The US House of Representatives voted to pass legislation reauthorizing several user fee programs at the US Food and Drug Administration (FDA) on June 8, 2022. Nonetheless, writes BioWorld, there are several substantive differences between H.R. 7667 and the parallel US Senate bill—differences that may take some doing to overcome before a final bill can be forwarded to the president.
In discussing these differences, partner Jackie Berman told BioWorld that the Senate bill is relatively short on pharmaceutical provisions compared to the House bill. The two bills address some of the same areas, albeit a little differently when there is overlap.
The House bill’s pilot program for unannounced drug facility inspections is “interestingly not in the Senate bill,” Jackie said, adding that the Senate bill is directed more toward broad oversight of FDA drug facility inspection issues, as seen in Section 902. She said the Senate’s approach is striking, given the agency’s experiences with inspections over the course of the COVID-19 pandemic.
Jackie also noted that the House and Senate bills are fairly aligned regarding accelerated approval drugs, but that the Senate bill gives the FDA more enforcement authority around those approvals.
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