Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb has taken to Twitter to offer updates on how the agency is managing to do its job during the partial government shutdown and showing that some employees are showing up for work despite not knowing whether they will be paid for their time.
“Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can’t collect FY 2019 user fee payments during the shutdown, which means we can’t accept new applications for products under user fee programs,” Gottlieb tweeted Dec. 29, early into the shutdown, which has now crept into the first week of the new year.
Work on drug reviews that is not user fee funded will cease during the shutdown, and the agency’s Center for Biologics Evaluation and Research (CBER) will put on hold any non-emergency work on whole blood, blood components for transfusion, allergenic extracts and human cells, tissues and cellular and tissue-based products (HCT/P), he said.
All over-the-counter monograph drug activities in the FDA’s Center for Drug Evaluation and Research will also be paused with the exception of any emergency work related to these products.
The 30-day review clock for any pending, non-emergency investigational new drug or device (IND) not covered by a user fee program also will be suspended and the clock reinstated when the lapse period is over, Gottlieb tweeted.
But new emergency INDs and IND amendments related to the safety of individuals currently participating in clinical trials will continue to be reviewed during the shutdown whether or not they are covered by a user fee.
Gottlieb was appointed to the helm of the FDA by President Donald Trump, who has dug in his heels about funding for a wall along the southern border of the U.S., which led to the government shutdown.
About 59 percent (or 10,344) FDA employees have been retained during the shutdown, and 41 percent (7,053) have been furloughed, according to the Alliance for a Stronger FDA.