OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Capitol House

Total annual user fees of $22m to $34m from OTC manufacturers – primarily from facility registrations – are among the proposals in a discussion document circulated by Sens. Johnny Isakson, R-GA, and Bob Casey, D-PA.

Fees would also be raised when companies request changes via the monograph system. While the proposal does not detail the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legislation

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By 

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

Utah Delegation’s Support For Supplement Industry Key For Caucus Restart In Congress

 

Dietary Supplement Caucus e-launched the 119th Congress with Utah Republican House member Mike Kennedy and Texas Democrat member Marc Veasey as co-chairs and with a total of nine senators and 20 House members spanning both parties.

Price To Resolve US Hemp Dilemma Too High In House Appropriators’ FY 2026 FDA Spending Bill

 

Provisions in bill approved by Agriculture, Rural Development, FDA and Related Agencies Subcommittee aren’t likely to pass largely because they set a price too high for delta-8 THC and other ingredients to meet the definition of hemp as a de-scheduled substance.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

More from Policy & Regulation