A decades-old prohibition on drug companies promoting unapproved uses of their products may be eroding, advocates warn.
Promotion of an unapproved use has been a thorny issue in the pharmaceutical world for years. Physicians routinely prescribe drugs for uses that are not on the government-cleared label, but companies are not allowed to promote such uses to doctors.
That might soon change after a small drug company scored a legal victory against the Food and Drug Administration on Friday. A federal court granted a preliminary injunction that would allow Amarin Pharma to promote an unapproved use for its fish oil drug Vascepa.
This ruling, and a similar one back in 2012, applies only to promotion for physicians and not directly to consumers.
At the heart of the argument is whether Amarin can distribute materials that aren’t false or misleading to doctors. Amarin wants to give doctors materials such as clinical trial results and a medical journal article on an unapproved use associated with Vascepa involving certain patients with potential heart problems.
The government says that is a violation of federal law.
Amarin sued the FDA, charging that the prohibition restricts the company’s freedom of speech. A New York judge agreed and granted the preliminary injunction.
An important distinction is that any promotion has to be truthful and not misleading. If the company lies, then the FDA can go after them.
The ruling is similar to another decision in 2012 in the case U.S. vs. Caronia. That case also found that restricting off-label promotion was an attack on freedom of speech, said David Gibbons, an attorney with the firm Hyman, Phelps & McNamara.
The latest ruling alarmed patient advocates who believe it could eventually roll back regulations that shield Americans from unsafe drugs.
It threatens to “strike at the heart of the U.S. regulatory process for ensuring that prescription drugs are safe and effective for their marketed uses,” said Dr. Michael Carome, director of the Health Research Group for the advocacy organization Public Citizen.
Gibbons said the decision could lead to physicians becoming more informed about how a drug works, and other uses that may benefit patients.
“To the extent that physicians are getting better information it could influence what happens at the patient level,” he said.
The pharmaceutical industry believes that the court decision will lead the agency to “expedite review of its promotional policies to align them with First Amendment principles,” reads a statement from an industry coalition called the Medical Information Working Group.
Gibbons cautioned that, as of now, the FDA’s regulation stays in effect. The 2012 Caronia decision was just in the Second Circuit Court of Appeals and other circuits haven’t ruled yet on it.
“There is considerable uncertainty as to how sister circuits would rule if faced with the same set of facts,” Gibbons wrote in a recent blog post.
The Amarin lawsuit also will move forward, and the FDA can appeal the preliminary injunction. The agency did not return a request for comment on whether it intends to do so.
