Drug firm sues to end off-label marketing ban

One pharmaceutical company is turning to the courts in an effort to force a major change in the way the Food and Drug Administration regulates the marketing of off-label drug uses to physicians.

While some doctors say the case challenging the government's ban on such advertising could jeopardize drug safety if it proves successful, other legal and industry experts suggest that it could facilitate a better flow of information and enhance patient care.

The lawsuit -- filed Oct. 1 by Allergan Inc., maker of the Botox brand of botulinum toxin A -- charges that the FDA's off-label marketing restrictions prevent pharmaceutical companies from sharing truthful, accurate information about their products with physicians. The company claims that the prohibitions violate its constitutional right to free speech, according to the complaint filed in U.S. District Court for the District of Columbia.

The legal action stems from what Allergan says is an inconsistency in FDA policy that allows physicians to legally prescribe drugs for unapproved indications, while at the same time chilling unsolicited communications about such uses from companies to doctors.

Some physicians say the ban has provided an important check on the industry when it comes to products that have not been thoroughly tested.

"It's one thing for physicians to be allowed to prescribe a drug off-label when they themselves have experience with it or read something about it in a medical journal. It's another thing for companies to promote the off-label uses of drugs when the scientific evidence is not there," said Jerome P. Kassirer, MD, a professor of medicine at Tufts University School of Medicine in Massachusetts.

"The difference is, the number of people who could be exposed could be enormous," he said. Dr. Kassirer is also the former editor-in-chief of the New England Journal of Medicine.

New regulation possible

But the case could lead to the creation of clear regulation on the issue at a time when legitimate off-label use is so widespread, said Mark Mansour, an attorney in the FDA practice of Bryan Cave LLP in Washington, D.C., and a partner at the firm.

"There is a sense that the FDA is behind the curve on off-label use, and this lawsuit is an effort to try to force a discussion and find some standards," Mansour said.

The FDA declined to comment, citing the pending litigation.

Allergan Executive Vice President and Chief Administrative Officer Douglas S. Ingram stressed that the lawsuit would not interfere with the government's right to stop companies from disseminating false or misleading information about a drug. But because off-label prescribing is common medical practice, firms should be able to share available research about the benefits and risks of off-label uses to help doctors make fully informed medical decisions, he said.

"If the ultimate goal is to get an accurate view of a drug's uses and quality, the answer is not to restrict that dialogue but to encourage it," he said.

Other information avenues

Physicians have other, less controversial ways to get information about unapproved drug uses from pharmaceutical companies, said Nishendu M. Vasavada, MD, an adjunct faculty member at the Southern Methodist University Simmons School of Education and Human Development in Dallas. For example, doctors can make requests directly to their medical affairs departments, or drugmakers can disseminate data through peer-reviewed journals.

While many medications have been used off-label successfully, the FDA rules were meant to serve as an incentive for drugmakers to do the clinical studies necessary to support such data and gain FDA approval, said Dr. Vasavada, who also serves as a consultant to various drug firms.

The government recently stepped up efforts to crack down on illegal drug marketing, a move that Dr. Vasavada said has helped keep drugmakers in line. Pfizer was the latest to face legal trouble. It settled with the government in September for a record $2.3 billion for alleged illegal off-label promotion. though it denied some of the charges.

But easing the restrictions on legitimate advertising would not mean that the government would be forced to let up its enforcement activities if companies were to misbehave, Mansour said. Doctors may benefit from added legal protections, as well.

Physicians can seek out off-label information on their own, "but they do it at their own risk, and they are still liable for prescribing something for the wrong use," Mansour said. If drug firms "can get this information out on the table, it helps everyone."

The FDA has encountered a similar constitutional challenge to its off-label policies at least once before, according to Michele L. Adelman, a health care regulatory expert with Foley Hoag LLP in Boston.

She cited a 1998 district court ruling that found FDA restrictions at the time on educational -- versus promotional -- materials on off-label use violated drugmakers' rights to commercial free speech. The court agreed that the government had a substantial interest in protecting the public health, but it found that the guidelines were more restrictive than necessary. The case was brought by the Washington Legal Foundation, a public interest law firm that advocates against strict government regulation.

The ruling ultimately was rendered moot by subsequent FDA guidelines that created safe harbors allowing drugmakers to share certain off-label information via medical journals and continuing medical education activities.

Still, "this First Amendment argument has been around and is actually pretty persuasive," Adelman said. "At the bottom of it is the whole concept of preventing truthful speech, which does seem to fly in the face of First Amendment rights."