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# FDA May Be Too Reliant on User Fees: Professor
- URL: https://www.fdaweb.com/fda-may-be-too-reliant-on-user-fees-professor/
- Published: 2021-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:58:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149319

University of Connecticut Department of Pharmacy Practice head **C. Michael White** says FDA may have become too dependent on industry user fees and is not sufficiently funded for work not covered by those fees. In an online [column](https://theconversation.com/why-is-the-fda-funded-in-part-by-the-companies-it-regulates-160444?ref=fdaweb.com) at *The Conversation*, White traces the history of FDA funding from full congressional funding through the start of user fees for prescription drugs during the AIDS crisis and the spread of user fees to other agency programs, including animal drugs, generic drugs, and medical devices.

He discusses some of the benefits of user fees, including that FDA is quicker and more willing to discuss what it wants to see in an application with manufacturers. It also offers clearer guidance to manufacturers, White says. As a result, the time between when an NDA is submitted by a manufacturer and the agency makes a decision on it has dropped from 29 months in 1987 to 10 months in 2018\. He also says changes in FDA procedures have increased the number of standard NDAs approved in the first cycle from 38% in 2005 to 61% in 2018.

But, he says, “while the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious issues coming to light after FDA approval.”

He concludes that user fees are a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market. “Successes have occurred and provided U.S. citizens with medication more quickly than before,” he writes. “However, without careful consideration of what is being negotiated, FDA can become weak and ineffective, unable to protect its citizens from the next thalidomide. There are some signs that the pendulum may be swinging too far in the direction of manufacturers. Additionally, while the approval functions at FDA are well funded, FDA is insufficiently funded to protect consumers from other issues such as counterfeit drugs and dietary supplements because they cannot collect user fees to do so. In my view, these functions need to be identified and require additional taxpayer funding.”