Day 19 of the Shutdown: FDA Shifts User Fee Funds to Postmarket Surveillance

Regulatory NewsRegulatory News | 09 January 2019 |  By 

With a compromise over the border funds nowhere in sight, the US Food and Drug Administration (FDA) is now shuffling funds around to try to better surveil pharmaceuticals rather than to work on drug applications.

The shift comes as more than 7,000 FDA staff, or 41% of the agency, have been furloughed because of the shutdown, while the remaining 10,344 have been retained, although those numbers may shift if FDA runs out of prescription drug user fee money, which is possible if the shutdown continues for another month or so.

Gottlieb also explained yesterday in a keynote at the JP Morgan biotech conference that the medical device user fee funds have two to three months left, while the generic drug user fee funds has about one month left before running dry.

FDA Commissioner Scott Gottlieb tweeted on Tuesday evening: “We’re making decisions across our portfolio to focus FDA resources to key consumer protection functions. 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.”

And there may be more shifts coming with regard to how user fee funding is allocated.

“We’re systematically reviewing our portfolio and making sure that our safety functions remain resourced as best they can, for as long as they can. Our consumer protection role is our most critical mission… 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,” Gottlieb said.

He also further clarified that the agency’s process for reviewing imported medical devices has not been hurt by the shutdown.

“During the shutdown, FDA continues its work reviewing medical devices imported into the US to determine the potential risk to human health. We currently are not experiencing any delays in our entry review process,” he said.

As far as what’s been put on hold (in addition to premarket reviews), Gottlieb pointed to unfunded recruitment efforts.

“All our staff is critical. We look forward to bringing additional new scientific and professional staff into FDA once funding is restored,” he said.


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