Patient, Physician Groups Call for End to Government Shutdown

Alicia Ault

January 23, 2019

Some 60 patient advocacy organizations and medical professional societies are calling on Congress and the Trump Administration to end the stalemate and reopen the federal government, saying that the shutdown is cutting into the US Food and Drug Administration's (FDA's) ability to ensure that Americans are protected from harm and have access to the latest therapies.

The FDA is one of the few health-related agencies that has been subject to the government shutdown, as its funding is lumped together with that of the Department of Agriculture, even though it is part of the Department of Health and Human Services (HHS). HHS had its 2019 budget approved by Congress last year, so is not affected by the shutdown.

"The ongoing government shutdown forces the FDA to make difficult choices regarding to which essential functions its greatly reduced resources are directed," said the patient and physician groups in their letter to President Donald J. Trump and the majority and minority leaders of the US House and Senate. "These are decisions that never should have to be made — the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients," wrote the signatories, which included the American Society of Clinical Oncology and the American Academy of Pediatrics.

When the shutdown started, about 41% of the 17,397 people employed by the FDA were not working and were not being paid (furloughed). As of January 18 (the latest information available from the agency), 31% were furloughed. Thirty-seven percent of staff were working on activities funded by pharmaceutical and medical device user fees and were being paid, and 9% were unpaid and working on nonuser fee activities. Twenty-three percent were working part time and partially paid.

FDA Commissioner Scott Gottlieb, MD, has been updating the public on the agency's activities periodically via Twitter. Earlier in January, he said that the agency likely only had funding to last through the week of February 11.

Gottlieb also said that some workers would be called back to carry out inspections of high-risk foods and surveillance and inspections of high-risk drug-, medical device-, and pharmacy-compounding products and facilities.

Agency staffers brought back to work are also adding to the list devices monitored for adverse events and malfunction and expanding recall-related activities. Some 260 recalled workers are devoted to inspections of high-risk device-, drug-, and biological-manufacturing facilities, Gottlieb said in a January 15 tweet.

The patient and physician groups said that was not enough. "While we applaud Commissioner Gottlieb, FDA leadership, and 'essential staff' for truly heroic work to keep many aspects of its mission functioning, we fear that this continued shutdown not only puts the current health and safety of Americans at risk, but has begun to put future scientific discovery and innovation in jeopardy," they wrote.

"We ask that the President and Congress act immediately to bring the FDA back to its full capacity. Americans' health and patients' futures are at stake."

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