To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill reauthorizes the FDA user fee programs for animal drugs and generic animal drugs for fiscal years 2024 through 2028. It continues the system where pharmaceutical companies pay fees to the FDA to fund the review of their animal drug applications, in exchange for predictable review timelines. The bill also increases revenue targets and adds new fee categories.
Who Benefits and How
The FDA Center for Veterinary Medicine benefits by receiving approximately $58.5 million annually in dedicated user fee funding ($33.5 million for brand-name animal drugs plus $25 million for generics) to hire staff and expedite drug reviews. Veterinarians and pet owners indirectly benefit from faster approval of new animal medications. Companies developing drugs for minor species (like zoo animals or less common livestock) receive fee waivers. Companies using genomically altered animals for drug production are exempted from certain duplicate fees.
Who Bears the Burden and How
Animal pharmaceutical manufacturers face increased costs through higher user fees, with brand-name drug fees totaling $33.5 million annually and generic drug fees increasing from $18.3 million to $25 million. Generic drug companies now face a new $50,000 fee to establish investigational drug files. The FDA itself faces increased compliance burden through new detailed reporting requirements on staffing, costs, and antimicrobial resistance activities.
Key Provisions
- Sets annual user fee revenue target at $33.5 million for brand-name animal drugs (FY2024-2028)
- Increases generic animal drug user fee target from $18.3 million to $25 million annually
- Creates new $50,000 fee for establishing generic investigational new animal drug files
- Adds exemption for genomic alteration applications already subject to other FDA user fees
- Requires FDA report on antimicrobial resistance activities by December 31, 2023
- Mandates enhanced transparency reporting on FDA staffing, costs, and review timelines
- Authorizes mutual recognition agreements with EU and UK for pharmaceutical manufacturing inspections
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Reauthorizes the FDA user fee programs for animal drugs and generic animal drugs for fiscal years 2024 through 2028, establishing fee structures, revenue targets, and reporting requirements.
Who Benefits
- FDA (receives dedicated funding for animal drug review)
- Animal pharmaceutical manufacturers (predictable review timelines)
- Generic animal drug manufacturers (streamlined approval process)
Who Bears Costs
- Animal drug sponsors and manufacturers (pay user fees)
- Generic animal drug companies (new ,000 investigational file fees)
- Companies with multiple products (annual product fees)
Key Policy Areas
Pharmaceutical Regulation, Animal Health, FDA Oversight, User Fees
Primary Purpose
Reauthorizes the FDA user fee programs for animal drugs and generic animal drugs for fiscal years 2024 through 2028, establishing fee structures, revenue targets, and reporting requirements.
Policy Domains
Legislative Strategy
"Continue user fee funding model for FDA animal drug review programs while adjusting revenue targets, fee structures, and adding new fee categories for generic investigational files"
Identified Gains
- FDA (receives dedicated funding for animal drug review)
- Animal pharmaceutical manufacturers (predictable review timelines)
- Generic animal drug manufacturers (streamlined approval process)
- Veterinarians and pet owners (faster access to approved animal drugs)
Identified Costs
- Animal drug sponsors and manufacturers (pay user fees)
- Generic animal drug companies (new ,000 investigational file fees)
- Companies with multiple products (annual product fees)
Sponsors
Greg Pence
R-IN | Primary Sponsor
Legislative Progress
IntroducedMr. Pence (for himself and Ms. Schrier) introduced the following …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Animal drug sponsors and manufacturers, Animal drug sponsors with pending applications from 2018-2023, Animal pharmaceutical industry
Positive-direction: Animal drug sponsors with pending applications from 2018-2023, Animal pharmaceutical industry, Generic animal drug sponsors with pending applications from 2018-2023, Minor use/minor species drug manufacturers
Negative-direction: Animal drug sponsors and manufacturers, Companies with generic investigational files established before October 2023, Generic animal drug sponsors and manufacturers
Congress (House Energy and Commerce, Senate HELP committees), FDA Center for Veterinary Medicine
FDA Center for Veterinary Medicine faces effects in multiple directions
Companies developing genomically altered animals for drug production
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
- "the_secretary"
- → Secretary of Health and Human Services
- "the_secretary"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
Includes activities necessary for implementation of US-EU and US-UK Mutual Recognition Agreements for Pharmaceutical Good Manufacturing Practice Inspections with respect to animal drug products
A request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug
The submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology