Ruling Lets Drugmaker Promote Use Without FDA Approval

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Amarin Corp. won a court ruling allowing the company to give doctors information about unapproved uses of its fish-oil pill, despite the objections of U.S. regulators seeking to limit how drugmakers promote their products.

The ruling by a federal judge could open the door for the pharmaceutical industry to more openly encourage doctors to try its medications for uses the Food and Drug Administration hasn’t approved. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses.

Amarin’s prescription-grade omega-3 fatty acid is approved to treat severely high triglycerides -- a measure of fat in the blood. The company wanted to provide doctors information on a trial that examined the drug’s use in patients with more moderately elevated triglycerides. It said the FDA threatened to bring misbranding charges against the company if it tried to discuss that off-label use.

Amarin claimed the FDA was “chilling it from engaging in constitutionally protected truthful speech,” according to the ruling filed Friday. Judge Paul Englemayer of the Southern District of New York agreed, saying Amarin can talk truthfully to doctors about treating patients with triglyceride levels that aren’t as high as the FDA has mandated.

More Handouts

The decision means the FDA needs to more broadly apply a 2012 ruling overturning a criminal conviction of a sales representative for promoting an off-label drug, said Richard Samp, chief counsel at the Washington Legal Foundation. That case was United States v. Caronia.

“It’s a huge victory,” said Samp, whose law and policy center advocates against government interference in business. “The Caronia decision provides absolute First Amendment protection about truthful speech.”

Sarah Peddicord, an FDA spokeswoman, declined to comment on the ruling, which remains in effect until another trial can be heard.

Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The ruling allows pharmaceutical companies to hand out the information more widely without a request.

The ruling may allow companies to do direct-to-consumer advertising for unapproved uses, though it’s unlikely they would do that, Samp said.

Better Decisions

“It would be so much easier for FDA to argue that consumers might potentially be misled by a DTC than a doctor because presumably doctors are experts that will know the truth of things that were left unsaid,” he said.

Amarin’s American depositary receipts rose 12 percent to $2.28 at 2:09 p.m. in New York, after climbing as much as 27 percent in the biggest intraday gain since May 28.

“This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients,” John Thero, president and chief executive officer of Dublin-based Amarin, said in a statement.

About 20 percent of all prescriptions in the U.S. are for off-label use, the company said.

The FDA wrote Amarin in June and agreed the company could make some claims about off-label use, though the agency objected to the company’s statement that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

New Sentence

The FDA said the claim could cause doctors to prescribe the pill in lieu of promoting a healthy lifestyle and taking a cholesterol-lowering statin drug, the court document said.

Amarin argued it should be able to make “truthful and non-misleading” statements. The court agreed that such statements shouldn’t be considered misbranding.

Amarin said it would add a sentence to the coronary heart disease claim that Vascepa shouldn’t be taken in place of a health lifestyle or statin drug.

The FDA rejected expanding Vascepa’s use to people with elevated triglycerides in April and said Amarin needed to complete a study on the drug’s ability to benefit the heart before an approval decision could be made. The FDA had previously agreed that a cardiovascular study wouldn’t be needed before approval, though that was before studies on other drugs failed to show a heart benefit from lowering triglycerides.

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