Top Trump administration health officials came into office alleging that the FDA failed to follow the best science, operated in secrecy and was too beholden to industry.

• Such accusations have, if anything, become more frequent since then.

Why it matters: Critics say some of the agency's recent actions have put its status as the world's most respected drug regulator at risk — undermining the administration's stated goals and making it less likely that people will have confidence in its future decisions.

• "They made it seem like FDA was a problematic agency that people didn't trust and didn't have confidence in, and that just wasn't the case," said Raymond James analyst Chris Meekins, a health official in the first Trump administration.
• "They've created an environment where there's increased uncertainty that's jeopardizing investment and future innovations for patients."

State of play: There has been a lot of FDA news in recent weeks, particularly around the departure of top drug regulator George Tidmarsh amid corruption charges. Tidmarsh has denied the allegations and blamed a toxic culture at the agency.

• The FDA has also been busy removing the boxed warning from hormone treatments, announcing a new pathway for gene-editing therapies that aim to treat a single patient and beginning the process for approving a new treatment for autism symptoms.
• It also created a new priority review voucher program and reportedly disappointed a couple of biotechs with updated drug approval requirements.

The common thread is nearly all of the actions have been criticized by experts, watchdog groups or even more traditional conservative allies as deviating from established regulatory or scientific processes, possibly at the risk of undermining public trust in the agency.

• "There seems to be an interest in trying to get things done through the least amount of process," said one former FDA official. "All of those things lead to a public perception that the agency is making things up as it goes along."

The FDA has reasons for what it did in the past, and could justifiably be criticized for being being too slow and bureaucratic, said Robert Steinbrook, Health Research Group director at Public Citizen.

• "But the underlying processes of reliance on robust clinical trials, usually more than one, and thoughtful internal and external process ... the very fact that you go through an open, public process of questioning and debate, that leads to better decisions," he said.
• "The general approach of rushing things, of going first through media and op-eds and television before announcements are made, and to not start with the medical, the specific ... that just does not inspire confidence," Steinbrook added.

And inconsistency itself has been blamed for fostering a climate of unpredictability for biotech investors and drug companies.

• A recent WSJ editorial blasted the agency's handling of two rare disease drug candidates and accused it of having "arbitrary and shifting standards."

The other side: "No FDA in history has produced so much regulatory innovation in such a short span, or been as transparent with the public. Axios' corporate-funded slop was not built to keep up with the intellectual rigor that embodies today's FDA," HHS Assistant Secretary for Public Affairs Richard Danker said in a statement to Axios.

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Health Secretary Robert F. Kennedy Jr. was sworn into office after he spent decades questioning FDA's decision-making — particularly on vaccines — and after a now-notorious post on X promising that "FDA's war on public health is about to end."

• FDA commissioner Marty Makary was a well-respected Johns Hopkins surgeon with a contrarian streak who gained attention during the pandemic for regularly bashing the federal response, including on COVID vaccines.
• "If confirmed, I hope to ensure the FDA holds to the gold standard of trusted science, transparency, and common sense to rebuild public trust and Make America Healthy Again," Makary wrote in his opening statement for his confirmation hearing earlier this year.

Between the lines: It's normal for regulatory actions to divide opinions; rarely is any decision universally beloved, and plenty have been loudly criticized. (Remember Aduhelm, the pricey Alzheimer's drug that the FDA fast-tracked and became engulfed in controversy over safety worries and its steep list price?)

• But what stands out is the way the agency is creating the perception it's perpetuating the very problems that it was aiming to fix.
• "There's a disconnect" between leadership's claim to value transparency, gold-standard science and the agency's actions, said Reshma Ramachandran, an assistant professor at the Yale School of Medicine and a board member of Doctors for America.
• "There's an agenda being pushed that is not rooted in science that is compromising the scientific integrity of the agency as a whole," she added.

The other side: "It is easy to criticize change agents — especially leaders whose primary goal is to change the culture of a bureaucracy as complex and set in its ways like FDA," said David Mansdoerfer, a senior HHS official in the first Trump administration.

• "Disrupting the status quo is difficult — and when there are inevitable setbacks, people will try and pile on to try and score their political points," he added.
• Even most critics can find something to praise about the agency, especially this week's elevation of respected agency veteran Richard Pazdur to be the director of the Center for Drug Evaluation and Research.
• In fact, one of the recurring criticisms of the agency is that its decision-making has been inconsistent. Some of the people I spoke to while reporting this newsletter blasted one decision and then went out of their way to bring up something else that they liked.

This week's hormone therapy announcement raised a fresh-but-representative round of complaints.

What happened: The FDA on Monday announced it was taking "bold action on women's health" and getting rid of the highest-level "black box" warning on menopause hormone therapies, which Makary has called "maybe one of the greatest screw-ups of modern medicine."

• The warning was added in 2003 after a federally funded study suggested the treatments increased the risk of breast cancer, stroke and heart disease.
• More recently, doctors and women's health advocates have argued that the study results have been taken out of context, and the treatments could ease the symptoms of menopause.
• The decision was made after an expert panel of doctors handpicked by the FDA over the summer endorsed scrapping the warning.

What they're saying: Even supportive groups nodded toward the unusual process.

• "While we are happy with the decision, we are concerned that the well-established and successful Advisory Committee system, which provides systematic and independent peer review, was not utilized," American Society for Reproductive Medicine CEO Jared Robins said in a statement.

Others were less than thrilled with the outcome.

• "Overblown press conference announcements and unsubstantiated labeling updates do not protect women's health," Public Citizen's Nina Zeldes said in a statement.
• Adriane Fugh-Berman, director of Georgetown University Medical Center's PharmedOut initiative, called the decision a "dangerous distortion of science" and argues that "the agency is now echoing the glowing language once crafted by pharmaceutical marketers."

The bottom line: Restoring public trust in health agencies has been a self-professed top goal of the Trump administration. The FDA may be headed in the opposite direction.