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Trump Freezes FDA & Puts 21st Century Cures in Jeopardy

Trump Freezes FDA & Puts 21st Century Cures in Jeopardy | Pharma Industry Regulation |

A federal hiring freeze could put FDA in a vise, squeezed between complying with obligations to implement new programs created by the 21st Century Cures Act and meeting user fee goals for medical product reviews.


The 21st Century Cures Act authorizes $500 million over a decade for FDA to implement the law. Most of the money is allocated to hiring new staff.


A day after President Trump ordered a short-term federal hiring freeze and demanded a long-term plan to downsize the federal government, the effects on FDA are unclear. The agency referred questions to the White House, which hasn't responded to inquiries. Agency officials said privately that they do not know whether and how the freeze will be imposed on FDA. The agency's Center for Drug Evaluation and Research has hundreds of unfilled positions.


The order seems to prevent FDA from exempting positions funded by user fees. It says the freeze "applies to all executive departments and agencies regardless of the sources of their operational and programmatic funding, excepting military personnel."


The freeze does not apply to political appointees.

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