The civic record
Read. Follow. Verify.Senate Hearing on FDA User Fee Programs
Record date · January 1, 2023
Track this bill to get notified when it advances a stage. One tap to stop, anytime.
What This Bill Does
The Senate Committee on Health, Education, Labor, and Pensions held a hearing to discuss the of four Food and Drug Administration (FDA) user fee programs. These programs allow the FDA to collect fees from medical product companies to fund the review and regulation of drugs, devices, and other medical products.
The of these programs determines the FDA's funding levels and regulatory capacity for reviewing new medical products, which directly impacts the speed and safety of bringing new treatments 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.
Medical product manufacturers
These companies pay user fees to the FDA to support the regulatory review process for their products.
FDA
The agency relies on these fees as a significant portion of its operating budget for product reviews and inspections.
Patients
Patients are affected by the speed and safety standards applied to the medical products they use.
Key Facts
- The hearing focused on the reauthorization of four distinct FDA user fee programs.
- User fee programs allow the FDA to collect funds from industry to support the review of medical products.
- The FDA is responsible for regulating approximately 80 percent of the U.S. food supply.
- The FDA conducts inspections of thousands of food, drug, and device manufacturing sites annually.
Show all 7 facts
- The committee received testimony from representatives of the healthcare industry, medical device manufacturers, and policy research organizations.
- The hearing included a review of in-person medical product inspection counts from fiscal years 2017 to 2021.
- The committee accepted written responses to questions from Senators regarding the user fee agreements.
Frequently Asked Questions
What are FDA user fee programs?
Why does the Senate need to reauthorize these programs?
What else do you want to know?
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.
Focus on Inspection Data
The inclusion of specific inspection counts from FY17 to FY21 suggests a legislative focus on the FDA's oversight performance during the pandemic era.
Connected Entities
Sources
www.govinfo.gov
Analysis Score
0–100- Significance80How much this matters to a regular citizen
- Controversy20Intensity of disagreement among stakeholders
- Entertainment5Compellingness for a non-policy-wonk reader
- Buzz10Current news / social attention level
Publisher tools