Senators To Trump Administration: 'Way Too Late' To Change US FDA Budget Structure Now

Senate HELP Committee leaders Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., said it's "way too late" for Congress to alter the budgetary balance between device and drug industry US FDA user-fee contributions and congressional appropriations for the upcoming 2018-2022 user-fee cycle in tersely worded statements to HHS Secretary Tom Price May 16.

Both Chairman Lamar Alexander, R-Tenn., and Ranking Member Patty Murray, D-Wash., of the Senate Health, Education, Labor, and Pensions Committee flatly turned down HHS Secretary Tom Price's May 15 request to "recalibrate how the FDA finances its medical product review work," by making the device and drug industry foot the bill for 100% of the agency's premarket medical product reviews.

While such an "interesting proposal" might be considered the next time the FDA negotiates the user fee agreements with makers of drugs and devices, Sen. Alexander replied, "it...

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