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US government shutdown leaves FDA running on empty

Funding row means shutdown could break 21 day record

FDA

The ongoing US government shutdown has left the FDA with just a month of funding left, because it can’t accept any new user fees from industry.

Commissioner Scott Gottlieb gave an update on the agency's finances via a weblink to the JP Morgan Healthcare conference yesterday, which he couldn’t attend in person because the shutdown means that federal staff travel is restricted.

The agency is essentially operating on reserves from user fees received in the last financial year because the shutdown – brought about by an impasse between President Donald Trump and senior Democrats on allocating $5.7bn in funding for the proposed Mexico border wall – means the fees set in the 2019 budget haven’t been approved.

It has a month of funding left for drugs, a two to three months for medical devices and a couple of months for generic drugs, all of which are financed using different user fee programmes.

Gottlieb

Commissioner Gottlieb: FDA will maintain its most critical functions

“We’re starting to take steps to look at how we reduce the burn rate and reallocate resources,” said Gottlieb, who also issued a series of tweets on the plans.

“One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post-market drug safety surveillance,” he said. “We want to make sure that the critical components of the FDA’s consumer protection mission can continue.”

Behind the shutdown, of course, is the impact on the lives of federal workers who often have to continue to work without pay, and the contractors who see their employment summarily suspended or terminated.

Those working in drug regulation are still able to tap into 2018’s user-fee pot, but others reliant on federal funding are not receiving salaries. The first payday since the shutdown began is due on Friday.

Gottlieb said one consequence of this is that any necessary travel – for example to visit and inspect food and drug production facilities – is now being put through a central credit card, so FDA employees don’t have to use their own accounts “given there is some uncertainty about what the duration of this shutdown is going to be.” Routine inspections for things like food safety are also being suspended.

“All of our work at the FDA is critical, so nothing we stand down is unimportant. But the functions that can most directly impact consumer safety will continue, to the best of our abilities, subject to the legal and financial limitations of the current circumstances,” said Gottlieb.

It seems likely that the latest shutdown will linger for a while yet, setting it on course to break the 21-day record set in 1996 when the deadlock was precipitated by an impasse between a Democratic President (Bill Clinton) and a Republican-led House.

The last extended shutdown – centred on President Obama’s Affordable Care Act (ACA) – was in 2013 and lasted 16 days. During that shutdown around 800,000 federal employees were furloughed. The current tally stands at 19 days.

Last week Trump said he was prepared to continue the shutdown for “months or even years” to get his way on funding of the border wall, suggesting one way to force the issue would be to declare a state of national emergency, which would sidestep the need for congressional approval.

Trump is reported to have stormed out of a meeting with senior Democrats Nancy Pelosi and Chuck Schumer on the matter, who have accused him of governing by “temper tantrum.”

Article by
Phil Taylor

10th January 2019

From: Regulatory

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