The Numbers Are Stark

The Taxpayers Protection Alliance released a report on March 26, 2026 titled "Blocking Breakthroughs: Delays and Denials at the FDA."

FDA drug approval costs have skyrocketed 67% — from roughly $30 million per medication in 2015 to more than $50 million in 2025, according to the TPA report. That's just the administrative cost. Clinical trial expenses add billions more on top.

Meanwhile, the FDA is spending all that extra money to reject more drugs. The 2025 rejection rate hit nearly 30 percent — close to a decade-long high. More money in. Fewer drugs out.

Five Drugs That Shouldn't Be Waiting

The TPA report calls out five specific medications the FDA has stonewalled through excessive risk aversion: Ebvallo, ONS-5010, High-Dose Spinraza, Hetlioz, and Gefapixant. These are treatments with real patients waiting on the other side.

Ross Marchand, Executive Director of the Taxpayers Protection Alliance, said: "For too long, the FDA has stood in between patients and life-saving treatments. Bureaucrats need to get out of the way and put patients first."

The DOGE-Era Promise vs. Reality

This report is an indictment of the current administration's own people.

Robert F. Kennedy Jr. at HHS and Dr. Marty Makary at the FDA both campaigned on reforming this exact problem — faster approvals, less bureaucratic interference, more patient access. The TPA report says flatly that "this is simply not happening."

Fox News flagged the story but framed it mostly as ammunition against the old guard. The inconvenient truth is that the new guard is now running this agency. If rejection rates are near decade highs in 2025, that is happening under the current administration.

The TPA report notes that Vinay Prasad, Director of FDA's Center for Biologics Evaluation and Research, played a key role in controversial decisions — including an initial refusal to even examine Moderna's application for its first mRNA seasonal flu vaccine. Prasad will soon be leaving the agency.

This Isn't New — It's a Decades-Long Failure

The FDA's approval bottleneck isn't recent. A 1998 editorial published in the British Medical Journal — co-authored by Scott Gottlieb, who would later become FDA Commissioner himself — documented the same tension: an agency accused simultaneously of moving too slowly and too fast depending on who was complaining that week.

The debate has "raged since 1962," according to that BMJ piece. Sixty-plus years of the same argument. No resolution.

Life Extension Magazine, drawing on peer-reviewed research, calculated that more than 8 million Americans may have died due to the 37-year delay in making metformin — now a standard, cheap, widely prescribed diabetes drug — available in the United States. Even if the real number is lower, it represents a catastrophic policy failure measured in human lives.

What Reform Actually Looks Like

The TPA outlines concrete fixes:

• Approval reciprocity with trusted allied nations — if a drug clears regulators in the EU, UK, or Japan, fast-track it here
• Outcomes-based data — broaden the types of clinical evidence the FDA will accept
• Over-the-counter expansion — let more medications skip the prescription gatekeeping entirely

These reforms don't require blowing up the agency. They require the people currently running it to follow through on what they said they would do.

What This Means for Regular People

If you or someone you love is waiting on a treatment that exists but isn't approved, a federal agency is the reason. Not a pharmaceutical villain. Not an insurance company. A federal agency spending $50 million per drug to reject more than ever before.

Taxpayers fund the FDA. Drug companies pay user fees to the FDA. Patients wait.

The Trump administration ran on fixing government dysfunction. Health and Human Services represents government dysfunction with measurable human cost. If Makary and Kennedy can't bend those rejection rates down and cut those approval costs, the public has a right to demand accountability.