FDA Under Fire as Report Cites Soaring Costs, Rising Drug Rejections

WASHINGTON, DC – March 26, 2026 – The U.S. Food and Drug Administration is facing renewed scrutiny over its drug approval process, with a blistering new report from the Taxpayers Protection Alliance (TPA) alleging that soaring administrative costs and a rising tide of rejections are preventing life-saving medications from reaching patients.

The report, titled "Blocking Breakthroughs: Delays and Denials at the FDA," argues that the agency has become increasingly risk-averse, to the detriment of public health. It paints a picture of a regulatory body caught between its mandate for safety and the urgent needs of patients, a tension that new leadership at the Department of Health and Human Services (HHS) and the FDA has pledged to resolve.

"For too long, the FDA has stood in between patients and life-saving treatments," said Ross Marchand, Executive Director of the TPA, in a statement accompanying the report. "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."

The High Cost of Caution

At the heart of the TPA's critique are stark figures on cost and rejection rates. The report claims the FDA's administrative costs have skyrocketed from roughly $30 million per medication in 2015 to over $50 million in 2025. This figure, the TPA notes, does not include the billions of dollars pharmaceutical companies spend on clinical trials.

While the TPA's specific methodology for calculating this "administrative cost" is unique, the underlying trend of rising expenses in drug development is well-documented. Application filing fees paid by companies to the FDA, known as user fees, have steadily climbed, surpassing $4.3 million for a new drug application in fiscal year 2025. These fees are intended to fund the FDA's review activities, but they represent only a fraction of the total cost—estimated to be as high as $2.6 billion—to bring a single new drug to market.

More alarming to patient advocates is the report's finding that the FDA's rejection rate for new drugs reached nearly 30 percent in 2025, a figure described as a near-decade high. While the TPA's number is on the higher end of estimates, other industry analyses confirm a troubling trend. A Q3 2025 report from RBC Capital Markets, for instance, found that marketing application rejections climbed to 15%, up from a historical average of 10%, with an additional 11% of reviews being delayed.

Patients Caught in the Regulatory Crossfire

The TPA report argues that these statistics are not just numbers on a page but represent real-world consequences for patients. It highlights five specific medications—Ebvallo, ONS-5010, High-Dose Spinraza, Hetlioz, and Gefapixant—as case studies of the FDA's alleged over-caution.

One prominent example cited is a higher-dose formulation of Spinraza, a treatment for the devastating neurodegenerative disease spinal muscular atrophy. According to TPA, the FDA declined to approve the new dose not over safety or efficacy concerns, but due to "insufficient technical information" in the manufacturing section of its application. To critics, it was a case of paperwork taking precedence over a proven therapy.

Similarly, the report points to Hetlioz, a medication that has been available to patients in Europe since 2022. The TPA alleges that the FDA has hindered its path to American patients by citing "fixable deficiencies at third-party manufacturing sites." These instances, the alliance contends, reflect a pattern of regulatory hurdles that delay or deny access to treatments for vulnerable populations.

A New Era of Reform Meets Old Challenges

The TPA's criticism comes as the FDA and its parent department, HHS, are under new leadership with a stated mandate for reform. HHS Secretary Robert F. Kennedy Jr. has championed a policy of "radical transparency," while FDA Commissioner Dr. Marty Makary has publicly committed to "accelerating cures" and "cutting red tape."

One of the administration's signature initiatives has been the public release of over 200 Complete Response Letters (CRLs) between July 2025 and early 2026. These letters, which detail the FDA's reasons for not approving a drug, were historically kept confidential. The agency's leadership argues that making them public provides crucial predictability for drug developers, helping them avoid common pitfalls and ultimately speeding up the approval process.

However, these reform efforts are running into significant headwinds. The FDA is reportedly grappling with high staff turnover and budget cuts that have led to review delays and postponed inspections, creating a bottleneck that frustrates biotech companies and their investors. Venture capitalists have noted that the unpredictable timelines increase risk, making it harder for innovative early-stage companies to secure funding.

The Unending Balancing Act

Internally, the push for speed has created friction. Some agency scientists have reportedly raised concerns about new fast-track programs, worrying that they are being pressured to skip steps and that final approval authority is shifting from career scientists to political leadership. This internal tension was highlighted when the agency recently delayed reviews for several high-priority drugs, citing scientific concerns over safety and efficacy data, a move that frustrated developers but was seen by some regulatory experts as a reassuring sign of the agency's commitment to scientific rigor.

The situation leaves the FDA in a precarious position, caught between intense public and political pressure to accelerate approvals and its foundational duty to ensure that all drugs sold in the U.S. are safe and effective. The TPA report proposes its own solutions, including approval reciprocity with allied nations and a greater reliance on outcomes-based data.

As policymakers debate these proposals, the core challenge remains: how to modernize the drug approval process to foster innovation and provide rapid access to breakthroughs without compromising the safety standards that Americans have come to expect from the world's most influential regulator.