House passes FDA user fee reauthorization bill

The U.S. House of Representatives on Wednesday passed a bill to reauthorize the Food and Drug Administration's user fee program, reports Regulatory Focus.

The legislation seeks to reauthorize the user fee program through 2022, which allows the FDA to collect fees from drug or devicemakers for new product applications. The agency uses these funds to hire more staff and accelerate the approval process. The FDA will collect about $9 billion in fees between 2018 and 2022, according to Congressional Budget Office estimates.

The bill will now be sent to the Senate for a vote, although a date for the action has not been scheduled yet.

The user fee program must be renewed every five years. As the current program expires at the end of September, lawmakers must approve the final bill before the August recess. If President Donald Trump does not sign the bill by August 1, the FDA will have to layoff about 5,000 employees, according to the report.

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