pharmaceutical

“I am very annoyed”: Pharma execs blast RFK Jr.’s attack on vaccines

Waiting for the midterms

But pharmaceutical executives don’t appear comforted by the pushback. “Today it may be childhood vaccines or mRNA, but tomorrow it’s everything,” Noubar Afeyan, co-founder and chairman of Moderna, maker of mRNA vaccines, said. “We have to say not just ‘why is this happening?,’ but ‘Where will it stop?’”

As a bad flu season is underway, Dean Li, president of Merck Research Laboratories, noted that the anti-vaccine rhetoric is hitting seasonal flu shots. “With the pressure on vaccination, I cannot foresee flu vaccination increasing in this country over the next three years,” he said in a presentation.

Sanofi Chief Executive Paul Hudson had a similarly pessimistic outlook. “It’s clear this administration has a particular sensitivity around vaccination, and indeed pediatric vaccination,” Hudson said. “I’m asked all the time ‘what are you going to do to fix this?,’ and the truth is we just need to stay extremely objective and continue presenting the evidence. There’s really very little else we can do,” except wait for the midterm elections, he said.

“We will have to maintain a steely focus on the long-term future of vaccines and deal with any uncertainty around vaccine coverage rates in the short-term based on misinformation, Facebook posts, and statements from the top,” he said.

Bourla also worried about the conditions Kennedy is creating to attack drug makers. Kennedy, who is an environmental lawyer with no scientific or medical background, has profited from lawsuits against vaccine makers, as have many of his allies and advisors. “There is also a lot of plaintiffs’ playbook there,” Bourla said. “Everybody will start litigating.”

FDA described as a “clown show” amid latest scandal; top drug regulator is out

drug, fda, george tidmarsh, health, pharmaceutical, vinay prasad / Mike M. / November 4, 2025

In September, Tidmarsh went after Tang’s Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide “hard” clinical benefit and that the drugmaker had not performed necessary trials.

Such a post from the FDA’s top drugmaker turned heads. Aurinia claims its share price fell 20 percent in a matter of hours, dropping $350 million in market value.

“Embarrassing”

Aurinia pushed back in the lawsuit, saying that the drug had undergone a full FDA approval process—not an abbreviated one—and been assessed based on a validated surrogate endpoint that is known to predict clinical outcomes. Further, the drug has been approved for use in 36 other countries in addition to the US.

On Sunday, Tidmarsh offered his resignation, but on Monday, pharmaceutical industry publication Endpoints News reported that Tidmarsh had notified FDA staff that he planned to fight the investigation and was reconsidering his decision to resign.

If the allegations in Aurinia’s lawsuit are true, Tidmarsh’s behavior would be egregious for a federal regulator. But already, the claims and other scandals have outsiders concerned that the high-stakes “soap opera” is destroying the agency’s credibility, as Stat reported Tuesday.

“We are witnessing nothing less than a clown show at FDA right now,” one venture capital investor told the outlet. “For the sake of patients, we need a stable and consistent FDA!”

“What’s happening at the top of the FDA is embarrassing,” a portfolio manager at a large biotech fund added. “How am I supposed to convince people, other investors, that this sector is doing important work when the leaders of the FDA are acting this way?”

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