RFK Jr. has been warning anyone who'll listen that China is eating our lunch in medical research and drug development. 

He's right about the trend. 

He's running the agency that's making it worse.

Let’s name some names, starting with ClearPoint Neuro. ClearPoint makes the neurosurgical navigation platform that gene therapy companies use to deliver treatments directly into the brain with millimeter precision. 

If you're trying to cure Huntington's disease by injecting an engineered virus into the exact right spot in the basal ganglia, ClearPoint is how you do it. They're the picks-and-shovels play on brain gene therapy.

CLPT has been getting crushed. Not because anything is wrong with ClearPoint. Not because their platform stopped working. Because their customers — the gene therapy companies that use their platform — are being systematically destroyed by the Food and Drug Administration.

Consider uniQure. They're developing a one-time gene therapy for Huntington's disease. Huntington's, if you've never had the misfortune of watching someone die from it, is a hereditary neurodegenerative disorder. A hundred percent fatal. Destroys a person's mind and motor control over fifteen to twenty years. Parents pass it to children, guaranteed, if they carry the gene. There is no treatment. Zero.

uniQure's Phase 1/2 data showed a 75% slowing of disease progression over three years. In a disease that is currently 100% fatal, with no approved disease-modifying therapies, that result would normally send a stock to the moon. Instead, the FDA created procedural barriers that the clinical community considers disproportionate. The market has punished QURE ever since.

Consider Replimune. On April 10, the FDA rejected its oncolytic virus therapy, RP1, for metastatic melanoma for the second time. RP1 is a modified herpes virus injected directly into tumors. It causes the cancer cells to burst and trains the immune system to attack tumors throughout the body. 

In patients whose melanoma no longer responds to checkpoint inhibitors — patients who typically die within a year — RP1 produced tumor shrinkage in nearly all treated patients. 

One-third went into remission. One in six had tumors disappear completely. The FDA rejected it because the trial wasn't randomized against a control group, even though randomizing terminal cancer patients to no treatment is considered unethical by virtually every melanoma expert in America.

Three companies. Three therapies for serious or fatal diseases. Three stories of American biotech being dismantled by a regulator that changed its mind about what counts as acceptable clinical evidence — without ever changing its rules on paper.

And they are not the only ones.

Meanwhile, Joe Rogan Gets His Magic Mushrooms

Now, let me tell you what the same FDA has been greenlighting during this same period.

Psychedelic mushrooms for recreational wellness. Ibogaine research funding. Loosened rules on peptides sold through compounding pharmacies with minimal clinical trial data — BPC-157, TB-500, all the biohacker favorites. A general regulatory posture that is friendly to whatever modality appeals to the populist base.

Huntington's patients losing their minds — told no.

Melanoma patients dying within a year — told no.

Joe Rogan gets his mushrooms.

Let's be clear about what's happening. Real companies developing real therapies for real diseases are being destroyed, while themodalities that appeal to the populist base get the red carpet. That is not a scientific philosophy. That is a cultural filter dressed up in lab coats.

They Changed the Rules in the Middle of the Game

Here's the part that should make your blood boil.

The companies I named above, and there are additional examples, didn’t stumble into these rejections because they ran sloppy clinical trials or submitted incomplete applications. They ran trials designed in consultation with the FDA itself. They received breakthrough therapy designations. They received orphan drug designations. They received pre-submission guidance from agency reviewers on exactly how their trials should be structured.

And then, somewhere between the submission of those trials and the agency's decisions on them, the rules changed.

The previous regulatory framework accepted single-arm trials with natural history controls for rare, fatal diseases in which randomized controlled trials were ethically impossible. The previous framework honored breakthrough designation as a meaningful signal of regulatory flexibility. The previous framework used advisory committees to adjudicate difficult decisions in public, with expert input, under institutional scrutiny.

The FDA under Commissioner Marty Makary and biologics chief Vinay Prasad quietly replaced all of that without ever formally changing a single regulation. Single-arm trials that were previously acceptable became unacceptable. Breakthrough designations that previously meant something became meaningless. Advisory committees that had previously served as institutional shock absorbers for difficult decisions simply stopped being convened. The agency's operational behavior shifted. The regulations on paper did not.

That isn’t a tightening of scientific standards. That’s a retroactive policy change imposed on companies, patients, and investors who relied on the prior framework in making their decisions. In the plain-English phrase that captures it best: they changed the rules in the middle of the game.

