New TPA Report Finds FDA Costs Soaring, Drug Rejections Rising

For Immediate Release

Contact: Kara Zupkus (224) 456-0257

WASHINGTON, D.C. – Today, the Taxpayers Protection Alliance (TPA) released a report, “Blocking Breakthroughs: Delays and Denials at the FDA,” highlighting the many issues with the Food and Drug Administration’s (FDA’s) drug approval process. The report comes amid continued controversy over the agency insisting on unrealistic and ethically-fraught criteria for approvals and walking back a bizarre decision to refuse to examine an application by Moderna for its first mRNA seasonal flu vaccine. Fortunately, FDA Center for Biologics Evaluation and Research Director Vinay Prasad—who played a key role in these decisions—will soon be leaving the agency.

Key report findings include:

• FDA drug approval costs have increased significantly over the past ten years, skyrocketing from roughly $30 million per medication in 2015 to more than $50 million in 2025.
  • This only includes administrative costs borne by the agency—and taxpayers and drug sponsors by extension—and does not include billions of dollars in clinical trial expenses.
• Even as the FDA has more taxpayer dollars and user fees at its disposal, rejections are becoming increasingly common. The 2025 rejection rate of nearly 30 percent was near decade highs.
• The FDA’s approach to five medications in particular (Ebvallo, ONS-5010, High-Dose Spinraza, Hetlioz, and Gefapixant) reflects continued risk aversion that harms consumers.

Ross Marchand, Executive Director of the Taxpayers Protection Alliance, offered the following comment:

“For too long, the FDA has stood in between patients and life-saving treatments. New leaders at the helm of the Department of Health and Human Services (HHS) and FDA, such as Robert F. Kennedy Jr. and Dr. Marty Makary, have promised to make America healthier and bolster patient access to care. This report shows that is simply not happening, and millions of Americans are paying the price. Bureaucrats need to get out of the way and put patients first.

“There are plenty of steps the FDA and Congress can take to improve the drug approval process and expand access. Promising reforms include approval reciprocity with other nations, embracing a wider variety of outcomes-based data, and allowing more medications to be sold over the counter. With the right combination of changes, long-stalled drugs can finally come to market and be easily accessed by patients.

“It’s long past time for FDA reform. Policymakers need to step up and do right by patients. Millions of Americans will benefit from a faster and more reliable drug approval process.”

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The Taxpayers Protection Alliance (TPA) is a non-profit, non-partisan organization dedicated to educating the public through the research, analysis, and dissemination of information on the government’s impact on the economy.