April 15, 2025
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.
April 10, 2025
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.