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Health Agencies’ Covid Work to Persist in Event of Shutdown

Sept. 28, 2021, 5:16 PM

Federal health agencies would continue their work combating the Covid-19 pandemic in the event of a government shutdown—even one where the Health and Human Services Department would be forced to furlough 43% of its staff.

The FDA would continue to authorize vaccines, therapeutics, and diagnostics; the CDC’s labs and its 24/7 emergency operations center would stay open; and the NIH would sustain its support for priority Covid-19 research and development, according to an HHS contingency plan.

The Biden administration will “will take every step it legally can to mitigate the impacts of a potential shutdown on our pandemic response, and direct public health efforts would generally proceed under the HHS plan,” an administration official told Bloomberg Law.

Thursday is the deadline to fund the federal government and avert a shutdown. It comes as Covid-19 continues to rage across the U.S., killing more than 2,000 people daily and forcing hospitals in pandemic hotspots to consider rationing care. Meanwhile, federal agencies are working feverishly to increase the nation’s lagging vaccination rate, approve booster shots, and ensure a steady supply of Covid-related drugs and testing supplies.

Avoiding a shutdown likely will require both the House and Senate passing a short-term spending bill.

The House passed a spending bill earlier this month that was opposed by most Republicans because it included a provision extending the government’s debt limit. Republican leaders have said their members will support a government funding measure without the debt limit provision.

The measure would need to be signed into law by 11:59 p.m. ET Thursday to avoid a lapse in appropriations and a shutdown.

“Shutdowns are incredibly costly, disruptive, and damaging. Direct public health efforts can generally proceed during a shutdown because they’re exempt, and that is certainly our intention,” White House Press Secretary Jen Psaki told reporters.

‘The Last Thing We Need’

The HHS would be able to keep a higher percentage of staff compared with 2018, when the last shutdown happened. In 2018, the department furloughed about half its staff—40,845 employees. This year it would furlough about 43%, or about 36,536 people. The HHS has about 3,000 more employees than it did three years ago.

But the department furloughing almost half of its staff is “the last thing we need as we continue to confront the pandemic,” the administration official said.

The main work on the pandemic response comes from the Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health, and some operating divisions within the Office of the Secretary.

Agencies with public safety functions, like the FDA, must evaluate each activity they conduct to determine if it has a source of funding or falls into an exception for “emergency circumstances” that would allow it to continue that work during a shutdown, Stacy Cline Amin, who until January was the agency’s chief counsel and now co-leads the FDA practice at Morrison & Foerster LLP, said.

Although there is a public health emergency declaration for the pandemic, it doesn’t mean the “emergency circumstances” exception during a shutdown applies to all public health work, Amin said. Agencies must evaluate each nonfunded activity to determine if stopping it would “imminently threaten human life or the protection property,” she said.

The public health agencies could make the case that all their Covid-19 work falls into this emergency exception, but that is not the only work they do. The FDA also issues product recalls, inspects manufacturing facilities, monitors compliance with federal laws, and performs other policy work, for example.

Supplemental funding from Covid-19 bills previously passed by Congress can be used to allow some of the work to continue. Buying vaccines, distributing therapeutics like monoclonal antibodies, and clinical trials around Covid-19 would be maintained, according to the contingency plan.

The FDA can use that funding to authorize vaccines, therapeutics, and diagnostics; address and track shortages of drugs or medical products; and stop counterfeit, fraudulent, and misbranded products, the plan said.

And the CDC would continue the work of its 24/7 emergency operations center and maintain the work of its labs, among other pandemic-related activities. The NIH would sustain its support for priority Covid-19 research and development, even as 75% of its staff is furloughed.

“It leaves us with a coat hanger for a public health system,” said Ellie Dehoney, vice president of policy and advocacy for Research!America. “And that is particularly not OK in a pandemic, when there’s a new variant that’s been rumored to be potentially worrisome. We’re still dealing with delta. It’s just not OK.”

‘Already Crushing Workload’

The Office of the Assistant Secretary for Preparedness and Response would keep staff who respond to hurricanes, flu, and other emergencies and disasters. They would include emergency management staff and personnel who manage contracts for the Biomedical Advanced Research and Development Authority—part of the HHS that finances new technologies, drugs, and devices that can be used during a public health emergency or biohazard attack.

The White House has yet to publish its shutdown plan, so it is unclear if the pandemic work from Covid-19 Coordinator Jeff Zients’ team would continue in the event of a lapse in funding.

Amin, who served as FDA chief counsel during the longest shutdown in government history, said the agency receives hundreds of questions about whether activities fall into the emergency exception each day during a lapse in funding.

“FDA is under an almost indescribable level of stress responding to the COVID-19 pandemic as is. I can’t imagine adding the chaos of a government shutdown on top of that already crushing workload,” Amin said.

—With assistance from Alex Ruoff

To contact the reporters on this story: Shira Stein in Washington at sstein@bloomberglaw.com; Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editor responsible for this story: Brent Bierman at bbierman@bloomberglaw.com

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