The impact of the FDA shutdown on the pharma industry

16 January 2019

As the US government shutdown enters a record fourth week, FDA Commissioner Scott Gottlieb as stated that the agency is now facing one of the most significant operational challenges in its history. FDA staffers will now be expected to work unpaid to carry out work that is “necessary to identify and respond to threats to safety of human life,” said Gottlieb.

The FDA and other government agencies are caught in the crossfire, and Gottlieb said last week that he had already been forced to reduce or eliminate non-urgent activities to meet to meet the FDA’s consumer protection mandate.

The regulator is now down to its last few weeks’ worth of user fee cash from the previous financial year, which is critical to fund its operations. With no prospect of additional funding before the shutdown ends, it has been forced to furlough more than 40% of its workforce. However the 15 January saw 400 FDA staff return to their posts in an unpaid capacity.

Gottlieb’s list of activities that will have to be undertaken by these employees includes an expansion of inspection activities to include “foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities.”

The excepted activity list also includes “expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices.”

 “Many key functions aren't getting done…but we're focused on maintaining core activities that directly impact consumer safety and save lives,” said Gottlieb. “My priority is to our consumer protection mission and the people executing mission critical functions.”

During the shutdown, the FDA have also stated that no drug approvals can be initiated because funding is required to perform reviews. However, other drugs already in the process of being reviewed are not subject to the same restrictions as this can be funded from fees already received. "We continue to operate the programs using carryover user fees, and we’ll prioritize work that impacts public safety, as this is our foremost priority,” stated Gottlieb.

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