FDA commissioner, Scott Gottleib, released a statement on 7/17/18 discussing new draft guidance related to expanding pathways to OTC drug approval. The new guidance is part of the FDA's efforts to advance a modern framework that is intended to help lower healthcare costs and empower consumers to correctly select drugs that may have previously only been available via prescription.
To help consumers determine if a nonprescription drug is appropriate, Gottlieb discussed several approaches. One option might be a mobile medical app that provides recommendations based on a set of questions answered by the consumer. Another option might new drug labeling that includes information beyond what is already required.
In discussing how non-prescription access might be expanded, Gottlieb said, “We envision this process will work as follows – a sponsor, for example one that has a prescription cholesterol-lowering drug or a prescription naloxone product, could develop one of these innovative approaches to increase the likelihood of correct self-selection and accurate use of their product in the nonprescription setting. After performing appropriate studies demonstrating that the novel approach works as intended, in other words, that consumers can safely use the drug without a prescription and associated supervision of a health care professional, the sponsor could submit an application for FDA consideration for nonprescription status for the product.”
There are currently two regulatory pathways to get drugs approved for OTC marketing: the Over-the-Counter (OTC) Drug Review (OTC Monograph Process) or the New Drug Application (NDA) process. The new draft guidance applies to drugs under the NDA process and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription.
The draft guidance contains two approaches for demonstrating safety and effectiveness where the standard Drug Facts Labeling (DFL) may not be sufficient. The first approach involves the use of additional labeling beyond that currently required. The second approach involves developing additional conditions that help consumers self-select an appropriate medication. Either of these approaches may involve the use of technology.
Gottlieb makes it clear that the new draft guidance does not include a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription. Though the approaches outlined in the guidance could lead to the approval of a wider range of medications being approved for nonprescription marketing.