Archive for the ‘botox FDA’ Category

Off-Label Marketing II

Monday, October 5th, 2009

Allergan, Inc. the makers of Botox pulled a switch recently.  The company charges in an unprecedented suit against the FDA that restrictions on promoting Botox  for unapproved uses like spasticity violate the company’s First Amendment rights to speak truthfully to doctors about its drug products! This is a direct challenge to the Government’s right, discussed in the last blog, to restrict illegal drug promotion, and, according to Jeffrey N. Gibbs a lawyer specializing in food and drug law, quoted in the New York Times, “a broad attack on the constitutionality of FDA restrictions on speech by an individual company…They are seeking relief which would invalidate all of the FDA regulations which restrict the promotion of drugs.” The operative adjective here is speak truthfully. 

Botox by injection is approved in the U.S. to treat crossed eyes, eyelid spasms, excessive sweating, wrinkles, neck contortions.  But many doctors use the drug for unapproved indications like facial spasm, vocal cord problems, and migraine. (Serious complications have occurred for these latter uses, including difficulty swallowing, and breathing difficulties.)

Talk about chutzpah, this case beats them all. If by chance this lawsuit is successful, it will result in unimaginably horrendous consequences for drug regulation and for the public health. Free speech indeed vs. “truth in advertising.” Go figure.