As the U.S. government cracks down on advertising off-label uses of drugs, one company is fighting back. Allergan Inc., which makes the drug Botox, has filed a legal action against the government, seeking the right to "share truthful, relevant information" with physicians about off-label therapeutic uses of its drugs.
Off-label use of approved drugs by doctors is not illegal. But a drug company isn't supposed to push off-label uses. In its complaint, the Irvine, Calif., drug company contends that the government's legal position -- that it's a crime for a drug company to 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 complaint filed Thursday names the United States; the Food & Drug Administration as well as its commissioner, Margaret Hamburg; and Kathleen Sebelius, secretary of Health & Human Services, as defendants. If successful, the action could have broad implications for all drug companies.
Charles Miller, spokesman for the Justice Department's civil division, says, "Unfortunately, we have nothing we can provide in regard to this lawsuit at this juncture."
Douglas Ingram, Allergan's chief of global legal affairs, says about 20 percent of all prescriptions in the U.S. are for off-label uses of drugs. Ingram says Botox -- not to be confused with its sister drug, Botox Cosmetic -- is approved to treat certain types of spasms involving the eye.
Yet some off-label uses of Botox are medically accepted and commonly prescribed, he says, such as to help relieve adult spasticity after strokes or juvenile spasticity due to cerebral palsy. But it could take 10 years for Allergan to complete the clinical trials necessary to win FDA approval for these uses, he adds.
Allergan's complaint claims the FDA "has promulgated a series of overlapping and interlocking regulations that combine to render unlawful virtually all manufacturer communication, through any avenue, to any audience, about the lawful off-label use of a prescription drug."
Ingram stresses that Allergan is not trying to interfere with the government's right to stop companies from disseminating false or misleading information about products. But he says his company simply wants to be able to assist physicians in evaluating the benefits and risks of off-label uses of Botox to treat patients suffering from serious, debilitating conditions.
"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," Ingram adds. By banning such speech, the FDA's actions "don't serve public health and aren't good for patient care."
Allergan's action, filed in U.S. District Court for the District of Columbia, seeks a declaratory judgment against the government. It also asks for a preliminary injunction to halt government enforcement that is "currently causing irreparable harm to Allergan's First Amendment rights by chilling Allergan's protected speech."
Allergan is represented by Paul Clement, a partner at King & Spalding in Washington, and a former U.S. solicitor general.
[Editor's Note: Botox and Botox Cosmetic are registered trademarks]