Vanda Pharmaceuticals Inc. et al v. Food and Drug Administration et al
Case Number:
4:25-cv-01648
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Companies
Government Agencies
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April 15, 2025
FDA Drug Rules Under Fire in Pharma Free Speech Fight
Vanda Pharmaceuticals says it spent years establishing that one of its flagship, FDA-approved products is an effective and safe treatment for jet lag. But after being denied agency approval for that use, the company launched a novel First Amendment challenge meant to dismantle federal rules for “off-label” drug promotion.
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April 10, 2025
Vanda Sues FDA To Block Off-Label Use Drug Promo Regs
A pharmaceutical company, a Texas physician and an often-jet lagged traveler sued the U.S. Food and Drug Administration in Texas federal court Wednesday seeking to block marketing restrictions on the off-label uses of FDA-approved drugs, arguing that long-standing rules and Biden-era guidance runs afoul of the First Amendment.