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Agnes Shanley is senior editor of Pharmaceutical Technology.
Core functions and those funded by fiscal year 2018 user fees are continuing, and 59% of the agency’s staffers are being retained.
As a result of the ongoing US Congressional impasse over approaches to and funding for US border security, a number of US government agencies officially ran out of funding on Friday, Dec. 21, 2018, with the funding lapse triggering a shutdown on Dec. 22, 2018.
This is the third such shutdown to take place in 2018 and the second this year to affect FDA. The first, which took place in January 2018, was resolved within a few days, and the second, in February 2018, within hours.
At this point, it is not known how long the December 2018 shutdown will remain in force. However, FDA will only be partially affected. The agency is retaining 59% of staffers and furloughing, or temporarily laying off, the remaining 41% until federal funding issues have been settled (1-3).
According to the advocacy group, Alliance for a Stronger FDA, which issued an update (4) on Dec. 21, 2018, furloughs were expected to affect FDA employees who are involved in the development of regulations, and those who focus on administrative and policy-related work. Staff members appointed by the president, as well as members of the agency’s commissioned corps (roughly 1000 staffers in various departments), are among those being retained during the funding lapse period.
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 Dec. 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.
1. FDA, “FDA Lapse in Funding Information,” fda.gov, December 26, 2018.
2. HHS, “
,” hhs.gov, December 21, 2018.
3. HHS, “HHS Contingency Plan Staffing,” hhs.gov, December 21, 2018.
4. Alliance for a Stronger FDA, “What Happens At and After Midnight, Cinderella,” strengthenfda.org, December 21, 2018.
5. R. Prebula, P. Katz, et al., "Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects," lexology.com, December 27, 2018.