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US FDA caught in government shutdown turmoil, again


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US FDA caught in government shutdown turmoil, again

The U.S. Food and Drug Administration was caught in the federal government shutdown — a partial closure whose timeline is uncertain, though negotiations between Republicans and Democrats remained ongoing to try to broker a deal to end it.

President Donald Trump's demand for $5 billion to fund a wall between the U.S. and the Mexico border was at the heart of the disagreement.

In an early morning Dec. 21 tweet, Trump warned the shutdown would "last for a very long time."

The White House Office of Management and Budget notified affected federal agencies a few hours before midnight to implement their shutdown plans, saying "Congress has not taken action to pass an acceptable bill."

Shortly thereafter, FDA Commissioner Scott Gottlieb notified his staff in an email and posted a series of tweets saying his agency would proceed with "orderly shutdown operations," though he noted it would not happen until Dec. 26, after the U.S. Christmas holiday.

Federal offices already were planned to be closed Dec. 24 and 25 and most agencies are closed over the weekend.

"I'm truly sorry to have to report this news to our dedicated staff," Gottlieb wrote on Twitter.

The shutdown affects a little more than 7,000 FDA employees, who will be prohibited from coming to work during the closure, though the agency will have thousands of other staff members on hand to handle critical issues.

Sen. Ben Cardin, D-Md., whose state is home to the FDA, said, "There is no such thing as a good shutdown."

All shutdowns — even the short ones — cost taxpayers money, Cardin said on the Senate floor on Dec. 21, a few hours before the midnight deadline, when funding ran out for one-fourth of the federal government, including the FDA.

Cardin's Maryland colleague, Sen. Chris Van Hollen, also a Democrat, expressed concern about the added stress and "unfair burden" the shutdown was causing FDA and other federal employees — many of whom are the senator's constituents.

The two Maryland lawmakers persuaded their Senate colleagues to support a provision that would guarantee back pay for federal workers affected by the shutdown.

The House, however, has not yet passed it. Lawmakers from both chambers were scheduled to reconvene at noon Dec. 22.

Some Republican lawmakers, however, told reporters late Dec. 21 a deal was not yet in sight.

A partial shutdown

Three-fourths of the federal government was funded for fiscal 2019 in earlier spending bills, including 60% of the Department of Health and Human Services, whose agencies include the U.S. National Institutes of Health, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.

Even though FDA is part of HHS, its funding is funneled through appropriations to the U.S. Department of Agriculture, which is part of the 25% of the federal government that has yet to be funded.

Republicans were unsuccessful on Dec. 21 in striking a deal with Democrats before the midnight deadline, even after Vice President Mike Pence, acting White House Chief of Staff Mick Mulvaney and Trump's son-in-law and senior adviser Jared Kushner made a trip to Capitol Hill to urge an agreement.

Senate Republicans mustered enough votes — with Pence breaking a 47-47 tie — on a procedural measure late Dec. 21 to advance a short-term spending bill that included $5.7 billion for Trump's border wall, which the House had adopted the night before.

But Democrats objected and Republican Sens. Jeff Flake of Arizona and Bob Corker of Tennessee — two retiring lawmakers — said they were unwilling to back the House version with the $5.7 billion and would not vote again until an agreement had been finalized between their party members, Democrats and the White House.

Earlier in the week, the Senate had cleared a different version of the short-term spending bill without the $5.7 billion border wall funding. A group of House Republicans, led by Rep. Mark Meadows of North Carolina, balked at that measure and urged Trump to reject it, creating the uncertainty on Capitol Hill.

FDA chief braces staff for shutdown

FDA's Gottlieb warned his staff in a Dec. 20 memo to be prepared for a possible partial shutdown.

The FDA and other federal agencies had gone through a three-day shutdown in January in an earlier dispute between Trump and Capitol Hill, also over the proposed border wall. Another late-night shutdown in early February lasted only a few hours.

Trump had threatened for months he would again shut down the government, declaring last week from the Oval Office he would be "proud" to do so and said he would take the responsibility for it. Later, however, he blamed the Democrats.

The salaries for almost 33,000 HHS employees come from appropriations through the Departments of Agriculture and Interior. About half of those employees work at the FDA, while about 15,300 are employed at the Indian Health Service, though 95% of those staff are being retained under HHS' shutdown contingency plan.

At the FDA, just over 10,300 employees, or about 59% of the agency, are staying on the job during the shutdown, while 41% will not be allowed to come to work and will not get paid over the partial closure.

About 7,400 FDA employees working during the shutdown are being paid from carryover funding, including advanced appropriations, while the salaries for 32 staff members are coming from user fees the agency collects from the industries it regulates, according to HHS.

It said the FDA's tobacco program had sufficient user fees to continue all of its program work.

User fees also support FDA approval of new medical products and the agency's ability to review requests to conduct clinical research, issue guidance and other "necessary activities to help patients have access" to new medicines and lower-cost versions of those products, HHS said.

But an FDA spokeswoman was unable to say how long the user fees the agency has on hand could carry it through a shutdown.

Under the shutdown, the FDA may continue activities it considers vital, like responding to emergencies, managing high-risk product recalls, pursuing criminal enforcement work and civil investigations related to imminent threats to human health or life, reviewing import entries to determine potential risks to health and responding to other critical public health issues, HHS said.

The FDA may also continue to address existing critical public health challenges, including drug shortages and outbreaks related to foodborne illnesses and infectious diseases.

But the FDA is prohibited under the shutdown from supporting some routine regulatory and compliance activities, including some involving medical products, animal drugs and most food-related activities.

The agency's routine establishment inspections, cosmetics and nutrition work and many ongoing research activities also are on hold until the shutdown ends, HHS said.