Introduction
With the support of patients, regulators, and payers, pharma and biotech companies’ interest in converting prescription drugs (Rx) to over-the-counter (OTC) is growing. In 2021, the sales value of Rx-to-OTC switches was around $35 billion USD. According to Future Market Insights, it is expected to rise at 5.3 percent compound annual growth rate (CAGR), reaching $58 billion USD by 2031.
In the United States, the conversion process is highly regulated and has numerous specific steps. However, the overall goal makes perfect sense when evaluated with a case-by-case, benefit-risk analysis:
- Ensuring that the drug has generated a comfortable cushion of efficacy and safety data to date
- Showing that patients are highly likely to be able to self-diagnose correctly and select the right product
- Testing to see whether they can follow the instructions correctly to benefit from the treatment without coming to any harm
The Food and Drug Administration (FDA) requirements are very specific, and not every contract research organization (CRO) has the knowledge to design and perform the appropriate studies. However, given the right expertise, Rx-to-OTC conversions are easier to achieve with less time and expense than one might expect for a regulatory exercise. This white paper de-complicates the process by outlining how we approach these unique studies, the steps involved, and considerations for quickly and efficiently achieving a successful Rx-to-OTC conversion.