Irvine-based drug maker Allergan Inc. has filed a lawsuit against the federal government to allow it to approach doctors who are using the drug for uses not outlined by the Food and Drug Administration.
The company is challenging the FDA’s “off-label” policy that prohibits drug makers from talking to doctors upfront about prescribing a drug for conditions other than approved uses.
Once a drug is approved by regulators, doctors can prescribe it for any condition they see fit. But Allergan and other drug makers can’t promote drugs for unapproved uses.
Allergan wants to be able to provide doctors with details about dosages, patient conditions and other factors in unapproved cases, the company said. Its medical affairs staff can do so now but only after being asked by doctors.
Botox is approved as a medical cosmetic product to smooth out wrinkles and for other conditions such as treating neck spasms, eye muscle disorders and excessive underarm sweating.
Allergan hopes to get the drug approved as a treatment for migraines, overactive bladders and other conditions.
The company “has a strong commitment to expanding” Botox but isn’t looking to promote new uses of the drug with the lawsuit, spokeswoman Caroline Van Hove said.
“Allergan contends that the government’s legal position that it is a crime for a pharmaceutical company to proactively communicate truthful information to physicians about off-label uses of its products violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act,” the company said in a statement.
Paul D. Clement, a partner at King & Spalding LLP in Washington, D.C. and a former solicitor general, is representing Allergan on the lawsuit.
Botox is company’s biggest selling drug with second-quarter sales of $337 million. The company has overall quarterly sales of about $1 billion.
The drug’s fame as a wrinkle remover came from off-label use by cosmetic doctors who used it for years for treating wrinkles before regulators approved it for that use in 2002.
