WWJD -- What Would Janet Do?

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  • 06/09/2015

What does the FDA think of Amarin's plan for off-label communication?

Here's the letter the agency sent them. And, from the pages of the Wall Street Journal,the latest on Amarin's lawsuit and the FDA's counter-strategy.

FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info

By Ed Silverman

Last month, a small drug maker called Amarin AMRN -4.82% caused a stir by filing a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment.

Now, in an unusual move that appears designed to blunt the impact of the lawsuit, the FDA has written a letter to Amarin saying the types of materials the drug maker would like to distribute to doctors actually would not be a problem. And the FDA suggests that Amarin might have known this if the drug maker had discussed the issue before filing its lawsuit.

The lawsuit is being closely watched for its potential to determine whether the FDA can prohibit drug makers from distributing off-label information. The issue has been widely debated after a federal appeals court in 2012 overturned a criminal conviction of a sales rep for promoting off-label uses. The court ruled his speech was protected, since the information was truthful and not misleading.

As we reported previously, Amarin wants to be able to provide doctors with information that does not directly pertain to the approved uses of its Vascepa prescription fish-oil pill. The FDA endorsed the drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.

But two months ago, the FDA rejected an Amarin bid to market its pill to patients with slightly lower triglyceride levels and denied its plan to add effectiveness data to the Vascepa product labeling. Amarin then filed its lawsuit, arguing it has a constitutional right to distribute the information, even though such a move would be considered by the FDA to be off-label promotion.

In its lawsuit, Amarin included a list of medical journal articles it would like to distribute to physicians. However, the FDA writes that none of these are problematic. The agency “does not have concerns with much of the information you proposed to communicate” and the FDA “would not consider the dissemination of most of that information to be false or misleading,” the FDA letter to Amarin states.

As it turns out, the FDA says that Amarin never approached the agency about the issue. In her letter, FDA official Janet Woodcock makes a point of writing that Amarin “did not ask for our views before filing” its lawsuit “as other pharmaceutical companies sometimes do.” A spokesman for Amarin says  the drug maker would not comment.

Moreover, Woodcock also reiterated FDA plans to release a so-called industry guidance for governing the dissemination of off-label information. In effect, the letter amounted to a pre-emptive move that might slow the progress of the lawsuit, according to regulatory experts.

“I think Amarin is frustrated by the results of its dealings with FDA and has resorted to the courts instead of trying to maintain a constructive dialog with FDA,” says Ira Loss, senior health care analyst at Washington Analysis, a consulting firm. “Woodcock’s letter undercuts their case. Not talking to FDA before filing the suit will likely result in a summary judgment for the agency.”

Adds Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry: “Amarin got some bad regulatory advice. The FDA has loudly signaled that it is going to act with increased regulatory discretion on off-label communications. This was either missed or ignored by Amarin.

“… A meeting with the agency would have addressed their concerns. [As for the FDA], “exercising regulatory discretion is a smart move as it takes the matter out of the hands of a judge. A free speech ruling would make things much more difficult for the agency. The FDA opted for strategic retreat rather than face a potential sledgehammer legal decision.”


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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