FDA strictly enforces prevention of off-label promotion of products. In the recent past, there have been numerous cases of FDA’s punitive actions against companies and individuals accused of off-label promotion. US courts have repeated sided with FDA in agreeing that off-label promotion is not protected by free speech rights. Now Amarin Corporation, the manufacturer of Vascepa, an FDA approved prescription drug containing Omega 3 fatty acid, has filed a free speech case against FDA to resist restriction imposed by FDA to make off-label claims for Vascepa. The company claims that it is within its rights to promote the general health claims of fish oil and omega 3 fatty acids when marketing Vascepa. Amarin claims that while it is committed to share “non-misleading and truthful information” with healthcare professionals regarding Vascepa, it should be allowed to promote efficacy data from omega 3 fatty acids clinical trials in patients who have high triglyceride levels despite statin therapy. It also wants to make health claims 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.” Obviously, FDA objects to use of these claims because of “non-conclusive” nature of the clinical trial data, and these claims are not included in the approved label of the drug. Independent healthcare experts agree that additional data is needed to support prevention of heart attacks/ strokes through reducing triglycerides levels. This would be another interesting case in the debate for the distinction between free speech and off-label claims. There is strong precedence of FDA prevailing in such law suits. We will keep you posted on the outcome.
Article Source: Bio-space Breaking News
