Regulatory Focus™ > News Articles > 2019 > 1 > FDA Adds Unpaid Exceptions as the Shutdown Drags On

Regulatory NewsRegulatory News
Posted 14 January 2019 | By Zachary Brennan 

FDA Adds Unpaid Exceptions as the Shutdown Drags On

2933 As the shutdown continues in its third full week, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took to Twitter on Sunday to reveal additional activities that are considered “excepted, unpaid work” because they are necessary to identify and respond to threats to human safety.

The additional activities, which have been added after careful analysis and in close consultation with senior FDA leaders and public health experts, include:
  • Expanded inspection activities, beyond “for-cause” inspections, to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;
  • Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;
  • Expanded monitoring of and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;
  • Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life.
"We're stretching money and are able to extend our runway. We've basically eliminated overhead charges to CDER and CBER and shifted money that typically supports operations to programs. The entire Office of the Commissioner is excepted, unpaid and not burning user fee dollars," Gottlieb said Monday.

User Fee Funds

The additions come as Gottlieb also projected that although FDA can currently support ongoing medical product review processes with user fee funds, those funds will run out in about five weeks for prescription drugs.

"We've stretched our resources by lowering burn by basically deferring internal operating charges and shifting money to salaries," Gottlieb told Focus.

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

Democrats on the Senate Health, Educational, Labor and Pensions committee sent a letter to Gottlieb on Friday, noting that should the remaining FY 2018 balance for these user fee programs expire, the majority of FDA’s ongoing product review functions will cease to continue, and user fee-funded employees – about half of the agency – would not have funding to continue their work.
“Given that, due to the shutdown, FDA is currently unable to perform essential regulatory and compliance activities, we want to ensure the agency is doing everything it can to fulfill its critical public health mission at this time,” the senators wrote.
By 18 January, the senators sought answers to various questions on the user fee funds and burn rate, as well as, “a detailed overview of the increase in anticipated backlog of applications for new medical products at this time, and for each additional week of the shutdown, including, to the agency’s best estimates, when normal functionality can be expected to resume.”


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found