RE:RE:RE:FDA vs Government Shutdown According to a formal statement (1), FDA is continuing functions that it considers critical to public health, such as emergency inspections, high-risk drug and food recalls, criminal and civil investigations and enforcement, and the screening of imported food and drugs. The agency is also continuing to perform work that was funded by fiscal year 2018 user fees, including the review and approval of new therapies funded by these carryover user fee balances. "User fee funds will allow us to continue to review and approve some types of drug and other medicinal product applications, including filings for medical devices, generic drugs, biosimilars and animal drugs, during the lapse in appropriations," noted FDA commissioner Scott Gottlieb on Twitter.
During the first week of the shutdown, Gottlieb also tweeted statements and posted photographs of FDA staff members performing these activities during the shutdown, including sympathetic and encouraging words to those affected by furloughs and those who have been working during scheduled holidays.
While work on its fiscal year 2018 applications will continue, the Agency will not be able to accept fiscal year 2019 user fees until 2019 funding appropriations have been settled. As a result, FDA cannot accept new drug applications and other submissions that require a fiscal year 2019 fee payment and are submitted during the funding lapse period.
As legal experts from the firm Hogan Lovells wrote on the blog, Lexology.com on December 27, 2018 (5), “Depending on how long the shutdown lasts, [FDA’s] medical product centers may well be looking at a sizable backlog of applications to triage when the agency is fully operational again...Thus, if the current shutdown persists, industry should anticipate that certain agency delays will likely continue for some time.” They also noted that it was still unclear how the furlough period would affect the scheduling of US and offshore facility inspections in 2019.