The Report Is Out — And the Numbers Are Damning

The Taxpayers Protection Alliance released "Blocking Breakthroughs: Delays and Denials at the FDA" on March 26, 2026. The findings aren't subtle.

FDA drug approval costs hit $50 million per medication in 2025 — up from roughly $30 million in 2015, according to TPA. That's a 67% jump in a decade, and it only covers administrative costs. Clinical trial expenses are on top of that. Billions more.

The 2025 rejection rate came in at nearly 30% — near decade highs — according to TPA Executive Director Ross Marchand. More money flowing in, more drugs getting blocked.

What's New: The Promised Fix Isn't Fixing Anything

RFK Jr. and FDA Commissioner Dr. Marty Makary came in promising to streamline the agency, cut red tape, and get life-saving drugs to patients faster. The TPA report says flatly: that is simply not happening.

Marchand put it directly: "For too long, the FDA has stood in between patients and life-saving treatments. New leaders at the helm of HHS and FDA 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 report specifically calls out five drugs — Ebvallo, ONS-5010, High-Dose Spinraza, Hetlioz, and Gefapixant — as examples of FDA risk aversion that's actively harming consumers. These aren't fringe treatments. Spinraza treats spinal muscular atrophy. Patients are waiting.

The Layoff Problem Nobody Wants to Talk About

HHS under RFK Jr. executed a reduction-in-force targeting nearly 3,500 FDA employees, roughly 20% of the agency's workforce, according to the American Council on Science and Health. The administration said frontline reviewers were spared. That claim is falling apart.

According to ACSH citing STAT News reporting, scores of FDA drug reviewers — people who were explicitly protected from layoffs — are actively looking to leave. Industry recruiters are picking them up. The work environment has become, in the words of those interviewed, "morose."

RFK Jr. railed against the revolving door between FDA staff and drug companies. His own department's actions have accelerated that dynamic, according to ACSH.

The Contradiction at the Heart of This Story

Conservatives rightly want a leaner, faster FDA. The TPA report backs that up with hard data and proposes real solutions: approval reciprocity with other nations, outcomes-based data, more over-the-counter access.

But there's a difference between cutting bureaucratic fat and gutting institutional capacity. Firing the people who review drug applications — or creating an environment so chaotic they voluntarily walk out — doesn't speed up approvals. It buries them.

The FDA regulates products that account for over 20 cents of every consumer dollar spent in America, per ACSH. You can't just hollow that out and call it efficiency.

One Personnel Note That Matters

The TPA report mentions that Vinay Prasad — Director of FDA's Center for Biologics Evaluation and Research — played a key role in a bizarre decision to refuse examination of Moderna's application for its first mRNA seasonal flu vaccine, before the agency walked that back. Prasad is reportedly leaving the agency soon.

That reversal on the Moderna mRNA flu vaccine application was a real-time example of the dysfunction the TPA report is documenting. An application gets rejected, public pressure mounts, the decision gets reversed. That's not a streamlined process.

What's Being Missed

Left-leaning outlets are running with the layoff story as proof that Trump is destroying public health. Right-leaning outlets are cheering the downsizing as bold reform, missing the part where the people walking out the door are the drug reviewers — exactly the people you need if you want faster approvals.

The FDA was already dealing with structural problems before the cuts. The layoffs have compounded the issue rather than fixed it.

What This Means For You

If you or someone you know is waiting on a treatment — for SMA, for a rare disease, for anything caught in FDA limbo — the pipeline is NOT clearing. It may be getting more clogged.

The TPA report gives Congress a roadmap: reciprocal approvals with trusted allies, smarter outcome metrics, OTC expansion. Those are common-sense solutions that don't require destroying the agency to implement.

Right now, the FDA has more money, more authority, new political leadership — and worse outcomes.