Drugmaker Claims Off-Label Marketing Restrictions Violate Free Speech
As a follow-up to last week's post about GlaxoSmithKline's new CME standards, it appears that some pharmaceuticals companies are not so keen on self-regulation. Allergan Inc., the company that produces the Botox wrinkle treatment, has filed a lawsuit against the Food and Drug Administration (FDA) claiming that the FDA prohibitions on off-label marketing violate the company's right to freedom of speech.
The lawsuit, which was filed last Thursday in the District of Columbia federal court, names the FDA and U.S. Government as defendants. In the suit, Allergan claims that it should be able to educate physicians about the risks and benefits of using Botox treatments for unapproved uses. While physicians may legally prescribe drugs for uses that are not approved by the FDA, drugmakers are forbidden from actively marketing "off-label" uses or encouraging physicians to prescribe them for such.
Botox is approved by the FDA to smooth wrinkles, as well as treat some kinds of muscle disorders. But last April, government officials warned health care providers and patients about potential deadly risks for unapproved uses, such as treating muscle spasms. Specifically, the drugs carried a risk of botulism symptoms, especially when given to children to help alleviate muscle spasms. The warnings resulted in updates to Botox's "black box" packaging label, which now urges physicians to tell patients about the risks associated with botulin-based drugs.
After the jump - how viable are Allergan's claims?
Some common off-label uses for Botox include treating migraines, muscle pains, and junior cerebral palsy. Combined with approved uses, Botox prescriptions generate about $1.3 billion in sales annually for Allergan.
According to company spokespersons, the lawsuit is not an attempt to weaken the government's ability to prohibit drug companies from lying to health care providers or distributing misleading information. Instead, the company urges, drugmakers should be allowed to provide the medical community with truthful information about off-label uses and help boost physician awareness about how drugs can help their patients.
Allergan filed a motion for preliminary injunction on Oct. 1 to enjoin the government from applying provisions of the Food, Drug and Cosmetic Act and FDA regulations that restrict off-label marketing. A complaint filed the same day requests a declaratory judgment setting out that the restrictions, as applied to Botox, are an unconstitutional violation of its First Amendment rights.
It is a basic constitutional law tenet that commercial speech, which proposes a commercial transaction, does not garner the full protection of non-commercial speech. Further, off-label marketing laws are generally justified by the fact that many non-FDA approved drug uses carry greater risk of adverse side effects. For example, drugmaker Eli Lilly marketed its anti-psychotic drug Zyprexa to pediatricians, claiming that the drug's "calming" qualities would help treat attention deficit disorder in children. However, one of the side effects of such pediatric use was severe weight gain and diabetes.
Given the lesser protections given to commercial speech, and generally wariness about off-label marketing in light of the Pfizer and Eli Lilly settlements, Allergan certainly faces an uphill battle in court.
