The FDA has made clear that it is interested in hearing your thoughts on the OTC drugs approved through the NDA process and wants your feedback on a number of topics. In a pre-publication notice in the Federal Register yesterday (here), the FDA noted that it would like interested parties to “share their perspectives with FDA on how to increase access to nonprescription drugs.” The information collected is to be used to inform a public meeting on this topic.
The Agency notes, “If the drug does not meet the criteria for prescription-only dispensing, it may be marketed as nonprescription. There are two regulatory pathways to bring a nonprescription drug product to market in the United States.” One is through the OTC Monograph system and the other is through the review and approval of an NDA. “This request for information is focused on the new drug application (NDA) process under section 505 of the FD&C Act.”
“Specifically, FDA is interested in perspectives on the scientific, regulatory, and practical considerations that shape nonprescription drug access. The collected input will help inform topics for a public meeting planned for calendar year 2026.” The Agency has listed several questions that it is seeking input on in order to address the topic, which it says “may improve our understanding and advance our public health mission.”
The Agency has some suggestions on how to address the questions so please see the FR notice cited above for more information. The questions FDA would like to be addressed are:
General:
1. What are challenges faced in the development of drugs for nonprescription use?
2. What are the biggest opportunities to improve access to nonprescription drugs?
3. How could interested parties—including, but not limited to, drug developers, healthcare providers, patients, consumers, and retailers—work together to increase access to safe and effective nonprescription drugs?
4. Looking ahead to a 2026 public meeting, what specific topics or questions would you like to see on the agenda for public discussion?
Scientific Considerations:
5. What scientific barriers most limit progress in increasing access to nonprescription drugs?
6. What additional scientific tools, technologies, or data sources could support access to nonprescription drugs?
7. Are there specific diseases or conditions that have not, traditionally, been treated with nonprescription drugs for which nonprescription drugs could be safely and effectively used without the supervision of a licensed healthcare practitioner? If so, what information would support such use under the applicable statutory and regulatory requirements for nonprescription drugs?
The FDA has been seeking to make more drug products available over-the-counter when appropriate: when the intervention of a healthcare provider might not be needed; when there is sufficient evidence that patients can effectively and accurately self-diagnose the condition; and when adequate labeling can be developed to aid the patient in correctly selecting and taking the medication. Could this meeting impact a move towards more Rx-to-OTC switch applications or more direct-to-market OTC NDA products? Let’s see where this one goes!
