WASHINGTON — Nearly every person who’s run the Food and Drug Administration in recent history agrees the agency should break free from its political supervisors — a rare consensus from commissioners who served under Republican and Democratic administrations alike.

In two papers published Monday, all seven of the FDA’s most recent commissioners wrote that the current setup — in which the agency is a mere subdivision of the Department of Health and Human Services — interferes with the ability of its scientists to protect the health of the public. They described a situation in which a tangled web of responsibilities, along with political overseers who aren’t necessarily motivated by science, all make it harder for the FDA to keep people safe.

“This is really a plea to reduce the short-term political influence in favor of long-term policy,” said Dr. Robert Califf, FDA commissioner from 2016 to 2017, and a co-author of the papers.


Sometimes, that political influence has exploded into the public view, most notably in 2011 when then-HHS Secretary Kathleen Sebelius overruled then-FDA Commissioner Dr. Margaret Hamburg’s decision to allow emergency contraception to be sold over the counter. In October, Dr. David Kessler, FDA commissioner from 1990 to 1997 and a co-author of the paper, related a time when an HHS official gave him a list of people who should be appointed to an advisory committee. The list went into the trash.

And, of course, the fate of the FDA is tied up with the fate of the rest of government, which is on display right now during the partial shutdown. Though about 60 percent of the agency is still operational, 40 percent of the FDA’s personnel are furloughed and key operations have halted. The FDA, for example, is not currently accepting any new drug applications.

“We’ve got a government shutdown going on that’s very much affecting FDA even though its issues are not really closely related to the areas of policy disagreement at all,” said Dr. Mark McClellan, FDA commissioner from 2002 to 2004, and a co-author of the paper.

Four of the FDA’s most recent commissioners all admitted to STAT the push for independence is still in its infancy, even after years of consideration. They acknowledged that though they’ve been batting around the ideas together since 2016, modifying the agency’s structure — which would require a change to federal law — is unlikely to happen any time soon.

“I don’t think that there’s much appetite in this current environment to take this on, with everything else that’s swirling around,” said Hamburg, who led the FDA from 2009 to 2015 and co-authored the papers.

Hamburg said that she has been thinking about this for a long time — including when she held the job. At one point, she said, Rep. Anna Eshoo (D-Calif.) even started working on a bill on the topic, but it never went anywhere. Eshoo’s office declined to comment.

The most recent round of revolutionary thinking — culminating in the two papers published Monday — was facilitated by the Aspen Institute, and funded by the Laura and John Arnold Foundation. The Aspen Institute published one of the papers, and Health Affairs published the other.

Ruth Katz, executive director of the Health, Medicine, and Society Program at the Aspen Institute, said that the recommendations do not reflect the opinions of the Aspen Institute and that no one at the Arnold Foundation nor the FDA played a role in developing the reports.

In the papers, the former commissioners didn’t say exactly what they wanted a reconstituted FDA to look like. Perhaps a cabinet-level regulatory department like the Environmental Protection Agency? Or an independent agency like the Federal Trade Commission?

Dr. Andrew von Eschenbach, FDA commissioner from 2006 to 2009 and a co-author, said he initially favored cabinet-level status. Hamburg said that setup would put too much political pressure on the agency. McClellan said that either approach would be better than the status quo, and Califf said he didn’t have a preference, adding that he wasn’t “expert enough” to know the advantages or disadvantages of either setup.

Currently, the former commissioners said, the FDA’s position within HHS means that other HHS agencies get to have a say in FDA policymaking — quite simply, there are too many cooks in the kitchen. And some of those people at HHS might know nothing about the intricacies of FDA policy.

“You get bogged down, also, in a way that’s frustrating, by individuals at different levels in the hierarchy of review not having the background and expertise,” Hamburg said.

Or, Hamburg said, by individuals who have normal human preferences and just happen to be in high places. She recalled many a phone call she received from the White House by people who liked particular drugs and weren’t happy when the FDA recalled them.

One source of influence that the reports do not address is the regulated industries. Dr. Sidney Wolfe, founder of Public Citizen, a nonprofit advocacy group that often critiques the FDA, called the idea that removing FDA from HHS would solve the agency’s problems a “dreamland” scenario.

“Industry pressure is not going to relinquish itself or diminish,” Wolfe said.

Correction: An earlier version of this story misstated the outcome of the 2011 decision related to emergency contraception.

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  • It seems that making an agency that regulates an enormous proportion of the US economy less accountable to voters (via elected officials) is a terrible idea.

    Already industry often times has to deal with moving targets: what FDA agrees to in the design stage and what the entire new team due to FDA turnover accepts is sometimes totally different.

  • You saved the really bad news for the very end of this piece. Big pharma’s influence on FDA–on full view as we learn the history of the opioid plague–is probably at least as toxic as intra-governmental interference. Probably worse.

  • –I suggest an entirely different approach; a separation of FDA’s drug regulatory functions from current efforts to innovate for Faster Cures; a reformation of the FDA to be a healthcare version of the SEC responsible for regulating against bad actors and maintaining its’ drug approval role.

    However, I would also suggest the formation of a new agency, the National Healthcare Innovation Agency; FDA’s current mission is confounded; I would suggest a healthcare agency similar to the Department of Commerce dedicated to helping particularly startup or relatively new healthcare concerns to navigate through a thicket of federal regulation and also to find and foster opportunities for public/private partnership within various federal and even state agencies (e.g.-NCATS, DARPA, etc.). This is particularly vital for the fostering of new pharma, those firms focused upon neglected and orphan disease, a field which appears to be distinct from big Pharma.

  • The recommendation to free FDA from HHS to avoid political manipulation is naive. Look at the history of AHRQ and subsequent attempts to independence. Congress just decimates the budgets of annoying agencies. Somebody has to be in charge, and that person is appointed or “fired” to use Trumpinology.

    No question that FDA has become too political; CDC is even worse. One way to cede some independence would be to put them on a 5-year appropriation cycle mid-term presidential elections so their budget always comes up across 2 terms.

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