STAT+: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more

STAT PlusNewsletterPharmalot Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more Louisiana urged the Supreme Court to let stand a ruling blocking access to mailed abortion pills Manage alerts for this article Email this article Share this article By Ed SilvermanMay 8, 2026 Pharmalot Columnist, Senior Writer Ed Silverman[email protected]Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. 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, but will certainly include promenading with the official mascots, catching up on our reading, and taking a nap or two. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The possibilities are endless this time of year, yes? You could enjoy the great outdoors, stream the hours away if the weather fails to cooperate, or rifle through your ever-growing to-do list. Or maybe you simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. And if mom is around somewhere, remember to say hello. See you soon. … A proposal by the U.S. Food and Drug Administration to remove references to “gender” from its regulations sparked concerns about unintended consequences on research on gender minority populations, Bloomberg News explains. The FDA issued its proposed rule this week, citing instructions laid out in a 2025 executive order from President Trump, as the administration emphasizes “biological sex” across federal government policies and practices. The Trump administration has supercharged efforts to signal there are only two biological sexes. The FDA said the policy is unlikely to change much, stating the proposal “does not impact industry practice” and they “do not anticipate any measurable change in industry.” But some legal experts see potential for broader impacts on how drugs are tested or who is represented in clinical trials, especially among groups that are traditionally underrepresented in research.Advertisement Louisiana urged the U.S. Supreme Court to prevent abortion pills from being prescribed through telemedicine and distributed by mail, as the Republican-led state presses its case to overturn a 2023 federal rule that made access to ​the medication easier, Reuters writes. In a filing, Republican Louisiana Attorney General Liz Murrill asked the justices to deny emergency requests by two manufacturers of ‌the abortion pill to lift a lower court’s decision that narrowed access to it by blocking the regulation nationwide while the state’s legal challenge continues. The regulation concerning the medication, called mifepristone, was issued by the FDA during Democrat Joe Biden’s presidency. Murrill’s office said the regulation has allowed medication abortions to skyrocket despite the state’s near-total ban on abortion. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In pharmalittle, STAT+ Submit a correction requestReprints Ed Silverman Pharmalot Columnist, Senior Writer Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. 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