The pharmaceuticals industry continues to experience shifts from prescription medications to over-the-counter (OTC) drugs, with the FDA executing  over a dozen transitions in the last 10 years alone. Rx-to-OTC opens new doors for both the consumer and the brand, with rising demand calling for change. Consumers seek greater accessibility and convenience when purchasing medications, along with lower costs. The U.S. OTC drug market is expected to grow at a CAGR of 4.01% from 2021 to 2026, reaching $42 billion in sales by 2024. From the impacts of COVID-19 to the escalation in private labels and online sales, the push for this transition will persevere.  

Positive Impacts 

As vendors continue to create effective new products, they must seek approval from the FDA in a time-consuming and highly regulated process. To successfully make the switch from Rx to OTC, the product must be safe and effective, with easy-to-understand labeling that does not require direct guidance from a physician. The process may be lengthy, but it can have positive returns for years to come.  

Gaining OTC status provides consumers with more convenient drug alternatives, from allergy medications to nicotine replacements. A Consumer Healthcare Products Association (CHPA) study released in 2017 found that the number of individuals suffering from allergies has increased by nearly 9.7 million since 2010. As a result, the number of these individuals who take OTC medications has risen, along with satisfaction rates. While more consumers purchase OTC medications over prescription, a number of allergy sufferers still visit their healthcare providers. Regardless, those who choose OTC over Rx spend an average of $17.53 less on physician costs than those who chose prescription treatment. In the same vein, a study published in The Laryngoscope found a significant decrease in overall patients suffering from nasal allergies. Conducted over more than 12 years, this study attributes the decrease to the increase in OTC switches. Rx-to-OTC switches expand consumer involvement and access, while leveraging digital innovations to ensure safety and accuracy in use. 

Making The Switch 

Since 2002, the FDA has approved dozens of Rx-to-OTC switches for allergy relief, arthritis, and more. Some switches include antihistamines Claritin, Zyrtec, and Allegra, allergic rhinitis Flonase, and emergency contraceptive Plan B. In 2013, the FDA introduced the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative to spark a new wave of Rx-to-OTC switches, and by 2020, the FDA converted its OTC Monograph process to a user fee focus similar to that of prescription drugs and medical devices. Most recently, the FDA approved the switch of allergic rhinitis relief Astepro to nonprescription.  

Various factors contribute to the Rx-to-OTC transition, with changing consumer desires and increasing digitalization impacting the industry. The switch can provide manufacturers life cycle extension while enabling consumers to take proactive control of their health. This prioritization of health and wellness amongst consumers remains prevalent, as one of the pandemic’s many lasting impacts. Establishing OTC status provides consumers with greater control, accessibility, and convenience, along with lower costs and independence from physicians. Consumers often seek OTC alternatives for gastrointestinal, digestive, and cardiovascular issues, cold and flu relief, and even mental health and dietary supplements. 

Looking Ahead 

A vast number of prescription drugs in the U.S., like those for high cholesterol and IBS, already hold OTC status in other countries. As seen in the latest consumer healthcare industry trends, consumers take increasing control of their health and wellness, accessibility and convenience are becoming necessities. OTC alternatives have immense potential in the online market as well, further enabling DTC strategies. The Rx-to-OTC switch not only provides advantages for consumers, but it has the potential to drive market growth for pharmaceutical brands. Eventually, Rx-to-OTC will reap benefits for the generics industry as well. Getting approval and switching prescription drugs to over-the-counter (OTC) is a strenuous process that requires strategic business operations models, but is well worth the benefit to greater consumer access. Our team at Clarkston is here to help, with expert consultants in the Consumer Healthcare industry prepared to ease the process. 

Contributions from Rachel Ruth