Botox v. United States

Maybe Botox maker Allergan Inc. didn't get the memo.

Just one month after the government made an example of Pfizer Inc. over the promotion of drugs for unapproved uses, Allergan is suing the feds saying that its First Amendment rights are being trampled.

For years doctors, prescribed medicines for all sorts of things. It's not illegal for the docs to do so, but it is unlawful for drug makers to encourage the practice. Allergan wants to let doctors know about ways Botox can help people beside getting rid of their wrinkles. For instance, the company is seeking approval for Botox use for migraine headaches.

The government made a strong statement when it announced that Pfizer would pay $2.3 billion and agree to never push doctors to prescribe medicines for uses that are not approved by the Food and Drug Administration. The federal fraud settlement was the largest ever for any health care company.

Now Allergan is testing the system, saying that it has every right to do just what Pfizer got slapped for doing. The Irvine, California-based company filed suit in U.S. District Court for the District of Columbia this week, saying its free speech rights are being violated.

A First Amendment lawyer says the company may have a decent argument and he wouldn't be surprised if the suit makes it all the way to the Supreme Court.

"They have a good case but I also think the federal court will lean over backward to defend a food and drug regulatory system that's been in place for over a century," says Bruce E.H. Johnson, a partner with Davis Wright Tremaine LLP in Seattle. "This is one that could very easily go to the Supreme Court. If the court system believes that the federal government is over-regulating commercial speech it will act."

Allergan stresses that it has no intention of telling doctors anything misleading about potential uses of Botox or any of its drugs. Therefore, it has the right to promote its products.

"We believe that the inability to share such important information proactively with the medical community violates the First Amendment and potentially diminishes the quality of patient care," Douglas S. Ingram, Allergan's chief administrative officer and secretary, says in a statement.