For about 20 minutes on Thursday, President Trump undermined six decades of dogma on the development of safe and effective drugs.
Trump, addressing a nation under shelter and quarantine from the coronavirus pandemic, said a new drug for Covid-19, yet to be proved safe and effective, was now “approved or very close to approved.” Another, also not approved for coronavirus, would be “available almost immediately,” in part because using it is “not going to kill anybody.”
Then, minutes later, the commissioner of the Food and Drug Administration, Stephen Hahn, took the dais in the White House briefing room and delicately walked back each one of Trump’s statements. Nothing about the FDA’s deliberate process had changed, and no miracle medicine was a pen stroke away from solving the crisis. Pharma stocks that had surged fell back again.
The president’s remarks ran afoul of nearly every established FDA norm — prizing data and evidence over rhetoric, for instance, and avoiding promises, let alone those that can’t be kept. But they were also a sign of his long-running impatience with the realities of drug development — an impatience that is flaring at a time when the need for new medications seems more urgent than ever.
“Trump entered the White House fuming at bureaucrats, moaning about the deep state, but in particular trying to bring down the FDA,” said Arthur Caplan, professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics. “That’s pure ideology, and it turns out that ideology is barren and impotent in the face of a pandemic.”
In many ways Trump’s science policy has been defined by his disdain for red tape at the FDA. At nearly every turn he has equated the agency’s success not with its scientific rigor or its role as a watchdog but with faster drug approvals and the slashing of regulations.
Shortly after being elected, Trump turned to billionaire Peter Thiel to help vet candidates to lead the FDA and other science agencies. Among those candidates was Jim O’Neill, a staunch libertarian, who championed the idea of letting the FDA approve drugs without proving they were effective. During his first address to Congress, in 2017, Trump chided the agency for its “slow and burdensome” approval process, despite the fact that the FDA in recent years had acted faster than ever before.
And he has repeatedly touted the passage of the so-called “right to try” law — which gives dying patients access to experimental drugs that have completed basic Phase I clinical trials — despite expert concerns about it.
The White House spent months spearheading support for that legislation despite prolonged efforts by patient groups that insisted it was both unnecessary — the FDA already has a process in place to give patients access to experimental drugs — and dangerous because it would open dying patients up to exploitation by unscrupulous companies.
In fact, experts say, the law has had minimal impact, with only a handful of cases in which patients have used it.
The coronavirus pandemic has rekindled Trump’s eagerness to expedite the development of new medicines. But in this case the process of developing new therapies is already moving at an unprecedented pace. The first potential vaccine, developed by Moderna Therapeutics, went from a lab experiment to human trials in less than three months, a process that commonly takes years. Gilead began enrolling thousands of patients in its remdesivir studies just weeks after case studies suggested the drug might help with Covid-19.
The FDA, once dismissed by Trump as disruptively sluggish, gave its blessing to both trials immediately.
“The FDA has been a global leader in medical product development,” said Jeff Allen, president and CEO of Friends of Cancer Research. “There’s nothing to suggest that they are standing in the way of the important development and access to these therapies.”
Still, the bracing pace may not be enough for Trump. The Wall Street Journal reported this week that the White House pushed for an executive order dramatically expanding the use of investigational drugs against the coronavirus, but was met with objections from the FDA. And on Thursday, it was up to Hahn to serve as a fact-checker to the commander-in-chief.
“That was a commendable appearance under immense pressure,” said Daniel Carpenter, a professor at Harvard University who studies the history and reputation of the FDA. “Commissioner Hahn did the right thing.”
Most FDA watchers can recite by heart the history of how the agency was granted the ability to review drugs for safety and efficacy in the first place. It wasn’t until a so-called “elixir” that was being promoted to cure sore throats killed over 100 people that Congress acted in 1938 to give the FDA the ability to regulate drugs for safety. Decades later, in the 1960s, a drug promoted to help with morning sickness led to thousands of babies born with lifelong birth defects. The crisis prompted Congress to again boost the FDA’s power. Among those changes were some requiring the FDA to not just consider safety, but also efficacy, when approving drugs.
Those are responsibilities that the FDA still holds dear.
“Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective. And we are continuing to do that,” Hahn said Thursday.