In a recent publication in the journal Therapeutic Innovation & Regulatory Science, the authors sought to measure the innovative nature of the past 2 decades of RTO switches that have been FDA-approved in the U.S.
In this analysis, the FDA-maintained RTO switch list website was accessed to create a primary dataset. Using descriptive statistics, each product documented was evaluated for the current OTC availability in the U.S. of its active ingredient, pharmacological class, and indication to establish its innovative quality.
The authors wrote, “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 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.”
In this study, authors included definitions for a “new pharmacological class,” a “new indication,” and an “exceptional innovation.” A “new pharmacological class” was defined as a product within a class of drugs that was not formerly accessible to consumers in a marketed OTC product prior to the switch. A “new indication” was defined as a product that established a novel OTC indication that was not previously FDA-approved for consumers. An “exceptional innovation” was defined as one that established a new-to-OTC active pharmaceutical ingredient, pharmacological class, and indication in the same switch of which none were previously available in the OTC marketplace.
The results revealed that there were 45 RTO switches from January 2002 through August 2022. Among these medications, 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.
The authors also indicated, “A small minority (6.6%) were considered an exceptional innovation that would offer U.S. consumers a genuinely novel OTC product, providing a new to OTC active pharmaceutical ingredient, pharmacological class, and indication. Overall, there was one exceptional innovation every 6.7 years.”
The authors noted that examples of “exceptional products” included RTO switches of levonorgestrel for emergency contraception, orlistat for weight loss, and oxybutynin for overactive bladder in women.
The authors noted that accessible OTC treatment choices could help ease burdens on the healthcare system, permitting patients to self-treat, and greater patient and consumer self-sufficiency in healthcare can encourage a more health-conscious and informed population.
Based on their findings, the authors concluded that while there were over 40 RTO switches in the past 2 decades, exceptional innovations that increase access to new to OTC active ingredients for new indications are scarce. The authors also indicated that there is a need for more evaluation of policies and strategies that prevent more switches, and implementation of these policies and practices could result in more innovative switches that can benefit consumers and public health.
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