FEDERALhearing transcript

Hearing on FDA Prescription Drug User Fee Program

Original title: EXAMINING FDA'S PRESCRIPTION DRUG USER FEE PROGRAM

January 1, 2018

FDA prescription drugs healthcare policy user fees drug approval process

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The Frame

What this does

The program allows the FDA to collect fees from pharmaceutical companies to fund the drug review process, directly impacting the speed and resources available for bringing new medications to market.

Who is mentioned in the record

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

Pharmaceutical Industry

Companies pay user fees to the FDA to support the drug approval review process.

FDA

The agency receives funding through user fees to manage its drug evaluation and research operations.

Patients

The efficiency of the drug review process impacts the timeline for new medications reaching the market.

What changed

Last recorded activity January 1, 2018.

What's next

Next step not available in the current record.

Summary

This document is a transcript of a 2017 House Subcommittee on Health hearing regarding the FDA's Prescription Drug User Fee Act () program. The hearing featured testimony from FDA officials and industry representatives to examine the program's effectiveness and future reauthorization.

Key Facts

The hearing took place on March 22, 2017, in the Rayburn House Office Building.
The session focused on the reauthorization and examination of the Prescription Drug User Fee Act (PDUFA) program.
Witnesses included representatives from the FDA, the Biotechnology Industry Organization, and the Pharmaceutical Research and Manufacturers of America.
The subcommittee received formal statements from advocacy groups including the Epilepsy Foundation and the National Organization for Rare Disorders.

Frequently Asked Questions

What is the Prescription Drug User Fee program?

It is a program where the FDA collects fees from drug manufacturers to help fund the costs associated with the review of human drug applications.

Why was this hearing held?

The hearing was held to examine the performance and future needs of the program as part of the legislative process for its reauthorization.

Why It Matters

The program allows the FDA to collect fees from pharmaceutical companies to fund the drug review process, directly impacting the speed and resources available for bringing new medications to market.

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

Industry-FDA Collaboration

The hearing highlights the established reliance on industry-funded fees to sustain federal regulatory operations.

Food and Drug Administration Pharmaceutical Research and Manufacturers of America

Connected Entities

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

personJanet Woodcock“M.D., Center for Drug Evaluation and Research, FDA”Map →

personKay Holcombe“Senior VP of Science Policy, Biotechnology Industry Organization”Map →

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

personAnne Pritchett“VP of Policy and Research, Pharmaceutical Research and Manufacturers of America”Map →

personJeff Allen“President and CEO, Friends of Cancer Research”Map →

Sources

Open source document

www.govinfo.gov

Analysis Score

0–100

Significance65
How much this matters to a regular citizen
Controversy20
Intensity of disagreement among stakeholders
Entertainment5
Compellingness for a non-policy-wonk reader
Buzz10
Current news / social attention level

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