with ‘conditions of safe use’
• Defining conditions of ‘safe use’
• Ensuring safe use
– label comprehension studies
– self-selection
– actual use tests
• Use of pharmacists and physicians in the NSURE initiative
– is the use of such a learned intermediary counterintuitive to the OTC concept?
– does the product under such circumstances become something akin to the European category of behind the counter product?
• Utilization of new technologies to ensure conditions of safe use
– can technology replace the learned intermediary?
– would use of certain technologies remove the OTC product status from that of a drug to that of an OTC device of combination product?
Evolution of Rx-to-OTC Switch in light of NSURE Initiative
• Understanding how the NSURE Initiative may determine the future course of Rx products eligible for an OTC switch
• How NSURE may alter the basic tenants of OTC eligibility, i.e.,
self-diagnosis and self care
• Exploring switches in the last year which are indicative of the evolution of OTC classification and switch eligibility
– Oxytrol
– Plan B
• How the NSURE initiative may influence filings of citizen petitions and other third party challenges to force switches of Rx products which have been traditionally outside of the OTC sphere