FDA user fees : examining changes in medical product development and economic benefits / Sonal Parasrampuria and Trinidad Beleche.

Format:

Book

Author/Creator:

Parasrampuria, Sonal, author.

Beleche, Trinidad, author.

Language:

English

Subjects (All):

Cost effectiveness.

Equipment and supplies--economics.

Equipment and supplies.

Physical Description:

1 online resource (1 PDF file (13 pages)) : illustrations

Other Title:

FDA user fees

Place of Publication:

Washington, D.C. : ASPE, Office of the Assistant Secretary for Planning and Evaluation, 2023.

Summary:

The Food and Drug Administration (FDA) assesses and collects user fees to supplement Congressional appropriations. In fiscal year (FY) 2022, user fees represented 46% (2.9 billion) of FDA's total budget of 6.2 billion. User fees vary substantially across FDA programs. In FY2022, across FDA's medical product centers, user fees accounted for 1.4 billion (66%) of the human drugs program budget, 197 million (43%) of the biologics program budget, and 228 million (35%) of the medical device program budget. Research evidence suggests that user fees have contributed to increased access to new medical products for patients and reduced review timelines for industry. The benefits of user fees can be substantial for industry and patients. Using public and proprietary data from 2000 to 2018, we estimate that between 0.5% and 2.0% of the total cost of developing a new drug, complex medical device, or preventive vaccine went towards user fees. Using data from 2013 to 2021, we estimate that 1.7% of the total cost to develop a generic drug went towards user fees.

Contents:

Introduction

History of User Fees

EVIDENCE ON USER FEES

Discussion and Conclusion.

Notes:

Description based on publisher supplied metadata and other sources.