Court approves Vascepa® for off-label use despite pushback from FDA
On Friday August 7th, the Southern District Court of New York permitted Amarin Pharma to promote certain off-label uses of its 2012 FDA-approved drug, Vascepa®. The FDA has made it known that promoting uses of drugs that are not on FDA-approved labeling violates the Food, Drug, and Cosmetic Act (FDCA). This means that a manufacturer can promote its drug for its approved intended use, but a true and non-misleading promotion of an off-label use is considered misbranding. Doing so is prohibited conduct, and could result in penalties and criminal prosecution.
In accordance with the FDA’s special protocol assessment program, Amarin studied whether Vascepa® could be effective for an off-label use. Under the program, Amarin satisfied the pre-agreed conditions under which FDA would approve the drug for this use. The FDA did not dispute Amarin’s findings, and agreed that Amarin’s study satisfied these pre-established conditions for approval. However, after further examining other manufacturers’ drugs, the FDA determined that a substantial scientific issue existed. Amarin was then warned that Vascepa® may be considered misbranded if it was marketed for the proposed off-label use.
In response to the FDA’s non-approval decision, Amarin filed a complaint against the FDA in the Southern District of New York. Amarin argued that it should be able to promote truthful off-label uses of its drug, particularly as FDA had agreed that Amarin satisfied the study’s endpoints. The Southern District of New York agreed, after relying heavily on precedent from United States v. Caronia, 703 F.3d 149 (2d. Cir. 2012), on the condition that the statements are truthful and not misleading.
While it may seem that the Amarin decision will result in a victory for manufacturers looking to challenge off-label use regulations, they should still heed the following takeaways:
First, the Amarin decision may have a potentially limited impact because of the specific circumstances of the case. Second, the court noted with great detail that “Vascepa’s unusual and extensive regulatory history makes it realistic to determine, at this early stage, the truthfulness of Amarin’s proposed statements regarding its off-label use.” Lastly, the decision highlights the tension between FDA’s interest in overseeing and regulating the safety of the nation’s prescription drugs and the manufacturers’ interest in providing up-to-date, accurate, and truthful information that will benefit patients and providers.
Off-label uses have been the basis of several types of litigation that often confront pharmaceutical companies. Historically, the issue of off-label use has resulted in management liability claims such as directors & officers, qui tam actions, employment practices, and other types of litigation which may involve various types of insurance policies. For further information on this issue, please consult your Gallagher WGA Client Executive.
About the Author
Ann Mizner McKay is the General Counsel and Area Senior Vice President at Gallagher WGA. She manages the legal affairs of the company, and also serves as the Area Claims Practice Leader. Ms. McKay has extensive experience and knowledge in various types of risks including technology, healthcare, business service, environmental, energy, life sciences, financial institutions, and other business risks.