Congress Reviews User-Fee Program for OTC Drugs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-14-2017 16:49


The Subcommittee on Health of the US House of Representatives’ House Energy & Commerce Committee held a hearing to examine draft legislation for establishing an over-the-counter (OTC) monograph user-fee program at the US Food and Drug Administration (FDA). 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. In August 2017, the FDA released draft goals and procedures for the potential program.

The subcommittee reviewed draft legislation, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017. The legislation is sponsored by representatives Bob Latta (R-OR), Diana DeGette (D-CO), Health Subcommittee Chairman Michael C. Burgess (R-TX), Health Subcommittee Vice Chairman Brett Guthrie (R-KY), and Health Subcommittee Ranking Member Gene Green (D-TX).

Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, showed support for the legislation as she highlighted its similarity with the Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees and use them for the review of  prescription drugs “Following the success of PDUFA, Congress enacted additional user fee agreements, such as those that cover medical devices, generic drugs, and biosimilar drug products, as well as animal drug products and generic animal drug products. …New legislation is needed to allow FDA to establish a similar program for OTC monograph drug products that will help ensure a better resourced and more streamlined, efficient process,” Woodcock said.

Health Subcommittee Chairman Burgess also supported the bipartisan legislation. “This bipartisan proposal establishes the OTC Monograph User Fee Program and makes a number of meaningful modifications to the monograph process,” stated Chairman Burgess. “The goal is to create a system that is more flexible and more efficient, and reflects the scientific innovations so that patients and consumers have greater access to better and safer OTC drug products.”

House Energy and Commerce Committee Chairman Greg Walden (R-OR) spoke to the need for the creation of the new user-fee legislation. “…the regulatory process in place at FDA has not been updated since the 1970s. As a result, there has been little to no innovation in this sector, and safety-related changes often take years to implement. That is simply unacceptable. Fortunately, FDA, regulated industry, and patient and consumer groups all agree that significant reform is necessary,” Walden said.

The proposed program by the FDA 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.

Source: US House of Representatives' Energy & Commerce Committee



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