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To what extent should drug makers be allowed to convey information about unapproved uses for their medicines?
The question has been widely debated after a federal appeals court three years ago overturned the criminal conviction of a sales rep for promoting so-called off-label uses of a drug. The court ruled his actions constituted protected speech, since the information was truthful and not misleading.
The FDA did not challenge the decision. And since then, the pharmaceutical industry has been lobbying the agency to revise its guidelines, because the ruling only applied to three states. The FDA has not indicated when it will take action, but plans to hold a meeting this summer to review the contentious topic.
Now, one drug maker is trying to force the issue. Amarin AMRN -6.57% yesterday filed alawsuit hoping to convince a federal court that the FDA prohibition on off-label promotion violates the company’s First Amendment rights, and that its reps should be able to convey truthful and “non-misleading” information to doctors.
“It’s important the FDA does not have the power to stifle speech,” says Floyd Abrams, a constitutional lawyer who represents Amarin. “And FDA is effectively stifling speech, unless we get a firm ruling from a court, which is very important to ensure the public is well served.”
Amarin took action after growing frustrated with an FDA decision about its Vascepa prescription fish-oil pill. The medicine is approved to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease, but Amarin sought to sell the drug to people with lower levels.
Last month, the agency rejected its request, after determining there was no evidence Vascepa lowered the risk of cardiovascular disease. The FDA also decided Amarin could not include trial data in Vascepa labeling about the extent to which the pill may effectively treat people with slightly lower levels of triglycerides. Safety data from the trial, however, is in the labeling.
Joel Kurtzberg, an attorney representing Amarin, says the drug maker simply wants to provide data to doctors, some of whom prescribe Vascepa off-label. In general, off-label prescribing accounts for as much as 20% of all prescriptions, according to the American Medical Association.
As far as Amarin is concerned, it now “finds itself in a bind,” according to its lawsuit in federal court in New York. The drug maker “may not freely communicate truthful and non-misleading information about Vascepa to health care professionals…without fear of criminal prosecution and civil liability.”
“This is a very big deal,” says Ira Loss, senior health care analyst at Washington Analysis, a consulting firm. “If the court rules they can disseminate information as they would like to do so, It would open things up for much more promotional activity of pharmaceutical products.”
To what extent Amarin will be successful remains unclear. But the case is going to be very closely watched because it has the potential to dramatically shift the way the pharmaceutical industry markets medicines and interacts with physicians.
This “could bring to head a lot of the issues we’ve all been talking about for a number of years,” says Alan Bennett, a lawyer who represents the Medical Information Working Group, several drug makers that petitioned the FDA to move faster to issue new guidelines about conveying off-label information.
But some worry a ruling that favors Amarin will weaken protections for patients. “This will undermine the drug approval process and allow companies to bypass the FDA,” says Michael Carome, who heads Public Citizen Research Group. “There would be no incentive to seek FDA approval for new uses.”
The lawsuit, meanwhile, adds pressure on the FDA to move faster to issue guidelines. “It’s always better for the agency to control the pace,” says Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry.