Abortion drug ruling could fuel mistrust in the FDA

Last week's federal court ruling overturning the FDA's approval of a commonly used abortion drug was unprecedented, but experts say it's evidence of an escalation of mistrust in the agency that's been building for years.

Why it matters: The ruling — which calls into question the drug's safety in a way at odds with scientific consensus — could further fuel skepticism about public health agencies that was fomented by anti-vaccine activists and amplified during the pandemic by misinformation about COVID vaccines.

The big picture: The ruling can be seen as both an extension of growing public distrust as well as new fuel for it.

• "The court's rebuff of scientific facts … undermines informed decisions, erodes trust in institutions, exacerbates social divides, and places individual and collective health at risk," the American Medical Association said in a statement on the ruling.

What they're saying: "This is another assault on FDA and its expertise that isn’t, in this case, particularly based on strong data, but does the job of effectively promoting mistrust in the agency decision," said Ameet Sarpatwari, an assistant professor at Harvard Medical School and the assistant director of the Program On Regulation, Therapeutics, and Law at Brigham and Women’s Hospital.

• "It's one thing to have a debate about the evidence that the FDA is considering, but to really selectively present statistics and ignore a wide body of evidence, and to do from a position of power and trust as a federal judge … really provides a record for people who are distrustful of the FDA to begin with and distrustful of the administrative state of a whole," he added.

Between the lines: The FDA's decision-making is often subject to scrutiny within the scientific community, and experts both within and outside of the agency have recently debated topics ranging from covid booster shots to the agency's expedited approval of new Alzheimer's drugs.

• Some experts have argued that the FDA's decisions in these realms have undermined its own credibility.
• "Some of the approvals for the vaccines — especially the boosters, not the initial approvals — did not inspire confidence and could have been conducted in a way that would have built trust,” said Céline Gounder, a senior fellow at KFF.
• But courts "simply don't have the scientific and medical expertise to be making these decisions," she added. The decision is “part of a broader movement of not deferring to science and expertise."

By the numbers: There's a strong partisan divide when it comes to public trust in the FDA, according to new Ipsos polling provided to Axios, with Democrats more likely to believe the agency is acting in good faith.

• When asked how well "guided by facts and science" describes the FDA, only 6 percent of Republicans said very well, compared with 29 percent of Democrats. In contrast, 17 percent of Republicans said not well at all, compared with 4 percent of Democrats.

• An Axios-Ipsos poll from the end of September 2020 found 69 percent of Democrats said they had a great deal or a fair amount of trust in the agency to look out for the best interests of them and their family. 66 percent of Republicans said the same.
• "The federal agencies central to the pandemic response are still struggling to win back Republicans. The presidency going from a Republican to a Democrat and the polarizing rollout of the COVID vaccine all likely contribute to Republicans' diminishing trust," said Sarah Feldman, a senior data journalist at Ipsos.

The partisan divide is reflected at the congressional level, where Republicans are navigating a thorny divide between pandemic oversight — including of the vaccine approval process — and questions that have been debunked by data.

The bottom line: "We operate in a system in which it is really the credibility of the FDA that sustains the pharmaceutical industry, that gives prescribers a comfort in prescribing an FDA-approved drug and … patients in taking those drugs," Sarpatwari said.

• "In the long run, it seems there is a coordinated effort of a death by a thousand cuts."

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