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# Harvard Law Hits User Fees Over ‘Corporate Capture’
- URL: https://www.fdaweb.com/harvard-law-hits-user-fees-over-corporate-capture/
- Published: 2026-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:30:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160462

A [new analysis](https://petrieflom.law.harvard.edu/2026/01/08/worst-of-both-worlds-fdas-funding-structure-corporate-capture-and-political-interference/?ref=fdaweb.com) from Harvard Law School argues that the U.S. drug regulator’s reliance on industry-paid user fees has left the agency vulnerable to both corporate influence and political interference, undermining the rigor of drug approvals and potentially putting patients at risk. In a blog post published Jan. 8, author **Danny Finley** contends that the user fees, which account for nearly half of the agency’s budget, has failed to insulate regulators from political pressure while simultaneously opening the door to what critics describe as corporate capture. The result, Finley writes, has been drug approvals based on limited or inconclusive evidence of safety and effectiveness.

User fee supporters point to measurable gains. For example, FDA’s drug review center doubled its number of divisions, eliminated a backlog of applications and committed to faster review timelines under its user fee program. Reauthorization of the fees every five years has also given Congress a regular opportunity to revisit agency priorities.

But Finley argues those benefits come at a cost. Former agency leaders and academic critics have long warned that the arrangement reframes regulated companies as “customers,” incentivizing regulators to accommodate industry demands. Negotiations over user fee reauthorizations routinely involve extensive industry input, a dynamic some scholars say gives manufacturers unusual influence over approval standards.

The analysis points to high-profile cases as evidence of that influence. One is Aduhelm, an Alzheimer’s therapy approved despite a negative recommendation from an FDA advisory committee and disputed efficacy data. The drug later failed commercially and was withdrawn amid continuing questions about its benefit. Another example is Elevidys, a Duchenne muscular dystrophy treatment approved after its Phase 3 trial missed primary endpoints. Internal reviewers found the data insufficient to support effectiveness claims, but the drug was cleared anyway. Former FDA chief scientist **Luciana Borio** later called the decision “a mockery of scientific reasoning.” The agency subsequently narrowed the drug’s indication and added a warning after reports of fatal liver failure in two patients.

Beyond industry pressure, Finley argues the funding structure does little to protect the agency from politics. Unlike independent regulators like the Federal Reserve, FDA sits within the executive branch and remains subject to presidential control. Under the current administration, nearly 3,500 FDA employees were laid off last July, a move critics say could slow reviews and weaken oversight. User fees also do not shield the agency from government shutdowns, during which fee collections stop.

Meanwhile, some former leaders have urged Congress to convert FDA into an independent agency, a proposal supported by seven former commissioners. Finley notes, however, that recent Supreme Court rulings have cast doubt on the long-term viability of such structures.