Increase the base outsourcing facility user fee to a level set by HHS to support timely and regular inspections.
I will increase the base outsourcing facility user fee to a level set by HHS to support timely and regular FDA inspections.
Occurrences
Evidence
Section 5 amends 21 U.S.C. 379j-62(c)(1)(A)(i) by striking "$15,000" and inserting "a base amount deemed appropriate by the Secretary to fund activities to ensure the safety of compounded drug products." Section 4 also requires pre-compounding inspections and at least biennial reinspections for large-scale outsourcing facilities.
The Senate office’s legislation page still lists S.3794 with the latest action as "Read twice and referred to the Committee on Health, Education, Labor, and Pensions."
Assessments
Banks materially advanced legislation that would raise the outsourcing facility user fee to an HHS-set level and support regular FDA inspections, matching the promised mechanism. However, the bill has only been introduced and referred to committee, with no evidence that the fee increase was enacted or implemented. Because this was a serious legislative attempt but did not deliver the promised policy outcome, the correct rating is never with an effort badge.