USA – FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

In a speech at the Consumer Healthcare Products Association’s Regulatory, Scientific and Quality Conference on Tuesday, US Food and Drug Administration (FDA) Chief of Staff Lauren Silvis said the agency is committed to boosting access to safe and effective nonprescription drugs.

In the US, nonprescription drugs can be marketed by conforming to an over-the-counter (OTC) monograph or via the new drug application (NDA) pathway.

“On the monograph side, I want to make clear today that OTC monograph reform remains a top priority for the agency,” Silvis said, noting “it’s up to Congress to legislate on this issue.”

For nonprescription NDA products, Silvis said the agency is “pushing forward” with its nonprescription safe use regulatory expansion (NSURE) effort to promote prescription to nonprescription switches.

Silvis also said the agency is working to address one of the issues drugmakers face when considering a prescription to nonprescription switch, which is how to ensure a drug can be used safely and effectively in a nonprescription setting when a traditional drug facts label (DFL) is not enough to ensure safe use…