I will increase the base outsourcing facility user fee to a level set by HHS to support timely and regular FDA inspections.

Jim Banks · Indiana · Republican

spending impact 5.00 specificity 1.00 extraction confidence 96%

Commitment kind: unknown. Promised action: not established. Promised outcome: not established. Deadline: unknown; not assumed expired.

Occurrences

Increase the base outsourcing facility user fee to a level set by HHS to support timely and regular inspections.

Banks will increase fees to fund more frequent drug facility inspections by the FDA.

Senator Jim Banks Introduces SAFE Drugs Act to Crack Down on Risky and Fraudulent Weight Loss Drugs
primary · press_release · model gpt-4.1

striking '$15,000' and inserting 'a base amount deemed appropriate by the Secretary to fund activities to ensure the safety of compounded drug products'

The bill would replace the fixed outsourcing facility base fee with an amount set by the Secretary to fund safety-related activities.

BILLS-119s3794is.pdf
primary · other · model gpt-5.4-mini

Evidence

unverified · Source version 16559 · locator unknown

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.

Unverified model/legacy excerpt; not proof. AI summary (separate from source): The introduced bill contains the promised fee increase and ties it to FDA oversight and inspections, but it is still only introduced legislation rather than enacted law.

partial later_term A for effort

S. 3794 Introduced in Senate (IS) - Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026
secondary · model gpt-5.4-mini · confidence 96%

unverified · Source version 769 · locator unknown

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."

Unverified model/legacy excerpt; not proof. AI summary (separate from source): As of the latest official Senate office listing, the bill has not advanced beyond committee referral, so the promise remains unresolved as a policy outcome.

unresolved later_term

Legislation - Senator Jim Banks
primary · model gpt-5.4-mini · confidence 82%

unverified · Source version 61960 · locator unknown

Last Action Date Listed July 27, 2026 Actions Mr. Banks (for himself and Mr. Heinrich) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions, Reported by Mr. Cassidy, with an amendment Bill Number S. 3794 Bill Version Reported in Senate (RS)

Unverified model/legacy excerpt; not proof. AI summary (separate from source): Official GovInfo status shows Banks' S. 3794 was reported in the Senate with an amendment, not enacted or implemented; this confirms continued effort but no delivered policy outcome.

never later_term A for effort

S. 3794 (RS) - Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026 - BILLS-119s3794rs | Content Details | GovInfo
secondary · model gpt-5.5 · confidence 93%

unverified · Source version 61957 · locator unknown

<DELETED>SEC. 5. BASE ESTABLISHMENT FEE.</DELETED> <DELETED> Section 744K(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-62(c)(1)(A)(i)) is amended 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''.</DELETED>

Unverified model/legacy excerpt; not proof. AI summary (separate from source): The reported Senate text strikes the base-establishment-fee provision that would have replaced the $15,000 base with an HHS/Secretary-set amount, so the active version no longer contains the promised fee increase.

never later_term A for effort

S. 3794 Reported in Senate (RS) - Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026
secondary · model gpt-5.5 · confidence 96%

unverified · Source version 73917 · locator unknown

08-04-2026 | S.3794 | SAFE Drugs Act of 2026 Latest Action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.

Unverified model/legacy excerpt; not proof. AI summary (separate from source): Banks' official Senate legislation list shows S. 3794 advanced to the Senate calendar, but does not show enactment or implementation of the promised user-fee change.

never later_term A for effort

Legislation - Senator Jim Banks
primary · model gpt-5.5 · confidence 90%

unverified · Source version 73919 · locator unknown

Under section 744K(c) of the FD&C Act, the amount of the establishment fee for a non-small business is equal to $15,000 multiplied by the inflation adjustment factor for that fiscal year, plus the small business adjustment factor for that fiscal year

Unverified model/legacy excerpt; not proof. AI summary (separate from source): FDA's FY2027 fee notice still applies the existing statutory $15,000-based formula rather than an HHS-set base amount, indicating the promised policy has not been implemented.

never later_term

2026-15342.pdf
secondary · model gpt-5.5 · confidence 94%

unverified · Source version 86282 · locator unknown

524 S. 3794 A bill to amend the July 27, 2026.--Senator Cassidy, Committee on Health, Education, Labor, and Pensions, with an amendment in the nature of a substitute. (No written report.)

Unverified model/legacy excerpt; not proof. AI summary (separate from source): Within the lookback window, the official Senate Calendar still lists S. 3794 only as a General Order reported from committee, not as passed by Congress or enacted; this confirms continued legislative effort but no delivered user-fee change.

unresolved later_term A for effort

Senate Calendars for October 6, 2026 - 119th Congress, 2nd Session-GENERAL ORDERS
secondary · model gpt-5.5 · confidence 93%

verified · Source version 86290 · locator 5957

The annual establishment fee is equal to the sum of $15,000, multiplied by the inflation adjustment factor, plus the small business adjustment factor. The fee calculation is reflected in the following equation: Establishment fee = $15,000 x inflation adjustment factor + small business adjustment factor.

Fetched verbatim passage. AI summary (separate from source): FDA’s current outsourcing facility fee page still describes the statutory $15,000-based formula rather than an HHS-set base amount, indicating the promised fee mechanism has not been implemented.

never later_term

Human Drug Compounding Outsourcing Facility Fees | FDA
secondary · model gpt-5.5 · confidence 94%

verified · Source version 86290 · locator 1892

FY 2027 registration period for outsourcing facilities starts October 1, 2026, and ends December 31, 2026.

Fetched verbatim passage. AI summary (separate from source): During the lookback window, FY2027 outsourcing-facility registration opened under FDA’s existing fee program; there is no sign of a new HHS-set base user fee taking effect.

never later_term

Human Drug Compounding Outsourcing Facility Fees | FDA
secondary · model gpt-5.5 · confidence 90%

Assessments

Public state: unverified As of unknown · legacy_unverified · . Original AI recommendation (not independently established): never. later_term A for effort

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.

provider codex_cli · model gpt-5.5 · confidence 90%