Heart and soul, I fell in love with you
Heart and soul, the way a fool would do, madly
Because you held me tight
And stole a kiss in the night
https://justthenews.com/government/federal-agencies/not-just-ivermectin-new-fda-authority-ban-label-uses-alarms-doctors
The authority to ban off-label uses was buried on page 3,542 of the 4,155-page omnibus appropriations bill signed into law at year's end, though it's specifically applied to "banned devices."
The FDA requested this "very unprecedented" update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it's not clear whether the agency could broadly interpret "devices" to cover drug treatments.
Law firm Morrison Foerster specifically credited the revision to a 2021 ruling by the U.S. Court of Appeals for the D.C. Circuit that prohibited the FDA from banning "individual intended usages of an otherwise legally marketed device," in that case "electrical stimulation devices used to treat aggressive or self-injurious behavior."
Oh! but your lips were thrilling, much too thrilling
Never before were mine so strangely willing
But now I see, what one embrace can do
Look at me, it's got me loving you madly
That little kiss you stole
Held all my heart and soul
https://ko-fi.com/thejournaloflingeringsanity