A partial United States (US) Government shutdown has hindered the Food and Drug Administration’s (FDA’s) ability to accept and review regulatory submissions. A notice from the FDA on Government funding lapses, which started in December 2018, states that currently the FDA has no legal authority to collect user fees assessed for their 2019 fiscal year, which prevents the FDA from accepting new regulatory submissions such as 510(k)s and Premarket Applications (PMA) that require fees until Congress and the White House restore full funding. If you are planning to submit applications for US market authorisation in early 2019, you should factor these operational delays at FDA into your commercialisation plans.
Due to the lack of financial funding, approximately 40 percent of FDA employees are not working right now, which means that lots of the operations they oversee are not being addressed. Out of the 400 staff who have agreed to return to work without pay, roughly 100 will deal with high-risk medical device manufacturing facilities, about 70 are focused on inspections of high-risk drug manufacturing facilities and around 90 will inspect high-risk biologic manufacturing sites.
Although the FDA cannot currently accept new medical device registration applications, the agency will continue to carry out oversight functions regarding high-risk medical devices, imported product screenings and novel therapies. The FDA will pursue civil and criminal legal actions related to devices that threaten public health, and carry out surveillance of devices for major safety issues.
According to the notice, the FDA may use carryover fee balances from 2018 to support commercialisation of novel medical devices and technologies. However that holdover funding is expected to run out in February, and no submissions that require 2019 fiscal year user fees will be accepted until full government funding is re-established. This means that several medicines could be left hanging in the balance come the end of February if the Government is still shutdown.
If the US government shutdown continues, the lack of funding will further delay approval of new medicines and could create a backlog of reviews that would affect medicines due for an approval decision later this year. The delay in the potential approval of new medications, will not only impact patients who are waiting for the new medicines, but also the companies who may see changes in investor confidence.
The development and issuance of new FDA guidance documents for medicines, biologics and medical devices has also been affected, as these reviews will now be delayed.