Abstract
Abstract
Objectives
This evaluation assesses the quantity, uniqueness, and innovative nature of the past 20 years of Rx-to-OTC (RTO) switches, where a current prescription (Rx) product is reclassified for over-the-counter (OTC) status. Broadening access to more OTC drugs with well-established safety and efficacy could help to reduce healthcare expenditure and address public health challenges.
Methods
The FDA-maintained RTO switch list website was accessed to generate the primary dataset. Each product listed was assessed for the current OTC availability in the United States of its active ingredient, pharmacological class, and indication to determine its innovative quality. Descriptive statistics were employed in this study.
Results
From January 2002 through August 2022 there were 45 RTO switches. Among these, 51.1% involved a new to OTC active ingredient, 22.2% involved a new pharmacological class, 6.6% involved a new indication, and 82.2% were considered follow-on products that introduced a new to OTC active ingredient or new dosage form of an already marketed active ingredient to treat an existing OTC indication. A small minority (6.6%) were considered an exceptional innovation that would offer US consumers a genuinely novel OTC product, providing a new to OTC active pharmaceutical ingredient, pharmacological class, and indication. Overall, there was 1 exceptional innovation every 6.7 years.
Conclusions
Over 40 RTO switches have come to the OTC market in the past 20 years; however, exceptional innovations that expand access to new to OTC active ingredients for new indications are rare. Policies and strategies that result in more innovative switches that can benefit consumers and public health should be evaluated.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference54 articles.
1. U.S. Food and Drug Administration. Prescription-to-Nonprescription (Rx-to-OTC) Switches. https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches.
2. U.S. Food and Drug Administration. Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products. https://www.fda.gov/media/75626/download.
3. U.S. Food and Drug Administration. Guidance for Industry Self-Selection Studies for Nonprescription Drug Products. https://www.fda.gov/media/81141/download.
4. U.S. Food and Drug Administration. Nonprescription Drugs Advisory Committee. https://www.fda.gov/advisory-committees/human-drug-advisory-committees/nonprescription-drugs-advisory-committee.
5. Shiffman S, Sweeney CT. Ten years after the Rx-to-OTC switch of nicotine replacement therapy: what have we learned about the benefits and risks of non-prescription availability? Health Policy. 2008;86(1):17–26.