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The president has nominated Dr. Heidi Overton to be the next Commissioner of the FDA. She’ll be up for Senate confirmation at some point in the next few months presumably. Is she up to the task?

A good place to start is: What is the job, and how prepared to do a good job is she?

FDA is basically a regulatory agency. It oversees most foods moving in interstate commerce (including imports); prescription and over-the-counter drugs; vaccines; medical devices; tobacco products; cosmetics; and animal drugs and feed.

And it’s huge. FDA’s budget is $7B ($3.4B in appropriations and $3.6B in industry user fees. They have (or I should say had before DOGE) 18,200 FTEs, but after Kennedy implemented DOGE cuts, they only have 16,000 employees now.

So, the commissioner oversees roughly 16,000 employees, laboratories, inspectors and regulatory operations around food, drugs and animal products around the country and overseas.

FDA can’t wing the way it regulates foods and drugs. Their authority comes from statutes enacted by Congress (mostly the Federal Food, Drug, and Cosmetic Act and its amendments). Over decades FDA has adopted detailed regulations to guide their regulatory actions in Title 21 of the Code of Federal Regulations.

When FDA makes regulatory decisions or changes regulations, they’re supposed to follow federal administrative procedures (including notice-and-comment rulemaking) and they have to stay within their statutory and administrative boundaries. They have discretion, but they also have strict boundaries.

When people are adversely impacted by FDA decisions think FDA got it wrong, they’re not shy about suing FDA. Judges examine whether the agency stayed within its statutory authority, followed required procedures, applied their regulations properly and adequately explained its decision.

FDA decisions therefore have to survive not only scientific scrutiny but often judicial review because they’re a regulatory agency.

So… the FDA commissioner needs more than scientific credentials. The job requires leadership, administrative experience, discipline, and regulatory competence.

Oddly enough, Congress says nothing about the qualifications the FDA commissioner is supposed to have. 21 U.S.C. §393 says the commissioner is nominated by the president and confirmed by the Senate. There’s no required degree, scientific background, regulatory experience or management experience. That’s inadequate.

Arizona actually does somewhat better. ARS §36-102 requires the ADHS director to have administrative experience with progressively increasing responsibilities; an educational background preparing the director for the position’s administrative responsibilities; and health-related experience ensuring familiarity with health problems.

Those qualifications aren’t perfect, but at least they recognize the need for subject-matter knowledge and administrative experience.

Congress does spell out the FDA commissioner’s duties. The law says the commissioner provides “overall direction,” establishes and implements policies for FDA management and operations, and coordinates and oversees its administrative entities.

So how does Overton stack up?

Her medical and scientific background is good. She earned an M.D. from the University of New Mexico, trained in surgery at Johns Hopkins, earned a Ph.D. in Clinical Investigation from the Johns Hopkins Bloomberg School of Public Health and is board-certified in Public Health and General Preventive Medicine. Her peer-reviewed research includes work on opioid prescribing and improving physician practice using data.

She also has some policy experience. She served as a White House Fellow, became Chief Policy Officer at the America First Policy Institute and now serves as Deputy Director of the White House Domestic Policy Council.

She also served as a voting member of the University of New Mexico Board of Regents. The American College of Preventive Medicine notes that her specialty includes training in epidemiology, biostatistics and health-systems management.

The weak part of her résumé is large-scale operational management and a lack of regulatory experience. I can’t find any evidence that she has run a major agency, managed large numbers of employees or ran a complex regulatory organization.

There’s also a separate question about scientific independence. In a 2023 interview, Overton called for “conservative-based” scientific journals and alternative research infrastructure. She has also advocated restrictions on mifepristone from an explicitly anti-abortion policy perspective.

Overton appears to be scientifically qualified and has some policy experience. But (and this is really important for a huge regulatory agency) she really doesn’t have any executive and no regulatory experience.

There’s also a risk that her political viewpoints could override whatever past professional commitments she’s had to evidence-based decision making.

And for a regulatory agency as big and as important as the FDA… that’s a big question-mark. If she is rogue in the end, at least we still have checks and balances in the constitution and a fairly independent federal judiciary as a backstop.

Editorial Note: One reason I’m comforted a bit by the prospect of the public health damage an administrator Overton could do is the Supreme Court’s 2024 decision in Loper Bright Enterprises v. Raimondo, which overturned the 40-year-old Chevron deference doctrine.

Under Chevron, when a statute passed by Congress was in question, courts generally deferred to a federal agency’s reasonable interpretation of the law.

The Loper Bright case changed that. The Supreme Court held that under the Administrative Procedure Act, judges are supposed to independently assess what federal statutes mean rather than deferring to an agency’s interpretation.

I wasn’t enthusiastic about that ruling when it came out because it shifted authority away from subject-matter experts in federal agencies and toward judges.

But… there’s another side to it. If an ideologically driven FDA commissioner pursues an ideological agenda and makes inappropriate regulatory decisions federal courts now have way more authority to overturn federal agency decisions