Top of the morning to you, and a fine one it is. Clear blue skies are enveloping the Pharmalot campus this morning, where the official mascots are enjoying the tundra-like grounds and we are brewing yet another cup of stimulation. Our choice today, for those who track this sort of thing, is hot buttery rum. As always, you are invited to join us. Meanwhile, we have assembled the latest menu of tidbits for you to peruse as you get started on your journey today. We wish you the best of luck and, of course, do keep in touch. The inbox is open …
The Food and Drug Administration informed senior executives at Merck, Sanofi, and AstraZeneca last week that their approved protective RSV treatments for infants would be subject to fresh safety scrutiny following concerns raised by vaccine skeptics, Reuters reports. The preventive therapies — Beyfortus from Sanofi and AstraZeneca, and Enflonsia from Merck — would be the latest called into question under Health and Human Services Secretary Robert F. Kennedy Jr., a longtime promoter of anti-vaccine views who is presiding over a review of routine childhood immunizations. FDA officials appointed under Kennedy began making inquiries into the respiratory syncytial virus therapies over the summer, according to sources and internal documents. It is unclear whether the FDA will ultimately take any actions to change the product label or restrict availability of the therapies.
The FDA has delayed a promised review of safety data for the abortion drug mifepristone at the request of Commissioner Marty Makary to put it off until after the midterm elections, according to Bloomberg News. Makary and HHS Secretary Robert F. Kennedy Jr. have told lawmakers and state attorneys general for months that they are actively conducting a review of mifepristone. But behind the scenes, Makary has told agency officials to delay the safety review. Pushing the closely watched abortion pill study beyond next year’s midterms has the potential to help minimize the role of abortion in the upcoming elections, in which some Republicans are facing tough battles to hold onto their seats. Abortion restrictions popular with the right-wing base do not necessarily poll well with all voters. A 2024 Pew survey found majorities of moderate or liberal Republicans say abortion should be legal in all or most cases.
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