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US biotech company Roivant Sciences has moved to distance itself from its founder, Vivek Ramaswamy, after the Republican presidential contender alleged that the US Food and Drug Administration was “corrupt” and said it should be gutted.
Matt Gline, Roivant’s chief executive, told the Financial Times that Ramaswamy was no longer associated with running the company following his decision in February to stand down as chair to run for president.
“Vivek and I are different people,” Gline said in an interview. “Vivek is not associated with Roivant right now other than as a shareholder. Vivek’s views on FDA are different than my personal views on FDA and different than Roivant’s views on FDA.”
“We have an enormous amount of respect for FDA as our regulator,” he added.
The comments from Gline, a former Goldman Sachs banker who replaced Ramaswamy as Roivant’s CEO in 2021, come as the company’s subsidiary, Dermavant, prepares to ask the FDA to approve a drug to treat eczema.
The skin cream Vtama and another Roivant-backed drug in development targeting inflammatory bowel disease could become multibillion-dollar opportunities if they get the green light from the FDA, according to Jefferies, an investment bank.
Ramaswamy, who owns 7 per cent of Roivant, has enjoyed a bump in Republican primary polls in recent weeks, but remains in third place behind former president Donald Trump and Florida Governor Ron DeSantis.
The 38-year-old former biotech entrepreneur, whose campaign for the White House is based on a pledge to vanquish the “woke left”, lashed out at the FDA in a video posted to X, formerly Twitter, last month.
“When it comes to agencies like the FDA, boy, do I know their corruption,” Ramaswamy said. “One agency I have been waiting for a long time to expose and to ultimately gut, is much of the FDA itself.”
Ramaswamy’s criticism of the FDA has alarmed some former colleagues and academics, who note the candidate’s near-$1bn personal fortune was based mainly on drug approvals by the regulator.
“It marks to me a deep hypocrisy,” said Don Berwick, a former administrator of the US Centers for Medicare and Medicaid, who resigned as a member of Roivant’s advisory board in 2021.
Ezekiel Emanuel, a bioethicist and vice-provost for global initiatives at University of Pennsylvania, told the Financial Times Ramaswamy’s comments on the FDA were “outrageous”.
“Maybe he never heard of Thalidomide and the need to protect Americans from promising but ultimately dangerous drugs,” said Emanuel, adding that he once spoke at a Roivant event.
“There is a reason for safety testing and then testing for effectiveness. We don’t want Americans hurt or wasting money on unproven and ineffective drugs . . . like an Alzheimer’s drug called Intepirdine,” he said.
Ramaswamy earned part of his fortune by touting the promise of Intepirdine, an experimental Alzheimer’s medicine he acquired from GSK for just $5mn in 2015.
Ramaswamy purchased the medicine via Roivant, his drug development group, before creating a subsidiary named Axovant to develop it. Axovant filed for an initial public offering that raised $315mn, securing a valuation of almost $3bn after the first day of trading. In 2017 the drug failed a clinical trial, triggering a collapse in Axovant’s shares that cost many investors millions of dollars.
But Roivant has since diversified its business and helped develop six drugs which gained FDA approval. It has a market capitalisation of $9bn.
Ramaswamy has dismissed Berwick’s criticism as “politically motivated”, pointing out that he headed up the Centers for Medicare and Medicaid during Barack Obama’s administration.
In a statement to the Financial Times, Ramaswamy said: “I developed an Alzheimer’s drug. Like 99.7 per cent of all drugs tested for Alzheimer’s disease, it failed.”
He also reiterated his criticism of the “‘hypocritical, harmful and unconstitutional” FDA.
“For years I was coached by industry veterans not to speak out against FDA. It’s well known that if you anger FDA, they will punish you by blackballing review of your drug-review applications . . . Well, they could only shut me up for so long. Now I speak freely as a citizen.”
The FDA did not reply to a request for comment.
Gline, who joined Roivant in 2017, said criticism of the Axovant IPO and Ramaswamy had been sensationalised by the media.
“It’s much less fun to talk about Vivek as a thoughtful entrepreneur who built a business and had some wins and some losses and ultimately that business has graduated from his involvement than it is to talk about him as a music man, huckster, who like oversold something,” he said.
“But you know, the honest truth is like, he was an honest biotech entrepreneur who had some wins and losses.”
Gline defended Roivant’s handling of the Axovant IPO.
“So was it hyped? Probably, but I’ll be very upset if you just quote that one sentence out of context. Was it hyped more or differently than any other biotech IPO of that era or since? I think, probably not,” he said.
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