https://www.forbes.com/sites/joshuacohen/2019/01/10/partial-government-shutdowns-impact-on-fda-drug-approvals/#79925adb2d08Partial Government Shutdown's Impact On FDA Drug Approvals
As the partial federal government shutdown drags on into its third week,
its impact is being felt at many federal agencies, including the Food
and Drug Administration (FDA). In late December, the FDA furloughed
approximately 40% of its employees. The media has focused much of its
attention on the fact that routine food inspections are not being
carried out. The message conveyed by the media is that food safety
across the nation may be at risk. The FDA is hoping to bring back about
150 furloughed employees to conduct inspections of high-risk
food-processing facilities. This is uncertain, however, because for the
duration of the shutdown the returning employees would have to work
without pay.
Besides the impact on food inspection, there are also short-term and possibly longer-term implications for drug development. While the
FDA is continuing to carry out reviews funded by fiscal year (FY) 2018
Prescription Drug User Fee Act user fees, including the review and
approval of new drugs and biologics funded by carryover user fee
balances, the agency is not accepting FY 2019 user fees
until funding appropriations have been authorized, i.e., the political
impasse has been resolved. Consequently, the FDA has suspended reviews
of existing Investigational New Drug (IND) and Biologics License
Application (BLA) applications not covered by user fees, and is not
reviewing applications for new drugs and biologics submitted during the
shutdown period, except for emergency INDs and BLAs. The FDA is also not
reviewing medical device applications submitted during the lapse
period. And, the FDA is curtailing work on regulatory guidance documents
pertaining to medical devices, drugs, and biologics.
Furthermore, until legislation making FY 2019 funding appropriations for FDA is enacted, the agency will not be able to accept
abbreviated new drug applications for generic drugs as well as 351(k)
applications for biosimilars. Moreover, the FDA has stated that funding
to review a number of pending drug and biologic applications will run
out by early February. As a result, the agency is having to shift resources from
pre-market drug review to post-marketing safety surveillance during the
government shutdown. As part of this effort, it is re-allocating
carryover user fees from a number of pre-market drug reviews to
post-marketing drug safety surveillance.
Joshua P. Cohen
