FEDERALhearing transcript

Congressional Hearing on FDA Drug Approval Fees

Original title: EXAMINING FDA'S GENERIC DRUG AND BIOSIMILAR USER FEE PROGRAMS

January 1, 2018

FDA generic drugs biosimilars user fees healthcare policy drug regulation

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The Frame

What this does

The hearing addresses the funding mechanisms that allow the FDA to review and approve generic and medications, which directly impacts the speed at which lower-cost alternatives to brand-name drugs reach the market.

Who is mentioned in the record

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

Pharmaceutical Manufacturers

These companies pay user fees to the FDA to facilitate the drug approval process.

FDA

The agency manages the user fee programs and uses the revenue to fund its review operations.

Patients

The efficiency of the FDA approval process influences the availability and cost of generic and biosimilar drugs.

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 s for s and s. The hearing examined how these programs are managed and their impact on the drug approval process.

Key Facts

The hearing was held on March 2, 2017, by the House Subcommittee on Health.
The primary focus was the reauthorization and oversight of FDA user fee programs for generic drugs and biosimilars.
User fees are payments made by drug manufacturers to the FDA to support the review process for new drug applications.
The hearing included testimony from FDA officials, health policy experts, and representatives from the pharmaceutical industry.
The committee received statements from the Federal Trade Commission regarding the drug market.
Several witnesses provided prepared statements and answers to follow-up questions for the official record.

Frequently Asked Questions

What are FDA user fees?

User fees are funds collected by the FDA from pharmaceutical companies to help cover the costs of reviewing and approving new generic and drug applications.

Why does the government hold hearings on these fees?

Hearings allow Congress to oversee how the FDA uses these funds and to determine if the programs are effectively helping to bring affordable medications to market.

Why It Matters

News Coverage

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Discoveries

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

policy shift90% confidence

FDA Funding Model

The hearing highlights the reliance of the FDA on industry-paid user fees to maintain its regulatory review capacity.

Food and Drug Administration

Connected Entities

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

organizationAssociation for Accessible Medicines“Industry trade association”Map →

personJanet Woodcock“Director, Center for Drug Evaluation and Research, FDA”Map →

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

organizationThe Pew Charitable Trusts“Represented by witness Allan Coukell”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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