‘Uncertainty Rules’ at FDA: Henry Miller

Former 15-year FDAer Henry Miller, now an American Council on Science and Health distinguished fellow, says uncertainty rules as FDA awaits the confirmation of commissioner-designate Martin Makary. Writing in his personal Pundicity online blog, Miller says that while specific priorities for Trump 2.0 are not yet clear, regulated industries “are bracing for possible changes in drug, device, biologics, and food regulation.”

He notes that legally, the ultimate authority for all FDA approvals is the HHS secretary, who delegates that authority to the commissioner, who may further delegate it down the organizational chart. “In other words,” Miller writes, “even if Makary advocates somewhat rational FDA policies, not a given in this administration, he ultimately takes his marching orders from Robert F. Kennedy, Jr., the delusional, science-challenged, anti-vaccine activist and ‘chemtrails’ conspiracy theorist. RFK, Jr., could arbitrarily interdict FDA approvals he didn’t like.”

Miller cautions there may not be that much policy difference between Makary and Kennedy given Makary’s “dubious opinions during the Covid-19 pandemic.” He says Makary criticized what he saw as overly harsh vaccine mandates and was one of a group that urged a greater emphasis on herd immunity to end the pandemic. “Predictions by Makary and other signees to the Great Barrington Declaration that as few as 20,000 people in the U.S. were likely to die from Covid infections ended up being off by 1.3 million — a mere 6,400%,” Miller declares.

He says that while ongoing agency activities like application reviews and inspections are expected to continue, some high-profile initiatives such as regulating laboratory-developed tests and digital health products may face delay or revision.

Miller also discusses the impact of the 2024 Supreme Court decision ending the Chevron doctrine under which courts granted agencies considerable deference in interpreting their authorities. With the Supreme Court saying that judges must interpret agency authority, rather than deferring to the agency, problems can arise since many, if not most, judges lack the specialized knowledge needed to decide what is appropriate.

“This decision is likely to reverberate across FDA policymaking and enforcement,” he says…. “Without the requisite expertise, judges tasked with ruling on the legality of new rules and regulatory decisions will inevitably make some fragmented inconsistent decisions that vary across jurisdictions. As these cases proceed through the courts, FDA may need to adapt its practices to conform to the new judicial dictates. And there is a broader fear that the overturning of Chevron undermines the role of science in U.S. rulemaking, as it shifts the burden of interpreting ambiguous laws from federal agencies to courts and special interests, potentially hindering science-based regulation and public health protections.”

Miller predicts that artificial intelligence and digital health will likely remain central to FDA’s agenda, although with unanswered questions about how the new administration is likely to address these areas through regulations.

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Miller concludes that the “interplay among political leadership, regulatory priorities, and industry innovation will define FDA’s trajectory under the new administration. While some changes may streamline processes and foster innovation, others could slow progress or introduce uncertainty in key areas. Collaboration among regulators, industry, public interest groups, and other stakeholders will be essential to ensure that regulatory frameworks protect public health while supporting innovation. It won’t be an easy task.”