Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access for consumers typically results in increased sales and profitability for pharma and biotech companies. As a further benefit, the FDA may award three-year exclusivity for new OTC products, allowing sponsors to delay competition from generics.

The 2021 sales value of Rx-to-OTC switches was around $35 billion. Future Market Insights predicts this figure will grow at 5.3 percent CAGR, reaching $58 billion by 2031.¹ Given the potential advantages of switching, many sponsors are looking for a way to participate. The question is, which products are suitable?

While the Rx-to-OTC regulatory process is more straightforward, swifter, and less costly than one might expect, it has unique requirements. Intelligent product selection is key to ensuring the best chance of approval. This blog outlines criteria that will help sponsors select their best candidates for moving from prescription to the retail shelf.

Take cues from the relevant FDA regulations

In the United States, the FDA provides clearly defined regulations with specific steps for changing a drug’s status from Rx to OTC. At base, the purpose is to ensure that patients can use the product safely and correctly on their own.

Sponsors will be expected to provide evidence showing that:

The product has generated a comfortable cushion of efficacy and safety data
Consumers are likely to be able to self-diagnose correctly and select the right product
Consumers can follow the instructions correctly to benefit from the treatment without coming to any harm

Evidence may be derived from historical data, new consumer behavioral studies, or additional clinical trials.

Engage in a data-driven risk/benefit analysis

Given that no drug is 100 percent safe, deciding whether to move ahead with an Rx-to-OTC migration requires a case-by-case, data-driven risk/benefit analysis. Points to consider include:

In view of regulators:

What is the drug’s safety profile?
How long has it been on the market?
How much safety data has been collected to date?
Does the data show a wide margin of safe use without professional supervision?
Will consumers be able to self-diagnose the condition the product treats correctly?
Will consumers be able to exclude themselves if appropriate?
Will consumers be able to select the right product?
Are consumers likely to use the drug correctly, according to the instructions provided?
What is the potential for abuse?

In view of consumers:

How much need or desire exists for this product?
How hard is it to use?
How tolerable are the side effects?
Will the product seem worth the OTC cost?

Schedule a pre-meeting with the FDA before finalizing the decision

After the sponsor’s preliminary evaluation, pre-meeting with FDA is essential, as many factors determine the success of an Rx-to-OTC switch development program. Once applicants present their supporting data, the FDA will evaluate each case and suggest exactly what data and studies are needed for an optimal application.

Some products will have been on the market long enough that existing, original pre-market approval safety and efficacy data combined with post-marketing data will suffice. This is the most favorable situation. Alternatively, sponsors may be required to take the time to collect additional safety and efficacy data.

Once convinced of the low potential for harm, the FDA will move on to practical considerations: Can consumers use the prescription product safely and effectively over the counter? The FDA will specify the kinds of consumer studies they feel will best demonstrate whether the product can be packaged and labeled such that consumers will use it appropriately.

While these behavioral studies must be performed correctly, it’s important to note that they are typically much faster and less costly to complete than clinical studies. Therefore, the most suitable candidates are likely to be products that will not require additional clinical studies to satisfy FDA.

Key takeaways

For a successful switch from Rx to OTC, sponsors should choose products with a track record of safety that consumers can use effectively according to OTC product labels. A data-driven risk/benefit analysis and consultation with the FDA will help sponsors decide which products to target for a switch.

The regulatory pathways for moving prescription drugs to OTC are straightforward but specific. Premier provides strategy, design, and implementation expertise and resources for the necessary consumer and clinical studies. Contact us for help with product selection and to streamline your Rx-to-OTC journey.

[1] Rx-to-OTC Switches Market Snapshot [Internet]. Future Market Insights. 2021 [cited 2022 Mar 25]. Available from: https://www.futuremarketinsights.com/reports/rx-to-otc-switches-market