And the legal community has noticed. On Monday, April 20, Covington & Burling — the most prestigious FDA regulatory law firm in Washington — filed a formal citizen petition on behalf of an unnamed pharmaceutical company. The petition argues that the FDA's September 2025 decision to release Complete Response Letters for unapproved drugs publicly violates federal confidentiality law, the Trade Secrets Act, and the agency's own regulations. 

The petition cites the 2025 Supreme Court decision in FDA v. Wages & White Lion Investments for the proposition that an agency changing its policy must “provide a reasoned explanation for the change, display awareness that” it is “changing position, and consider serious reliance interests.”

That citation is the legal frame for the larger argument. The Makary FDA changed its operational approach without acknowledging the change, without a reasoned explanation, and without considering the reliance interests of companies that designed billion-dollar clinical programs based on the prior framework. That is, in the view of the most sophisticated FDA lawyers in the country, unlawful.

When Covington files a petition on behalf of an unnamed client, the industry reads it as the whole industry speaking through one voice. Nobody casually picks this kind of fight with their regulator.

China Is Eating Our Lunch — And Here's Who Is Feeding Them

RFK Jr. has been warning for months that China is overtaking the United States in medical research and drug development. "China is now eating our lunch," he told Congress. He's not wrong about the trend. It's a real problem, and it deserves serious attention.

Here's the problem with that warning, coming from this Health and Human Services Secretary.

The FDA, under his leadership, is operating a policy that makes the China problem worse, not better. The September 2025 decision to publish unredacted Complete Response Letters online means that every time the FDA rejects an American drug application, the detailed clinical deficiencies the agency identifies become public intelligence available to any Chinese competitor who wants to avoid the same pitfalls. American companies pay to discover what the FDA doesn't like. Chinese competitors get the answer for free.

Meanwhile, the American companies whose technologies represent our actual leadership position against China — the gene therapy platforms, the oncolytic virus programs, the novel biologics for rare diseases — are the exact companies getting kneecapped by retroactive regulatory policy changes.

You cannot simultaneously argue that China is eating our lunch and preside over an agency whose operational behavior is structured to feed it to them. That contradiction is politically unsustainable. One of the two positions has to give.

I predict the FDA's operational behavior will shift to match the administration's rhetorical position on China, rather than the other way around. Because the administration cannot afford to let "China is winning" remain true, given the decisions it itself is making.

The Grim Reaper Is Leaving

Here's what's actually happening, below the surface.

Vinay Prasad — the FDA biologics chief the Wall Street Journal editorial board called "the grim reaper" in the piece they published two weeks ago demanding Replimune's RP1 be approved — is stepping down at the end of this month. 

The Journal has since run a second editorial and published a patient letter continuing the pressure campaign. John Carroll, founder of Endpoints News and the most respected biotech journalist in the business, observed this week that "at this point, REPL's whole future rests with the op-ed page of the WSJ, and they are dug in. Agree or disagree, you have to admire the sheer doggedness of it."

RFK went before the Senate Finance and House Ways and Means Committees and tried to defend the RP1 rejection, claiming the trial was "one arm with chemotherapy." That's factually wrong. The trial combined RP1 with nivolumab, an immunotherapy, not chemotherapy. 

When the highest-ranking defender of a regulatory decision gets the trial design wrong in sworn Congressional testimony, the political case for the decision collapses. You do not testify with errors like that if you have confidence in your position.

REPL jumped 22% the day RFK defended the rejection. Read that sentence again. The stock rose when the HHS Secretary publicly backed the agency that had rejected the company's drug. That is not how markets respond to dead stocks. That is how markets respond when the defenses are so weak that the market concludes the decision cannot hold.

The specialist investor community is publicly demanding an advisory committee. Melanoma physicians sent an unsolicited letter to the FDA. Patient advocacy is organizing. Covington is litigating. The Wall Street Journal is not backing off. And the architect of the rejection is walking out the door in a few days.

This one is not over.

The (Massive) Opportunity

I see a category of American biotech companies — CNS gene therapy, oncolytic immunotherapy, rare disease therapeutics — that have been battered by a regulatory regime whose operational behavior is politically, legally, and strategically unsustainable. 

I see a pressure campaign assembling in public view, across every legitimate institutional channel in American life. I see the departure of the specific regulator most identified with the damage. After months of hoping the situation would resolve quietly, I see a pharmaceutical industry that has finally decided to go to federal court if necessary.

When that campaign produces its outcome, a basket of stocks reprices. Not because the underlying science changed. Because the regulatory environment that punished them reverts to something resembling its pre-Makary state, and prior valuations that were correct about the science all along.

The companies ruined by rules changed in the middle of the game will be the beneficiaries when those rules are successfully challenged. 

Which is what is happening, right now, in plain view.