Growing Momentum Behind Rx-to-OTC Switch

FDA leaders, experts discuss future of Rx-to-OTC switch at CHPA event; New study underscores important role of switch to patients, healthcare system
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Recently, the Consumer Healthcare Products Association (CHPA) hosted its Regulatory, Scientific and Quality (RSQ) Conference. The annual event showcased the increased conversation around prescription-to-nonprescription (Rx-to-OTC) switch among regulators, industry experts, and other stakeholders. It comes on the heels of a new study that points to the healthcare system savings from switch.

OTC medicines provide safe, affordable, accessible healthcare options to consumers who are increasingly taking control of their own health. Several different speakers at RSQ commented on the growing importance of Rx-to-OTC switch from different vantage points — consumer advocates, regulators, researchers, as well as technology, legal, and industry experts — all driving at the same point: the modern consumer needs and demands access to more OTC options.

During various panel discussions, experts discussed the evolution of healthcare, including increased use of digital technologies. During his presentation, John Whyte, M.D., Chief Medical Officer, WebMD discussed the consumerization of healthcare, stating, “We've shifted from providers being in charge, to consumers taking charge, and COVID has super charged this trend.”

The benefits of Rx-to-OTC switch are well known. A new study published in The Laryngoscope titled, Contemporary Incremental Healthcare Costs for Allergic Rhinitis in the United States credits the switch of nasal corticosteroids to OTC status with a significant decrease in patients reporting nasal allergy symptoms — allergic rhinitis (AR) — during healthcare visits as well as a significant decrease in “per-person expenditure associated with an AR diagnosis.” This study follows on more than a decade of other evidence around improved consumer outcomes, satisfaction, reduced costs and health system savings related to using OTC products.

In 2018, the U.S. Food and Drug Administration (FDA) issued a draft guidance Innovative Approaches for Nonprescription Drug Products (NSURE), acknowledging that certain types of medicines only available by prescription today may one day be “switched” to nonprescription OTC use if manufacturers can identify novel ways to help consumers correctly self-select and safely use them. This has the potential to expand consumer choice and access to affordable OTC medicines by using digital technologies or other conditions to assure consumer safe use. However, FDA has not yet issued a proposed rule.

During remarks made at RSQ, Janet Woodcock, M.D., FDA’s Acting Commissioner, stated, “Our goal remains the development of a pathway that's appropriately flexible to apply to existing FDA approved prescription drugs as well as new drugs that would seek FDA approval as nonprescription with their initial approval. Regarding the timing of such a change, I can assure you the agency is very focused on advancing this effort with the intention of issuing proposed rulemaking in the near future.”

In addition to Dr. Woodcock’s and Dr. Whyte’s keynote remarks during the opening general session, the importance of innovation in the OTC space was acknowledged by FDA and other speakers throughout several of the topical breakout sessions during the two-day virtual event, including:

  • Considerations for the Future of Rx-to-OTC Switches. At this session the panel discussed how changes in healthcare will influence future switches, learnings from consumer research, and regulatory perspectives on successfully navigating future switch applications. During the session, Frank Becker, M.D., Acting Director, Division of Nonprescription Drugs II, Office of Nonprescription Drugs, Center for Drug Evaluation and Research, noted that NSURE was a priority for FDA and that the proposed rule would expand on the concepts in the draft guidance.
  • Innovation Opportunities for Consumer Self-Care. This session focused on the role of technology and other innovative approaches in facilitating novel Rx-to-OTC switches. The panelists discussed how the COVID-19 pandemic changed the way consumers view self-care and engage with the healthcare system and retail settings. The panel explored how these behavioral changes – combined with advancements in healthcare technology – inform the future of Rx-to-OTC switch and consumer behavior research.
  • Closing General Session: FDA and USP Leadership. During this closing session, Theresa Michelle, M.D., Office of Nonprescription Drugs, Center for Drug Evaluation and Research, FDA mentioned that NSURE was one of her office’s top priorities.

Registration is still open for those who wish to view the recorded RSQ sessions mentioned above as well as on-demand content. The content is available until October 10.

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.