Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have cool breezes and clear blue skies greeting us today. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is pistachio creme, one of several new delights we recently procured before tariffs were imposed. Please feel free to join us. Remember, no prescription is required. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please keep in touch. We have adjusted our settings to accept postcards and telegrams. …
The unexpected move to place George Tidmarsh, the top drug regulator at the U.S. Food and Drug Administration, on administrative leave was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months, STAT explains. In interviews, observers characterized the spate of dismissals, policy reversals, and controversies in all kinds of ways: Soap opera. Unpredictable. In total disarray. And, potentially, unprincipled. From the outside, experienced FDA watchers see a combination of real and important ethical and scientific questions and tawdry details that risk discrediting the agency, and could also put the health of Americans at risk. With the current iteration of the FDA, leaders have thrown caution to the wind, opining about specific products and airing out dirty laundry in public.
Meanwhile, on the day that Tidmarsh resigned amid an investigation into his conduct, he also faced an explosive lawsuit that includes a series of incendiary texts and emails he is said to have sent to a former business associate, STAT tells us. Tidmarsh, who led the FDA’s Center for Drug Evaluation and Research, stepped down Sunday after being placed on leave. At the same time, however, a lawsuit was filed against him in federal court by Aurinia Pharmaceuticals, alleging he defamed the company and had used his perch to advance a “longstanding personal vendetta” against Kevin Tang, once a Tidmarsh business partner and currently chairman of Aurinia. The lawsuit includes records of emails and texts between Tidmarsh, Tang, and Tang’s associates, including one in which Tidmarsh sent Tang a page about narcissistic personality disorder and told him he was “suffering” from it. Tidmarsh denied wrongdoing.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
Leave a Reply