Paying for Drug Approvals — Who's Using Whom?

From the New England Journal of Medicine

By Jerry Avorn, MD

SUMMARY: In this NEJM Perspective, Dr. Avorn examines the implications of the FDA's growing reliance on user fees paid by the pharmaceutical industry to fund its drug approval operations. The piece raises structural conflict-of-interest concerns: when the agency regulating an industry derives a significant share of its operating budget from fees paid by that same industry, questions arise about whether the agency's independence and standards may be affected. Avorn reviews the history of the Prescription Drug User Fee Act and its successive reauthorizations, examining evidence about their effects on approval timelines, the volume of post-market safety actions, and the relationship between the FDA and the industry it regulates. (Note: Full text paywalled; summary based on publicly available title, description, and field context.)

BACKGROUND: The Prescription Drug User Fee Act allows the FDA to collect fees from pharmaceutical manufacturers seeking drug approval, using these funds to accelerate review timelines. The agency's growing dependence on these fees raises questions about regulatory independence.

KEY FINDINGS: Not fully retrievable from publicly available text; article is paywalled. The piece examines the structural conflict-of-interest created when the drug regulator is financially dependent on fees from the industry it regulates.

IMPLICATIONS: The FDA's user-fee funding model creates structural incentives that may subtly tilt regulatory decisions, warranting careful examination of how the agency's independence and evidence standards are maintained.