Vivek Ramaswamy wants to ‘gut’ the FDA. His claims don’t hold up to scrutiny

STAT readers know Vivek Ramaswamy from his time as the founder of the biotech conglomerate Roivant — and for his role in some of its various subsidiaries and spinoffs. Of course, the world now knows Ramaswamy for a very different reason: He’s running for president, and has made the cut to participate in the first debate of the Republican primary.

Earlier this month, Ramaswamy posted a video on Twitter trading on his biotech bona fides to talk about his plans to “expose and ultimately gut” the Food and Drug Administration.

“And when it comes to agencies like the FDA, boy, do I know their corruption,” said Ramaswamy.

Not surprisingly, as reporters who have both followed Ramaswamy for years and reported extensively on the FDA, we have some thoughts on this. We sat down to talk them over.

Matt: Ramaswamy has always struck me as one of the best debaters I’ve ever met, but what surprised me is how much of this just strikes me as hyperbole and misrepresentation.

Adam: I’ve spent a big part of my journalism career investigating and exposing biotech hype and false claims. These comments about the FDA from Ramaswamy are nonsense, made worse because he’s not a stock-promoting, snake-oil peddler. He’s a smart guy, who previously ran a legitimate biotech company, now seeking to become president.

Matt: Let’s talk in more detail about Ramaswamy’s remarks. The FDA, he said, “exercises authority far beyond what the law envisioned when the FDA was ever created in the first place.”

His worst example is going after the Covid vaccines. He speaks about Covid vaccines being “pushed through under political circumstances in less than a year” to make it sound as if they weren’t studied.

These products were studied in some of the biggest approval trials I’ve ever seen, and Ramaswamy certainly knows that. There were tens of thousands of patients in each pre-approval study, with hard impacts measured on infection and for some vaccines hospitalization. Yes, this was unprecedented, but we were in a global crisis.

Adam: Ramaswamy goes on to falsely blame the FDA for Covid vaccine mandates. However you feel about the jab requirements, these were not set by the FDA. The FDA’s role is to determine the efficacy and safety of vaccines, or drugs. Whether or not vaccines or drugs should be required is a policy decision made by other government officials, scientific bodies, and, yes, even the private sector.

Matt: Of course, he’s using the vaccines as a straw man to bolster another favorite issue for the conservative base: the right to try medicines that have not been tested if you have no other hope.

“This is an agency that is fundamentally hostile to patient’s right to try medicines, including lifesaving medicines,” he said. “They will say, no, no, no, unless it’s gone through the billions of dollars and 10-plus years of testing.”

It’s a common argument that the FDA is what’s making it difficult for patients to get access to these medicines. But there are a lot of other factors — including that doctors and drug companies don’t really have any incentive to prescribe medicines that cannot be marketed yet.

Adam: You and I have both spent a lot of time reporting on the FDA in recent years. Most of the criticism of the agency has centered on regulatory flexibility, which in real terms, has made it easier for drugs to be approved and reach the market, often before it’s determined if patients actually benefit. Ramaswamy wants his followers to believe that the FDA is blocking access to medicines. This is false.

Matt: There is a libertarian fantasy that keeps coming up — it emerged in the early days of the last administration before Trump made Scott Gottlieb the FDA commissioner — that we’d basically be better off without an FDA. What we really need the FDA to do, the argument goes, is ensure drugs are “safe” without worrying about efficacy.

Ramaswamy seems to be arguing that this is the case. But let’s not forget he came onto the scene trying to develop an Alzheimer’s drug that had been abandoned by one of the large pharmaceutical companies. In his public comments, he seemed very convinced it would be effective.

When his company, Axovant, did the trials that were mandated by the FDA, it was very clear the medicine was not effective. I don’t think allowing Ramaswamy to have sold that medicine without proving it worked would have been a good idea.

Adam: It’s worth noting that the right-to-try legislation signed into law in 2018 while Trump was president actually takes decision-making about patient access to experimental medicines out of the FDA’s oversight. The FDA’s role is limited to receiving and compiling information on right-to-try access to medicines. The decision to grant patients access is made by drugmakers.

Matt: And the reality is that the new right-to-try law has been used sparingly. If we want to make experimental drugs more accessible to patients, a lot of things have to change, including the willingness of doctors to use them.

To a drug company, making a drug available before it can be sold has a lot of downsides. Maybe Ramaswamy is right that on some level this sours the relationship between the company and regulators at the FDA. But is getting rid of the FDA really the answer to that problem?

