FEDERALhearing transcript

Hearing on Reauthorizing Animal Drug User Fees (ADUFA and AGDUFA)

Original title: REAUTHORIZATION OF ANIMAL DRUG USER FEES: ADUFA AND AGDUFA

January 1, 2018

animal health FDA drug regulation user fees veterinary medicine

Track this bill to get notified when it advances a stage. One tap to stop, anytime.

The Frame

What this does

The reauthorization of these programs determines how the FDA funds the review and approval process for animal medications, which directly impacts the timeline for bringing new veterinary treatments to market.

Who is mentioned in the record

Potentially affected actors named in the source documents. Mention is not a position.

Animal drug manufacturers

These companies pay user fees to the FDA to support the review of their drug applications.

Veterinarians

The availability of new animal drugs depends on the efficiency of the FDA approval process funded by these fees.

FDA Center for Veterinary Medicine

The agency relies on these user fees to fund the staff and resources required to review animal drug applications.

What changed

Last recorded activity January 1, 2018.

What's next

Next step not available in the current record.

Summary

The House Subcommittee on Health held a hearing to discuss the reauthorization of the Animal Drug User Fee Act () and the Animal Generic Drug User Fee Act (). These programs allow the FDA to collect fees from drug companies to fund the review process for new animal drugs.

Why It Matters

Key Facts

The hearing focused on the reauthorization of ADUFA and AGDUFA, which are set to expire.
ADUFA and AGDUFA allow the FDA to collect user fees from animal drug manufacturers to support the drug approval process.
The subcommittee reviewed a discussion draft of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018.
The hearing included testimony from FDA officials, the Animal Health Institute, the Generic Animal Drug Alliance, and the American Veterinary Medical Association.
The goal of these programs is to ensure the FDA has the resources necessary to conduct timely reviews of animal drug applications.

Frequently Asked Questions

What are ADUFA and AGDUFA?

These are federal programs that allow the FDA to collect fees from animal drug companies to help pay for the costs of reviewing and approving new animal drugs.

Why does the government need to reauthorize these programs?

These programs have expiration dates set by law; Congress must pass legislation to renew them so the FDA can continue collecting these fees.

News Coverage

No news coverage found yet. Articles are indexed twice daily.

Discoveries

Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.

policy shift90% confidence

Routine Reauthorization Cycle

The hearing follows a standard legislative pattern of reauthorizing expiring user fee programs to maintain FDA operational funding.

Food and Drug Administration

Connected Entities

organizationAnimal Health Institute“Industry trade association for animal health companies”Map →

personMichael C. Burgess“Chairman of the Subcommittee on Health”Map →

organizationAmerican Veterinary Medical Association“Professional association for veterinarians”Map →

organizationGeneric Animal Drug Alliance“Industry group representing generic animal drug manufacturers”Map →

personSteven Solomon“Director, Center for Veterinary Medicine, FDA”Map →

organizationFood and Drug Administration“Federal agency responsible for animal drug regulation”Map →

Sources

Open source document

www.govinfo.gov

Analysis Score

0–100

Significance60
How much this matters to a regular citizen
Controversy10
Intensity of disagreement among stakeholders
Entertainment5
Compellingness for a non-policy-wonk reader
Buzz10
Current news / social attention level

Publisher tools