The civic record
Read. Follow. Verify.Hearing on FDA Prescription Drug User Fee Program
Record date · January 1, 2018
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What This Bill Does
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.
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 It Affects
Groups the bill's text affects, as described in the record. Being affected is not a position for or against it.
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.
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
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News Coverage
Follow the record
Votes, people, money & the original sourceFull breakdown
Who this bill affects and the strongest case for and against it, written only from the bill’s own text.
Discoveries
Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.
Industry-FDA Collaboration
The hearing highlights the established reliance on industry-funded fees to sustain federal regulatory operations.
Connected Entities
Sources
www.govinfo.gov
Analysis Score
0–100- Significance65How much this matters to a regular citizen
- Controversy20Intensity of disagreement among stakeholders
- Entertainment5Compellingness for a non-policy-wonk reader
- Buzz10Current news / social attention level
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