Something fishy in the off-label conversation

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  • 05/08/2015

Unless the FDA takes control of the off-label conversation firmly and swiftly. Things are not going to be pretty.

Case in point -– a company jumping on the off-label bandwagon because of an FDA decision they didn’t like? Dangerous times.

Here’s the brief from the Wall Street Journal:

Drug firms challenge FDA over free speech

To what extent should drug makers be allowed to distribute 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.

Since then, the pharmaceutical industry has been lobbying the FDA to revise its guidelines, because the decision only applied to three states. The agency hasn't indicated when it will take action, but plans to hold a meeting this summer to review the topic.

Now, one drug maker is trying to force the issue. Amarin Corp. on Thursday filed a lawsuit 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,” said 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.

Late last month, the agency rejected that request and also decided Amarin couldn't include clinical trial data in Vascepa labeling about the extent to which the pill may effectively treat people with slightly lower levels of triglycerides. Data from the trial is in the labeling.

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 nonmisleading information about Vascepa to health-care professionals…without fear of criminal prosecution and civil liability.”


“This is a very big deal,” said 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 a head a lot of the issues we’ve all been talking about for a number of years,” said 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,” said 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,” said Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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