- Impact of the Government Shutdown on FDA
- New ANDA Prioritization Pilot Program
- FDA Holds PreCheck Meeting with Stakeholders
Impact of the Government Shutdown on FDA
On October 1, the federal government “shut down” due to a lapse in appropriations. For FDA, this lapse in funding means that certain activities are halted, including the acceptance of applications for drug and biological products, or medical device submissions that require a user fee payment. However, some activities will continue due to carryover user fee funding and other funding sources. These include certain regulatory activities related to human and animal drugs, biosimilars, and medical devices, such as the review and marketing authorization of new medical products and the review of clinical research requests. Similarly, all activities related to tobacco product regulation will continue. Activities necessary to protecting human life and property, such as emergency response, drug shortage mitigation, outbreak management, safety surveillance, inspections, and enforcement, will also continue during the shutdown.
As we discussed previously, FDA has lost hundreds of employees this year through retirements, resignations, and workforce reductions. Now, with the shutdown, FDA will carry out certain essential functions with an even further reduced staff. According to FDA’s contingency plan, which summarizes halted or continued activities during the shutdown, 13,872 employees (86% of FDA staff) will be retained during this period. We will continue to monitor the shutdown and any important developments affecting FDA.
New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing
On October 3, FDA announced a new “pilot prioritization program” for abbreviated new drug applications (ANDAs). To incentivize investment in U.S. drug manufacturing and testing, the program will offer priority review to generic drug companies with ANDAs meeting the following criteria: (1) either the pivotal bioequivalence testing was conducted in the U.S. or a waiver of bioequivalence testing applies, and (2) the finished dosage form manufacturer and API supplier are both located in the U.S. This initiative follows FDA’s September 30 public meeting, discussed below, on its PreCheck program. FDA notes in the ANDA priority review announcement that stakeholders attending the meeting mentioned “how incentives such as faster reviews could spur additional investment in U.S. manufacturing and research and development.”
FDA Holds PreCheck Meeting With Stakeholders
In a past issue of the Pulse we discussed FDA’s announcement of its PreCheck program, which aims to increase the construction of drug manufacturing facilities in the United States by offering manufacturers increased communication with FDA during key stages, providing early feedback, and holding pre-application meetings to streamline development of an application’s chemistry, manufacturing, and controls (CMC) section. Recently, AgencyIQ reported on the September 30 public meeting FDA held to receive feedback on the proposed program. During the event, pharmaceutical industry stakeholders offered their thoughts on the program’s eligibility criteria and advocated for its expansion. Stakeholders also used the meeting to express their concerns with the current pre-approval inspection framework, particularly timing and coordination. Companies still interested in providing their thoughts on the PreCheck program have until October 30 to provide comments.