‘Skinny’ User-Fee Reauthorization Would Leave Out Diagnostics Reform
A stripped-down version of the US FDA user-fee reauthorization package may be the best Congress can do before the August recess, but some say it won’t be enough.
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A measure that would have moved diagnostics regulation under the US Food and Drug Administration has been culled from the year-end omnibus spending package.
AdvaMed’s Scott Whitaker and Michael Minogue outlined the trade group’s legislative goals for the rest of the year, chief among them regulatory oversight for lab-developed tests.
Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs including MDUFA. Policy riders stripped from the legislation, including for FDA oversight of lab-developed tests, could still find their way into a final FY 2023 spending omnibus.