FDA and Amarin reach deal allowing the company endorse drug for off-Label use
The Food and Drug Administration (FDA) has allowed Amarin Corporation to endorse a drug for off-label use, said the company in a statement on Tuesday. The drug by the New Jersey headquartered drug-maker will be promoted for a use that the federal agency has not allowed yet.
The new deal will resolve a conflict between FDA and the company that last year went to court against the federal agency for its product, Vascepa. Amarin claimed that it has the right to promote a drug that can help many people. In August, a Manhattan judge ordered the FDA not to stop the drug-maker from promoting truthful information on the drug.
Now, the FDA and the biopharmaceutical company have agreed on a deal and eying on the court to approve it.
The deal is applied only to the company’s this case, but its view on right to provide truthful information about off-label uses is still the same, said Amarin in a statement on Tuesday. Some experts are not happy with the settlement. They said it could encourage other drug-makers in the country to look for similar arrangements, which may violate how companies promote their drugs.
“This really sends a signal to other companies that if you want to engage in off-label promotion, you can negotiate with the FDA. Ultimately, that’s taking us down a dangerous pathway”, said Dr. Michael Carome director of health research at Public Citizen.
Doctors are allowed to prescribe drugs to patients in any way they see beneficial. But FDA thinks biopharmaceutical companies should not be allowed to endorse their drugs for unapproved uses. In past, many drug-makers have paid fines for promoting drugs for off-label uses. The pharmaceutical industry claims medical companies should be allowed to share information about its products.