Newspaper article International New York Times

Deal Allows Marketing of Drugs for Off-Label Use

Newspaper article International New York Times

Deal Allows Marketing of Drugs for Off-Label Use

Article excerpt

The Food and Drug Administration will now allow Amarin to sell Vascepa, an omega-3 fatty acid, for both high and low triglyceride levels.

In a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.

The agreement settles a legal case between the agency and the company, Amarin, a small drug maker that sued the F.D.A. last year for the right to promote its only product, Vascepa, to a broader range of patients. In August, a federal district judge in Manhattan ruled that the F.D.A. could not prohibit Amarin from using truthful information to promote its drug, even for unapproved uses, because doing so would violate the company's right to free speech.

The final settlement is still subject to approval by the court.

On Tuesday, the agency played down the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off- label uses had not changed.

But some legal and drug-safety experts said the settlement could encourage other companies to seek similar arrangements and, ultimately, have profound implications for how drug makers sell their products.

"This really sends a signal to other companies that if you want to engage in off-label promotion, you can negotiate with the F.D.A.," said Dr. Michael Carome, director of health research at Public Citizen, a consumer group in Washington. "Ultimately, that's taking us down a dangerous pathway."

While doctors may prescribe drugs in nearly any way they see fit, the F.D.A. has long argued that drug makers cannot promote their products for unapproved uses. Pharmaceutical companies have paid billions of dollars in fines in recent years after being accused of marketing drugs for off-label uses. …

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