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STAT+: Pharmalittle: We’re reading about FDA losing key personnel, a ‘colossal’ Pfizer tax dodge, and more
Both deputy directors at the key FDA center that oversees regulation of cancer drugs plan on leaving the agency
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up. We expect to promenade with the official mascots and catch up on our reading, but are, otherwise, open to suggestion. Of course, we do hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Now that spring has sprung, this may be an opportunity to enjoy the great outdoors by enjoying a long walk or taking a ride through pleasant countrysides. Those of you who live on our side of the pond may want to finish your taxes (this thought will not be followed by a political statement). Or perhaps this is a good time to plan a needed getaway. We all need to get away from something once in a while, do we not? Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
Some drugmakers are taking the unusual step of sending more medicines by air to the U.S., two executives and two logistics firms said amid fears President Trump’s April 2 tariffs announcement could include products made in Europe, Reuters reports. Two drugmakers headquartered in Europe say they are sending as much of their medicines across the Atlantic as possible over the past several weeks and heard other drug companies are doing the same. One executive said his company was “scenario planning” for possible tariffs and shipping more medicines by air using global cargo and transport firms including United Parcel Service and DHL. A source at a third international drugmaker said they were quickly moving in available stock from overseas in an effort to get ahead of tariffs, but did not specify shipping method. DHL said it had seen a rise in pharmaceutical exports by air from Europe, but did not give a reason for the increase. UPS declined to comment.
Both deputy directors at the key U.S. Food and Drug Administration center that oversees regulation of cancer drugs plan on leaving the agency, STAT reports. Their departures highlight the drain on FDA talent created by layoffs, uncertainty, and shifts in policy at the agency even as it is set to lay off thousands more people. Both Paul Kluetz, who joined the FDA as a medical reviewer in 2016, and Marc Theoret, who joined as a medical reviewer in 2009, have told colleagues of plans to leave. The FDA Oncology Center of Evidence was created in 2017 by Congress as a way to speed the development of cancer drugs. The OCE is run by Richard Pazdur, an oncologist who has overseen cancer drug approvals at the FDA since 1999 and who became a central figure in the push to approve treatments more quickly through accelerated approval. Investors have been cheered by the fact that FDA layoffs, including 3,500 cuts announced Thursday, appear designed to spare those who review drugs, biologics, and other products. This is likely because those jobs are funded, in part, by user fees paid by companies when they seek approvals.
