Each year Americans make nearly 3 billion trips to buy over-the-counter (OTC) products, with the average household spending over $300 annually on OTCs. Despite the huge market for sunscreen, toothpaste, ibuprofen, and the thousands of other products we find on the shelves, until just a few years ago FDA was required to regulate OTCs using an antiquated rulemaking process. This method involved several phases of federal register publications to finalize approved monographs, determining allowable ingredients, indications, dosages, and directions. This onerous decades-old process hindered innovation and created significant delays in approving product changes that improve safety and efficacy. Considering these deficiencies, congress established the OMUFA program in March 2020. OMUFA is modeled after the successful Prescription Drug User Fee Act (PDUFA), establishing industry-paid fees to support FDA’s regulatory activities, while setting performance goals that provide consistency for industry partners.
OMUFA includes six important goals for reforming the OTC Monograph drug review program:
Over the past several years, FDA’s Office of Business Informatics (OBI) has worked closely with key stakeholders across the Center for Drug Evaluation and Research (CDER) to roll out innovative informatics systems needed to successfully execute the OMUFA program. One of these mission-critical system is the OMUFA submission portal, built using CDER’s NextGen Portal platform. The Portal is a cloud-based system that allows industry to submit their OMUFA information through intuitive and accessible interfaces, as well as receive secure responses from FDA. OMUFA is the first of FDA’s user fee programs to exclusively use this modernized system for all submission and communication needs.
Another indispensable component in this ecosystem is CDER Nexus – a workflow management system built using an industry leading low-code development platform. Nexus provides the automation and process standardization needed for FDA to successfully meet its OMUFA commitments as the program continues to grow.
The core systems being used to deliver on the promise of the OMUFA program embody FDA’s vision of scalable, efficient, and secure technology investments. The initial OMUFA program is nearing the end of its 5-year duration, with OMUFA II under negotiation and planned to be passed into law by the fall of 2025. OBI looks forward to the next 5 years of delivering technology solutions that help CDER’s dedicated personnel protect the health and safety of the American public!
