Covid work of health agencies will persist in case of shutdown

Federal health agencies would continue their work to fight the Covid-19 pandemic in the event of a government shutdown, even if the Department of Health and Human Services would be forced to put 43% of its staff on leave.

The FDA would continue to authorize vaccines, therapeutics and diagnostics; CDC laboratories and its 24/7 emergency operations center would remain open; and NIH would maintain support for priority Covid-19 research and development, HHS says emergency plan.

The Biden administration “will take whatever steps it can legally take to mitigate the impacts of a potential shutdown on our response to the pandemic, and direct public health efforts would generally occur as part of the HHS plan,” said an administration official at Bloomberg Law.

Thursday is the deadline to fund the federal government and avoid a shutdown. It comes as Covid-19 continues to rage in the United States, killing more than 2,000 people a day and forcing hospitals in pandemic hotspots to consider rationing care. Meanwhile, federal agencies are working feverishly to increase the country’s delayed vaccination rate, approve booster injections and ensure a constant supply of Covid-related drugs and testing supplies.

To avoid a shutdown, the House and Senate will likely have to pass a short-term spending bill.

The House passed a spending bill earlier this month that most Republicans opposed 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 is expected to be enacted by 11:59 p.m. ET Thursday to avoid a credit cutoff and shutdown.

“Shutdowns are incredibly expensive, disruptive and damaging. Direct public health efforts can usually continue during a shutdown because they are 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 to 2018, when the last shutdown occurred. In 2018, the department put about half of its staff on leave, or 40,845 employees. This year it would be leave about 43%, or about 36,536 people. The HHS has about 3,000 more employees than three years ago.

But the department putting nearly half of its staff on leave is “the last thing we need as we continue to deal with the pandemic,” the administration official said.

The main work on the pandemic response comes from the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health and some operational divisions of the secretary’s office.

Agencies with public safety functions, such as the FDA, must assess every activity they conduct to determine whether it has a source of funding or falls under an exception for “emergency circumstances” that would allow it to pursue that activity. working 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, that does not mean that the “emergency circumstances” exception during a shutdown applies to all public health work, said Amin. Agencies must assess each unfunded activity to determine whether its termination “would imminently threaten human life or protective property,” she said.

Public health agencies could argue that all of their Covid-19 work falls under this emergency exception, but it 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.

Additional funding from Covid-19 bills previously passed by Congress can be used to allow some of the work to continue. The purchase of vaccines, the distribution of therapeutic products such as monoclonal antibodies and clinical trials around Covid-19 would be maintained, according to the emergency plan.

The FDA can use this funding to authorize vaccines, therapeutics, and diagnostics; treat and monitor drug or medical product shortages; and stop counterfeit, fraudulent and mislabelled products, according to the plan.

And the CDC would continue the work of its 24/7 emergency operations center and maintain the work of its laboratories, among other pandemic-related activities. The NIH would maintain its support for priority Covid-19 research and development, even though 75% of its staff are on leave.

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

“Already crushing the workload”

The office of the Assistant Secretary for Preparedness and Response would keep staff responding to hurricanes, influenza and other emergencies and disasters. They would include emergency management staff and staff who manage contracts for the Biomedical Advanced Research and Development Authority, which is part of the HHS that funds new technologies, drugs and devices that can be used during a public health emergency or of a biohazardous attack.

The White House has yet to release its closure plan, so it is not clear whether the pandemic work of the team of Covid-19 coordinator Jeff Zients would continue in the event of a lack of funding.

Amin, who served as chief counsel for the FDA during the longest shutdown in government history, said the agency receives hundreds of questions every day about whether the activities fell within the exception of emergency in case of lack of funding.

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

—With help from Alex Ruoff

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