Allergan files suit over off-label talk

November 1, 2009

Allergan is asking a federal judge to permit the company to talk freely with physicians regarding off-label use of Botox.

Irvine, CA-Allergan Inc. is asking a federal judge to allow the company to talk freely with physicians about off-label therapeutic uses of onabotulinumtoxinA (Botox).

The company has filed a federal lawsuit in the U.S. District Court for the District of Columbia, charging that FDA rules prohibiting a company from offering unsolicited information about off-label use of a drug violate the First Amendment.

In an Oct. 2 conference call with investment analysts, Ingram said that physicians have long been permitted to use drugs off-label but pharmaceutical companies can only provide information such as patient selection criteria, dose, and injection technique if physicians specifically ask.

"We . . . believe that allowing physicians to use drugs off-label but at the same time prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risk and benefits and techniques for off-label uses does not serve the public health or patient care," he said.

The issue took on particular significance, Ingram said, when Allergan became subject to the FDA's Risk Evaluation and Mitigation Strategies (REMS) program in September. The REMS program requires, among other things, that Allergan speak in general terms about certain off-label uses of onabotulinumtoxinA. Ingram said the company is unable to comply fully without the ability to provide comprehensive information to physicians without fear of prosecution.

"Allergan's goal, and the goal of this suit, is to be able to speak truthfully about [onabotulinumtoxinA] with physicians and proactively provide accurate and important information about off-label uses of our drug," Ingram continued. "Moreover, we hope this suit will lead to how Allergan can provide relevant and current information on the full range of issues physicians should consider (in order) to determine the best therapies for their patients."

FDA spokeswoman Meghan Scott said the FDA would not comment on pending litigation.

Several analysts on the call questioned what information the company could offer that physicians wouldn't already have through their own research, or who would approve the dissemination of "truthful" information about these off-label uses.

Ingram stressed that the action has no connection with a pending investigation into marketing practices of the onabotulinumtoxinA, and said the lawsuit should have no impact on sales.

"The ultimate goal is to have physicians understand the drug best; restricting information doesn't get you there. Providing more information, not less, gets at that," he said.

David E.I. Pyott, chairman of the board and chief executive officer, Allergan, said the company hopes to learn more specifically how it can comply with the government's regulations in light of the REMS program.

"Let me be . . . clear. We're not looking for flexibility, we're looking for regulation," Pyott said. "We want to know what exactly is permitted so we can follow the rules as laid out by the government."

Although the lawsuit frames the question as a constitutionality battle, Ingram said he is equally concerned about the law's impact on public health.

Toll on public health

"It may very well be the case, I suppose, that your physician has done all the right research and knows of all the possible treatment choices and that he or she has gotten the 800 number from all of the companies that sell all of those drugs, and he or she has called that number and gotten all the right information by asking all the right specific questions so that when you sit down, you can make an intelligent decision. And he or she has gotten all the right information by asking all the right, specific question. I suppose that's a possibility, but it isn't a likelihood," Ingram said.

"The fact is, without the ability to provide that information proactively, the amount of information that physicians will have and the treatment choices they make as a result of it will be mixed at best," he concluded. "A better public health policy answer is that, when information is truthful and accurate and complete, companies ought to be allowed to provide that to all physicians proactively so that, when you or your loved one go into the physician's office, you have the highest likelihood of making informed decisions about various treatment choices."