Editorial: An erratic FDA is a threat to innovation
Published in Op Eds
Few corporate cautionary tales are as vivid as the rise and fall of Moderna Inc. During the pandemic, the company’s mRNA vaccine was approved and distributed in record time, saving millions of lives and turning a once-obscure startup into a $200 billion behemoth.
Now Moderna is in a tight spot: Hundreds of millions of dollars in grants for mRNA shots were rescinded last year, one of the company’s newest products is in limbo, and its market value has dwindled to about a 10th of its pandemic-era high.
What happened? In large part: politics.
As the COVID-19 outbreak eased, demand for vaccines inevitably fell. Yet White House officials also changed their tune. Out went the optimism about mRNA and in came wild theories that this miraculous, Nobel Prize-winning technology wasn’t safe. By way of defending this posture, the country’s top drug official recently said Moderna and its peers “can fund their own research.”
This sentiment couldn’t be more self-defeating. Combined with the administration’s erratic regulation and policymaking, it threatens to undo the salutary ecosystem that made Moderna such a success in the first place.
Consider the company’s latest flu vaccine. In early February, the Food and Drug Administration refused to review data for its application, despite working closely with the company since 2024. Although regulators had flagged some concerns about Moderna’s trial design — mainly, they wanted the control group to receive a higher-dose vaccine — officials appeared to support its workaround (submitting data from a separate, smaller trial) as recently as August.
On Feb. 3, however, senior vaccine regulator Vinay Prasad refused to review Moderna’s application, citing the company’s failure to run an “adequate and well-controlled” trial. Such refusal letters are rare and typically reserved for applications with egregious omissions. (By some accounts, Prasad overrode his staff in writing it.) Another senior official suggested the company “show some humility” before asking the FDA to reconsider its application. Moderna proposed a revised approach.
The FDA ultimately came to its senses and agreed to review Moderna’s file, reportedly after the White House intervened. Yet it’s still far from certain whether the shot will be approved — and the agency’s chaotic approach has already taken a toll. Venture-capital investment in mRNA vaccines has fallen 65% since 2023. One investor said recently that vaccines are “radioactive.”
Worryingly, the upheaval is extending to other treatments, including rare-disease drugs, that also involve costly, yearslong clinical trials. In such cases, a regulator swayed by ideological impulses can do lasting damage. Large drug companies may pivot to tried-and-true products rather than risky innovations, or take their investments in lifesaving treatments elsewhere. Smaller biotechs might never get started. The public is the biggest loser.
Prasad, for his part, will be leaving the agency next month, and the administration appears to be softening its anti-vaccine stance ahead of midterm elections. Although investors appear encouraged by such developments, the impact could be short-lived. Health Secretary Robert F. Kennedy Jr. has done little to disavow vaccine skepticism and has a habit of empowering personnel with unfounded fixations in this area. The administration, and Congress, should demand a steady hand at the FDA.
Underpinning Moderna’s success was the nation’s decades-long commitment to predictable regulation. The White House jeopardizes that principle at its peril — and everyone else’s.
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The Editorial Board publishes the views of the editors across a range of national and global affairs.
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