The FDA's self-fulfilling prophecy trap

Top Trump administration health officials came into office alleging that the Food and Drug Administration 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.

• One of the recurring criticisms of the agency is that its decision-making has been inconsistent.
• "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 Wall Street Journal 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.