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Harvard Health Blog
What “off-label” use of a drug really is, and why you need to know about it
- By Gregory Curfman, MD, Assistant Professor of Medicine, Former Editor-in-Chief, Harvard Health Publishing
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
“…Benefit of an exhaustive and unbiased FDA review…” is an erroneous assumption considering Amarin has won two separate U.S. Federal District Court judgments against the FDA in the short span of three months. Regulatory overreach and failure to abide to internal protocol at the FDA has forced a tiny biopharmaceutical firm to seek relief via the Federal Courts, who twice ruled in the company’s favor. It is indicative of an agency that is more concerned with expanding regulatory oversight, truth be damned, than permitting the free flow of medical research that can ultimately benefit patients.
In the Amarin case, the court’s ruling was more limited than is implied in this article. Amarin sought, and received, preliminary protection from FDA enforcement action against Amarin’s communication of truthful and non-misleading information about Vascepa’s effects in the TG = 200-499 mg/dL and on statin (ANCHOR) population to ONLY PHYSICANS, not also to consumers.
Of course, consumers have had, and continue to have, the right to receive any such information from their physicians.
The practical result of the Amarin case, assuming the preliminary injunction becomes permanent, will be that doctors have the opportunity to be more fully informed, about the results of the ANCHOR clinical trial and other relevant scientific information.
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