Botox Maker Sues FDA, Challenging Off-Label Marketing Rules
Seriously. Allergan, Botox’s maker, yesterday sued the FDA in federal court in Washington, D.C., asserting that off-label marketing rules which prohibit drug makers from marketing drugs for unapproved uses violate the company’s First Amendment rights. That’s a novel argument and it’ll be interesting to see how the court sorts it out.
Allergan told Reuters that the lawsuit is not connected in anyway to a criminal probe of the company over, wait for it, accusations of off-label marketing of Botox. And the moon is made of blue cheese.
I hope the court kicks Allergan’s suit to the curb because if it finds in the company’s favor, it would open the door to some epic problems and truly weird advertising campaigns. Even under current rules, off-label marketing has caused a lot of damage to patients (Zyprexa being perhaps the prime example) and it seems appropriate to have some kind of restrictions on the marketing of drugs that can be quite dangerous in some instances.
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