FDA Chief of Staff Lauren Silvis indicated the FDA is “pushing forward” with its nonprescription safe use regulatory expansion (NSURE) program, and that “OTC monograph reform remains a top priority for the agency” but “it’s up to Congress to legislate the issue.”
In the United States, nonprescription drugs, also called over-the-counter (OTC) drugs, have two ways of making it to market. The first is by way of a new drug application (NDA) pathway. The other is via conforming to an over-the-counter monograph.
The U.S.Food and Drug Administration (FDA)’s Chief of Staff Lauren Silvis gave a speech at the Consumer Healthcare Products Association’s Regulatory, Scientific and Quality Conference yesterday. In it, she said, “On the monograph side, I want to make clear today that OTC monograph reform remains a top priority for the agency.” She added, “It’s up to Congress to legislate on this issue.”
On the NDA pathway, Silvis indicated the FDA is “pushing forward” with its nonprescription safe use regulatory expansion (NSURE) program. In particular, the agency is working to develop approaches to ensure the safety and effectiveness of drugs when they shift from prescription to nonprescription.
The agency issued draft guidance, Innovative Approaches for Nonprescription Drug Products, in 2018. It proposed two approaches, developing labeling in addition to the drug facts labeling (DFL), and implementing additional conditions to guide consumers on appropriate selection and use of the OTC product.
As the agency moves forward on this issue, it is considering including digital health technologies like mobile applications or “in-store digital kiosks” that could potentially screen or evaluate patients before they are allowed to buy certain OTC medicines.
Silvis said that the agency hopes sponsor companies interested in these approaches for specific applications will contact the FDA. She said the agency is “actively working on a proposed rule that will provide more information on this topic.”
In October 2018, Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research (CDER) announced that the FDA was reorganizing the Office of New Drugs (OND), particularly the premarket safety review process and then the investigational new drug (IND) application process.
Silvis noted that this reorganization would improve the OND’s ability to review applications, including the OTC product applications. “The result [of the reorganization] is that the 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.”
Earlier this year, in January, former FDA Commissioner Scott Gottlieb laid out the agency’s new framework for dealing with real-world evidence or real-world date (RWD). These relate to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial.
RWD and RWE are collected from electronic health records (EHR), laboratory tests, wearable devices, insurance claims and potentially even social media. At the time, Gottlieb reassured his listeners at the Bipartisan Policy Center that this wasn’t an indictment of the randomized controlled clinical trial.
“It’s a recognition that new approaches and technologies can help expand the sources of evidence that we can use to make more reliable treatment decisions. And it’s a recognition that this evidence base can continue to build and improve through the therapeutic life of an FDA approved drug or medical device.”
Silvis touched on this topic, suggesting that the FDA’s recently released MyStudies app might be used to collect RWE to support the use of OTC medicines.
