Botox maker challenges FDA ban on off-label marketing

By The Associated Press

NEW YORK — 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 Oct. 1 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 the 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.

“Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment,” Allergan spokeswoman Caroline Van Hove said in a statement.

Drug developers often walk a tight line with off-label drug practices and getting caught on the wrong side can be expensive. New York-based Pfizer Inc. paid a $2.3 billion settlement last month over allegations it marketed drugs for off-label use.

Part of the logic behind the FDA rule is this: the agency has reviewed detailed clinical trial data, spanning years, before approving a drug’s use for a specific purpose. That same level of scientific, controlled review has not gone into unapproved uses.

In a statement Oct. 1, Allergan said some of Botox’s off-label uses are medically accepted and commonly prescribed.

“Once a drug is approved, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses,” the company said, estimating that about 20% of Botox use is off-label.

The ban on off-label marketing to doctors is particularly difficult for Allergan, the company said, since the FDA has required safety updates to Botox’s label.

In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

In general, the new labeling urges physicians to tell patients about the risks of botulin-based drugs and to seek medical care if they develop any symptoms.

“To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique,” the company said. “Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution.”

The Irvine, Calif., company stressed that the lawsuit doesn’t challenge the government’s ability to prohibit pharmaceutical companies from lying or distributing misleading information. Rather, the company said, it seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox.

Allergan is represented in its lawsuit by Paul D. Clement, a partner at King & Spalding LLP in Washington, D.C., and formerly the solicitor general of the United States.