FDA Reports on Accomplishments for First Year of OMUFA

As readers of this blog may recall, in March 2020, as part of the CARES Act, the FDC Act was amended to include statutory provisions that (1) reform and modernize the way over-the-counter (OTC) monograph drug products are regulated in the United States and (2) authorize FDA to assess and collect user fees from manufacturers of OTC monograph drug products and submitters of OTC monograph order requests.  New Section 744N(a) of the FDC Act, requires FDA to report annually on its progress in achieving the goals identified in the Over-the-Counter Monograph Drug User Fee Program (OMUFA) performance goals and procedures document.  On February 22, 2022, FDA issued its first annual OMUFA report covering FDA’s accomplishments during the period of March 27, 2020 (the date of the enactment of the CARES act) through September 30, 2021.

Despite the demands of the pandemic, FDA met many of its first year goals.  FDA

• issued a notice in the Federal Register announcing the availability of certain deemed final orders (DFO), and plans for modifying the regulations to make them consistent with the OTC monograph reform provisions.
• started posting DFOs on FDA’s new web portal called OTC Monographs@FDA.
• posted the first annual forecast for planned monograph activities.
• issued a request for proposals to secure information technology (IT) services in support of mandated technical requirements and awarded a contract to provide such IT services, somewhat ahead of its schedule.

Due to the pandemic hiring of new staff and delays in FDA’s collecting OMUFA fees which are required to fund new staff members, FDA did not reach its goal for hiring and onboarding new staff members.  Instead of the target 30 new staff members, it hired/onboarded only 13 staff members (i.e., 43% of the goal).  It remains to be seen how this delay in hiring will affect FDA’s ability to meet future goals.