The Tidmarsh Turmoil: Not An Epilogue, By Any Stretch -- Just The End of Act I; Two More To Go... At [Trumpian/Kennedy-Driven] FDA.

To be certain, the level of disruption -- of the core functioning, of a robust pharma-, biotech and life sciences industry in the US. . . is staggering.

Tangerine 2.0 may think his intentional federal regulatory chaos [in, for example big oil, or dirty coal] lets industry "run wild" -- but not so, in pharma. These players have been around for half-centuries -- avoiding company killing litigation over bad drugs -- largely because they take the long view: they don't want hastily green-lit drugs on the market.

This is so, because the US plaintiffs' lawyers will always come back around, with class-loads of injured people from bad drugs. And so ends the hasty, low ethical standards companies [like legacy Schering-Plough, and Purdue Pharma]. So we will file an update, on the literally unprecedented Prasad / Tidmarsh / Wang insanity (at an agency charged with protecting human health, from bad providers) this quiet warm sunny Sunday morn'. . . .

Here's the update -- from across the pond -- at The Guardian [UK]:

. . .Before the job was filled by Pazdur, one CDER employee told the Guardian that “I would never take it” because the position would be a “career killer” in the turnover and tumult at the agency.

“Plus, I’d have Vinay Prasad bitching at me or about me non-stop,” said the employee, who asked for anonymity to protect their job.

After Tidmarsh’s departure, several longtime employees said they were not interested in the position, and Sara Brenner, principal deputy commissioner at the FDA, sent an email on Friday to some CDER employees asking whether any of them wanted to apply.

“The whole process of appointments at FDA in the current administration has been an enormous departure from accepted practices,” Lurie said. “The degree of upheaval at the agency is really difficult to overestimate and leaves people in the agency disconcerted. . . .”

There is a core belief in the industry -- and among the public -- that FDA review is valuable in order to maintain trust and safety. “Predictability from day to day is really what they want, and otherwise, everything is in upheaval,” Lurie said.

The FDA has developed careful and relatively uncontroversial processes over the decades for evaluating drugs, biologics and medical devices.

“But now, everything is up for grabs,” Lurie said. “Suddenly, we have people who can get their drug reviewed in a one-day meeting. . . .”

Chaos is. . . as chaos. . . does. There is zero chance that this nonsense will ever be good for US leadership, in the pharma-, biotech and life sciences sectors. None. Damn.

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