Adam: We can cite a bunch of studies that show the right-to-try law hasn’t worked as intended, including this study from 2021 that showed community oncologists had greater success accessing experimental drugs for patients through existing compassionate use programs than through the right-to-try law. The FDA almost never turns down compassionate use applications.

Matt: I do want to give Ramaswamy credit for something in this debate.

“Everybody in the pharma industry, it’s a quiet little adage,” he said. “They say, oh, no, FDA never forgets. You can’t criticize them or they’ll penalize you for the drugs that you’re applying to advance.”

People definitely say this. And there is some truth to it. I do think there are examples where the FDA seems to be being extra careful with companies that in the past did something it thought was unwise. I’m not sure that this is something one can get rid of when regulators are people who have past experience with the people they are regulating. It may well be one impediment to right to try — that drug companies are afraid to make medicines available because of the FDA.

Adam: Agreed, but is it a reason to “gut” the FDA? Absolutely not. Back in my early days of biotech reporting, I wrote a series of investigative pieces about a company developing an artificial oxygen-carrying substitute for human blood. The product got pretty far along in testing and was even being considered for use by the U.S. military to treat critically wounded soldiers. There was one big problem: The experimental blood substitute caused terrible kidney damage, including cases of kidney failure. The company was suppressing this safety information. I think about this when I hear people like Ramaswamy advocating for the dismantling of the FDA.

Matt: We can both tell so many horror stories. I always go back to Vioxx, the Merck painkiller that was withdrawn from the market for causing heart attacks. But there have been so many cases where a drug turned out to have safety problems. Sometimes I think companies would have found out about those problems and withdrawn the drug because it was the right thing to do. But I certainly believe some of those harmful medicines would still be on the market, being pushed with nonstop TV ads, if there were not a regulator keeping score.

Requiring companies to study their drugs often leads us to figure out other ways to help people. It’s how we figured out that some diabetes drugs can prevent heart attacks, and probably helped lead to all the obesity medicines that are coming out now. Originally, those studies were just meant to prove the diabetes medicines didn’t cause heart attacks.

Adam: Ramaswamy suggests that because he once ran a drug company, but is now a “free man,” running for president, he speaks the truth about the FDA. The implication is that people still attached to the biotech and pharmaceutical industry secretly hate the FDA and are afraid to criticize the agency. The truth is that by an overwhelming majority, people who work to develop and sell medicines respect the FDA and oppose any effort to get rid of it. An FDA approval helps them sell drugs.

Ramaswamy is a free markets guy, but he conveniently forgets to mention that allowing unsafe or ineffective products to reach the market is bad for business. Ramaswamy said the FDA is hostile to patients, but that’s illogical when you consider that more new drugs are being approved than ever before.

He may take issue with drug pricing, but again, the FDA doesn’t set drug prices.

Matt: Another rhetorical sleight of hand. Ramaswamy says: “This is an organization that now exercises authority far beyond what the law envisioned when the FDA was ever created in the first place.”

Sure, when the FDA was founded in 1906, it was basically given the power to stop the sale of outright poison. But its powers were expanded over time for a reason. One of the biggest moments was the FDA’s refusal to approve thalidomide as a treatment for morning sickness. The drug caused serious birth defects and was withdrawn in 1961.

That helped lead Congress to demand that FDA demand manufacturers prove drugs were not only “safe” but “effective.” That’s where a lot of the current FDA structure comes from, and we’re often arguing about what those mean. Personally, I wish the FDA’s mandate were different, to show that the benefits of medicines outweigh their risks, because few drugs really qualify as “safe.” They all have side effects, sometimes scary ones.

Adam: One of the hallmarks of Ramaswamy’s early run for the presidency has been his flippant criticism of government agencies he doesn’t like. He’s promised to defund the Department of Education, shut down the Federal Bureau of Investigation, and radically rework the Federal Reserve. So, from that perspective, I guess it was only a matter of time before the FDA landed in his cross hairs.

Matt: I understand that lots of people dislike regulation and have a dim opinion of bureaucrats and view it all as the deep state. But I really question how many people really want to live in a world where medicines go completely unregulated. This is not a plan that any other developed country has gone with, and we already see so much fraud and hype in medicine.

I get that it’s red meat for a certain segment of the Republican base, but this feels like the kind of discussion that just leads us to never solve any of our actual problems.