Government shutdown having major effect on FDA

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WASHINGTON — The U.S. Food and Drug Administration has roughly five weeks of funding left to review new drug applications during the shutdown, commissioner Dr. Scott Gottlieb reported this past week on Twitter.

Many experts predict this could have a ripple effect, bogging down the approval and manufacture of new drugs, delaying patients from getting these treatments and adding to a host of other crucial FDA actions and oversight that have taken a hit during the shutdown.

The partial government shutdown began on December 22 after Congress and the White House failed to reach a spending deal. On January 12, it became the longest government shutdown in U.S. history.

In order to keep reviewing applications for the next five weeks, Gottlieb said the agency has stretched its remaining funds, which came from user fees paid by drug companies before the shutdown. The FDA is not allowed to accept new fees or applications until the shutdown is over.

“We’re shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions,” Gottlieb said.

This does not include blood and allergy-related products which are not covered by a user fee program, “so routine review activity ceased related to new products in these categories,” Gottlieb also said. For medical devices, the FDA has about three months on the clock, though “we’re still working through the final numbers,” he added.



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