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Regulatory Focus™ > News Articles > 2019 > 5 > FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

Posted 21 May 2019 | By Michael Mezher 

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.
In 2018, FDA issued a draft guidance, Innovative Approaches for Nonprescription Drug Products, that discusses two alternative approaches that could be used to supplement the information in a DFL. Under the first approach, additional labeling could be used to supplement the information in the DFL, while in the second approach, drugmakers could present additional conditions for consumers to meet to ensure the product can be used safely and effectively.
The additional conditions, Silvis said, could include digital health technologies, such as mobile applications or “in-store digital kiosks” that could be used to screen or evaluate patients before they can purchase a nonprescription product.
Silvis added that FDA is hoping to hear from sponsors that wish to follow those approaches for specific applications and that the agency is “actively working on a proposed rule that will provide more information on this topic.”
Silvis also said that FDA’s Office of New Drugs reorganization will improve its staff’s ability to review applications, including those for OTC products.
“The result [of the reorganization] is that FDA’s subject matter experts will have more time, better analytic tools, and more knowledge management support to advance the clinical and regulatory principles we rely on to evaluate the safety and efficacy of innovative products, including innovative approaches for OTC products,” Silvis said.
Silvis also suggested that the agency’s recently released MyStudies app could potentially be used to gather real world evidence to support the use of nonprescription drugs.


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