The layoff leaves 58 percent of FDA employees on the job, which Gottlieb said is higher than the previous shutdown in 2013.
The shutdown of the federal government has forced the U.S. Food and Drug Administration to place 42 percent of its employees on furlough, Commissioner Scott Gottlieb announced on Twitter Sunday morning.
For the latest info on @FDA shutdown plans and our efforts to ensure critical activities continue during the lapse in funding, see https://t.co/xfLVvrHN4b pic.twitter.com/eyOvPptQ3X — Scott Gottlieb, M.D. (@SGottliebFDA) January 22, 2018
That leaves 58 percent of FDA employees on the job, which Gottlieb said is higher than the previous shutdown in 2013. In a series of announcements on Twitter, Gottlieb outlined what the FDA will be able to do during the shutdown. He stressed that the agency’s “mission critical surveillance of adverse events for drugs, medical devices and other medical products” will continue. He said the FDA has a team in place to address any issues that may arise during the shutdown. Gottlieb also said the FDA will continue to oversee food recalls and monitor and respond to outbreaks of foodborne illnesses. The FDA will also be able to continue to review some New Drug Applications during the shutdown due to carryover user fees, Gottlieb said.
I’m grateful for efforts of #FDA colleagues who remain on the job during shutdown to perform critical work to protect public; and I’m committed to do what we can to address hardship on those who find themselves on furlough as a result of lapse in funding https://t.co/xfLVvrHN4b pic.twitter.com/xxed4oyuIn — Scott Gottlieb, M.D. (@SGottliebFDA) January 22, 2018
“Ensuring patients have access to novel, beneficial medical products is key part of our work to protect & promote public health,” Gottlieb tweeted.
While the FDA will be able to review some NDAs, companies that hoped to file an NDA will have to wait until the government is fully operational again before they can file. Several drug companies have anticipated filing NDAs this month. It is unknown at this time what the delay will mean for those companies.
Gottlieb also said the FDA and the U.S. Centers for Disease Control will continue to monitor the widespread flu outbreak that has resulted in the death of several patients.
Although the FDA placed nearly half of its employees on furlough, Gottlieb did request that all employees report for duty this morning so they can learn how to “transition their obligations” if they are asked to stay home.
The U.S. government officially shut down over the weekend after Congress could not reach an agreement on a spending plan that would keep the government open. The longest government shutdown lasted 21 days.
The shutdown isn’t only affecting the FDA. The National Institutes of Health has is also facing the same situation and some critical research could grind to a halt, Vox reported. New patients hoping to enter clinical trials conducted by the NIH will not be able to, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases at the NIH, told the Associated Press last week. Fauci was critical of what the stoppage means to scientific experiments.
“You have experiments that have been going on for months if not years, and then all of a sudden you’ve got to stop — you can’t do that,” Fauci told the AP. “You can’t push the pause button on an experiment when you inject an animal with a particular substance to see what the response is and then you have to go home for a week.”
Lawmakers are attempting to resolve the shutdown, but immigration reform is proving to be a sticking point as neither side of the political aisle has yet to give. Another vote is scheduled in the Senate today. If it passes, it would still have to be approved by the U.S. House of Representatives.
