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# Watchdog Blasts FDA Over Rising Costs, Higher Rejections
- URL: https://www.fdaweb.com/watchdog-blasts-fda-over-rising-costs-higher-rejections/
- Published: 2026-03-26T12:00:00.000Z
- Updated: 2026-09-14T13:36:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160884

A conservative-leaning advocacy group is taking aim at FDA, arguing in a new report that the agency’s drug review process has grown more costly and restrictive — potentially slowing patient access to new therapies. In a [report](https://edge.prnewswire.com/c/link/?t=0&l=en&o=4650844-1&h=1864213157&u=https%3A%2F%2Fwww.protectingtaxpayers.org%2Fwp-content%2Fuploads%2F2026%2F03%2FBlocking-Breakthroughs-Delays-and-Denials-at-the-FDA-v3.pdf&a=a+report%2C&ref=fdaweb.com) titled *“Blocking Breakthroughs: Delays and Denials at the FDA,”* the Taxpayers Protection Alliance said FDA administrative costs tied to drug approvals have climbed sharply over the past decade, rising from roughly $30 million per drug in 2015 to more than $50 million in 2025\. The group noted those figures exclude the far larger clinical trial costs borne by sponsors.

The report also points to what it describes as a tightening regulatory environment, citing a drug rejection rate approaching 30% in 2025 — near a decade high — despite increased agency funding from both taxpayers and industry user fees.

TPA argues the trend reflects growing risk aversion at the agency, highlighting several recent regulatory decisions it says exemplify the issue, including reviews involving Ebvallo, ONS-5010 and high-dose Spinraza.

The report lands amid broader political scrutiny of FDA’s decision-making, including controversy over the agency’s handling of an application from Moderna for an mRNA-based seasonal flu vaccine. The agency had initially declined to review the filing before reversing course, drawing criticism from industry observers.

Leadership changes could further shape the agency’s direction. CBER director **Vinay Prasad** was a key figure in several recent regulatory decisions, and he is expected to depart the agency next month.

In a statement, TPA Executive Director **Ross Marchand** said FDA is “standing in between patients and life-saving treatments,” and called for reforms including reciprocal approvals with other countries, broader use of real-world evidence, and expanded over-the-counter access. The group also pointed to leadership at HHS under **Robert F. Kennedy Jr.** and FDA commissioner **Marty Makary**, arguing that promised efforts to speed approvals have yet to materialize.