January 15, 2019

Shutdown, Day 25: FDA to restart high-risk food inspections with unpaid workers

Daily Briefing

    FDA Commissioner Scott Gottlieb on Monday announced that the agency is bringing back about 150 furloughed workers to restart inspections of some high-risk food producers in the United States, such as those that produce cheeses, vegetables, and infant formula.

    The workers will not be paid, as the partial government shutdown affecting FDA continues with no end in sight.

    Cheat sheet: Understand the health impacts of the government shutdown

    About the shutdown

    The shutdown occurred after members of the 115th Congress and President Trump failed to reach an agreement on a short-term spending bill to extend funding for seven federal departments, FDA, and other federal agencies, including the Indian Health Service, by the Dec. 22, 2018, deadline.

    Trump last month said he would not sign a short-term spending bill that did not include funding for a wall along the U.S.-Mexico border.

    Trump last week met with leaders of the recently sworn-in 116th Congress to negotiate a plan to fund the federal government and end the partial shutdown, but they did not reach such a deal. Trump during the meeting said he would end the partial shutdown if federal lawmakers agreed to fund the border wall, but House Speaker Nancy Pelosi (D-Calif.) said she would not support such funding, even if it meant the partial shutdown would end.

    Since convening Jan. 3, the Democratic-controlled House has passed two stop-gap measures to fund the remaining departments and agencies, but neither bill included funding for the border wall. The House last week also approved a bill (HR 265) to fund the Department of Agriculture, which includes funding for FDA and would end the partial shutdown at the agency, but the bill has stalled in the Senate. Senate Majority Leader Mitch McConnell (R-Ky.) has said the Senate will not consider any spending bills that Trump will not sign, meaning Democrats likely must first reach an agreement with Trump on border wall funding.

    The House this week will consider two more bills intended to reopen federal departments and agencies affected by the shutdown. Both are continuing resolutions that would provide stop-gap funding for affected departments and agencies. One of the measures, which the House is expected to consider on Tuesday, would provide such funding through Feb. 1, and the other, which the House is expected to consider Thursday, would provide stop-gap funding through Feb. 28.

    House Appropriations Committee Chair Nita Lowey (D-N.Y.) said the measures "offer … Trump and Senate Republicans additional options to end the shutdown while allowing time for negotiation on border security and immigration policy."

    However, Trump has indicated that he will not sign short-term spending measures because he wants a long-term solution.

    FDA to restart high-risk food inspections

    Since the shutdown began, FDA has furloughed about 41% of its workforce and has suspended various services, including its routine inspections of U.S. food processing facilities and its acceptance of applications for new brand-name, biologic, or generic drugs. FDA's core emergency response functions, high-risk recall activities, and some of the agency's user-fee funded work—including most of its drug approval and oversight functions—are still operating.

    Most FDA functions affected by the shutdown pertain to the agency's food safety operations. FDA has furloughed hundreds of inspectors, and the agency has suspended routine inspections of domestic food-processing facilities.

    However, Gottlieb on Monday said the agency is bringing back about 150 inspectors to resume FDA's inspections of high-risk facilities, including those that have a history of issues and those that handle sensitive foods, such as seafood, soft cheese, and vegetables. The inspectors will not be paid during the shutdown.

    Gottlieb also said the agency has redistributed some of its current funding to extend its ability to review current applications for brand-name, biologic, and generic drugs. Gottlieb said he expects the agency will be able to continue such reviews for about another five weeks. However, STAT News reports that some new drugs could be stalled if the shutdown persists and FDA no longer has the funding needed to continue drug application reviews (Choi, Associated Press, 1/14; McPherson, Roll Call, 1/14; Wagner, "PowerPost," Washington Post, 1/14; Birnbaum, The Hill, 1/14; Baker, "Vitals," Axios, 1/15; Florko/Swetlitz, STAT News, 1/14).

    New cheat sheet: The health impacts of the government shutdown

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    Since 1981, when then-Attorney General Benjamin Civiletti decided that a failure to pass new funding bills should result in a cessation of government functioning, there have been 14 complete or partial government shutdowns. Health care has been deeply embroiled in the debates causing them. Indeed, the longest recent shutdown, which lasted 16 days in 2013, was the result of a contentious dispute over the Affordable Care Act.

    While providers generally shouldn’t expect major changes in their day-to-day operations due to a lapse in government funding, they should be aware of the significant indirect implications on the health care system.

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