Sen­ate com­mit­tee ad­vances FDA user fee bill with ac­cel­er­at­ed ap­proval re­forms

The Sen­ate health com­mit­tee on Tues­day ad­vanced its ver­sion of the FDA user fee reau­tho­riza­tion bill, which like its House-passed com­pan­ion, in­cludes new re­forms to the agency’s ac­cel­er­at­ed ap­proval path­way.

By a vote of 13-9, most­ly along par­ty lines, the com­mit­tee ad­vanced its Food and Drug Ad­min­is­tra­tion Safe­ty and Land­mark Ad­vance­ments Act (FDASLA) to the full Sen­ate for a vote that will like­ly oc­cur be­fore the end of Sep­tem­ber when the cur­rent user fee leg­is­la­tion ex­pires. If the user fee leg­is­la­tion isn’t reau­tho­rized by that dead­line, the FDA will have to start lay­ing off staff.

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