Hello, everyone, and how are you today? We are doing just fine, thank you, helped along by a shiny sun enveloping the quiet Pharmalot campus. We are back to our usual routine after ducking out for a talk yesterday and happily ensconced with a cup of stimulation in hand. As always, we invite you to join us. Meanwhile, here are some tidbits as you get ready to watch the FDA confirmation hearing. Hope you have a smashing day and do keep in touch …
Representatives from the biotech, device, and generic drug industries told a Senate committee that if the five-year user fee programs are not reauthorized, the FDA would likely see more than 3,000 job cuts, Regulatory Focus reports. The layoffs, which the trade groups worry will slow product reviews and approvals, will occur if Congress and President Trump fail to act before Aug. 1 or the annual congressional summer recess.
If Dr. Gottlieb is confirmed and needs to divest, I hope they at least allow him a capital gains rate for an abrupt cash out. Oh, as for Dr. Price, ‘full price’ for him.
Once Dr. Gottlieb gets in there, eliminates a few layers of management and massively streamlines the review process, those 3000 ex FDAers will not be missed and the drugs will get approved in the same amount of time without the usury (i.e. user) fees.
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