FDA Details Draft Goals for OTC Monograph User Fee Program

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-10-2017 14:14


The US Food and Drug Administration (FDA) has released draft goals and procedures for a potential user fee program for nonprescription or over-the-counter (OTC) drugs. The program, subject to Congressional authorization, would provide funding to supplement Congressional non-user-fee appropriations and support FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in OTC monographs. The FDA also issued notice of a webinar on August 23, 2017 that will further discuss the proposed program.

The August 23 webinar is intended to be a follow-up to a public meeting on June 10, 2016 and a stakeholder webinar on September 6, 2016 that invited input on the proposed OTC user-fee program. The August 23 webinar will provide an overview of proposed performance goals and procedures related to a potential new OTC monograph user fee program.

The proposed program, if authorized by Congress, would run in fiscal years 2018 to 2022. Goals set by the FDA for the proposed program include hiring 30 new full-time employees by 2018 with an additional 75 by 2022 as well as putting infrastructure into place with improved review timetables and development in leadership, information technology, user-fee collection system implementation, and collection activities.

While new drug applications and abbreviated new drug applications are product-based, in which a single product must be approved by the FDA, by contrast, the monograph system is ingredient-based, according to information from the FDA. This means numerous sponsors may make the same ingredient for the same use and all may market drug products made with this ingredient as long as they comply with all applicable regulations, including the conditions of the monograph.

“The OTC monograph drug review process remains one of the largest and most complex regulatory programs ever undertaken at FDA,” said the agency in offering information on the rationale for a user- fee program. The FDA estimates that there are approximately 88 simultaneous rulemakings in 26 broad therapeutic areas encompassing hundreds of thousands of products and approximately 800 active ingredients for over 1,400 different therapeutic uses. The FDA says it needs additional resources to work toward finalization of the monograph review process and to address safety issues in a more efficient and timely manner. The agency said that additional resources would also better enable the FDA to consider innovations for drug products containing monograph ingredients, such as the development of new dosage forms for ingredients under existing monographs.

Source: FDA (proposed goals) and FDA (August webinar)


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