Allergan Suing FDA Over Off-label Policy

DAMIAN J. TROISE

NEW YORK (AP) — Allergan Inc., the maker of the Botox wrinkle treatment, challenged the government's ban on off-label drug marketing to doctors, saying it violates the company's right to freedom of speech.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses.

Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

While physicians can legally prescribe a drug for unapproved uses, companies are forbidden from marketing the product, especially to physicians, for any use not sanctioned by the FDA.

The FDA said it doesn't comment on pending litigation. The lawsuit was filed in U.S. District Court for the District of Columbia against the U.S. government and the FDA.

The catalyst for the lawsuit is a requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment.