The FDA is set to furlough 42% of its staff and significantly cut back its activities in response to the government shutdown. Drugmakers cannot file regulatory submissions that require the payment of a fee until politicians pass a bill to fund the federal government.
FDA commissioner Scott Gottlieb, M.D. took to Twitter to clarify what the agency can and cannot do now that politicians in the Senate have voted against a bill to extend funding. The law permits the FDA to continue performing critical public health activities—such as adverse event surveillance—and access carryover user fee funds so it can review and approve some submissions.
Other activities will be harder hit. The extent to which the shutdown will affect the FDA is illustrated by the fact the agency expects to put 42% of its staff on temporary leave. That is a few percentage points less than during the 2013 shutdown as a larger slice of the FDA’s budget now comes from user fees. But it still represents a considerable loss of capacity for the agency.
Gottlieb has asked employees to report to work on Monday morning to receive information on their status and how to transfer their obligations in the event they are among the 42% of furloughed staff.
The shutdown also places specific restrictions on the FDA’s activities. Notably, the agency is unable to accept regulatory submissions that are supported by fees while the lapse period is ongoing. If the stalemate in Washington, D.C., continues and the lapse period therefore drags on, that could affect the plans of multiple drugmakers. The longest government shutdown lasted 21 days.
There are reasons to think this shutdown will be shorter. The record 1995-1996 shutdown spanned Christmas and New Year’s Day at a time when there was a Democratic president and a Republican-controlled Congress. This time around, a Republican is in the White House and the party controls both chambers of Congress, suggesting that it should take less time to clear the impasse.
By Nick Paul Taylor
Source: Fierce Biotech
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