Amarin, along with 4 independent physicians, filed a lawsuit against the FDA. This was to defend its right to dispense information about unapproved uses of a medicine. Amarin argued that it was protected in doing this by the First Amendment.
Amarin, along with 4 independent physicians, filed a lawsuit against the FDA. This was to defend its right to dispense information about unapproved uses of a medicine. Amarin argued that it was protected in doing this by the First Amendment.
Amarin vs. FDA
The core of the lawsuit was based on Amarin’s wish to provide physicians with clinical data not related to the current approved use of the drug. The drug in question, Vascepa, is approved to treat consumers with very high levels of triglycerides which could lead to heart disease. However, they have clinical data on the efficacy of treating consumers with lower triglyceride levels.
The FDA rejected their bid to market this drug to the additional patient population and for it to be added to their brand labeling. So it would be considered off-label by the FDA. This is a fascinating case, where Amarin strongly believe that they have a constitutional right to distribute this information and are steadfast in their belief that their claim does, in fact, meet all requirements.
This case has many implications for the Pharma industry. Of course, physicians are able to prescribe a drug for whatever they think it will work for. However, Pharma have had numerous fines imposed by U.S. authorities for off-label use discussions on their products. The FDA feels that by allowing off-label use, companies would effectively be getting around the whole approval process.
This brings to mind a lawsuit that happened 3 years ago around the conviction of a sales rep for promoting off-label data for use of a drug to doctors. That ruling was overturned as the court decided that the FDA violated the rep’s right to free speech under the First Amendment. They argued that it was permissible as long as it was not misleading and was honest.
Fascinating case.