Hello, everyone, and how are you today? We are just fine, thank you, now that the Pharmalot campus settled down. The shortest person is off and running to her summer job and the official mascots are now quietly snoozing in their respective corners. As for us, we are quaffing more cups of stimulation, which reports indicate is a good idea, and invite you to join us, as always. Meanwhile, here are some items of interest. Hope you conquer the world today …
The Food and Drug Administration wants to institute rigorous new safety standards for how immediate-release opioids are prescribed, The Wall Street Journal reports. The agency plans to require drug makers to make available expanded training for doctors, nurses, and other health-care professionals who administer the immediate-release medicines. The approach would expand existing safety measures already required on extended-release pain drugs.
The FDA reversed a decision and will now consider approving migalastat, a Fabry disease treatment developed by Amicus Therapeutics, STAT tells us. Initially, the FDA wanted Amicus to collect more data, which was expected to take until 2019 or 2020. Amicus CEO John Crowley says the company convinced the FDA to look at its data using new analyses, including some that had been requested by regulators in Europe, where the drug is approved.
Early in my career the FDA pounded the phrase “It is not our job to regulate the practice of medicine”. They have strayed mightily with this new opioid practice guideline, which while well intended, is for all practical purposes unenforceable.
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