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From Health Law Daily, August 10, 2015

Hold your horses, FDA: no misbranding action for truthful off-label promotion

By Kayla R. Bryant, J.D.

A pharmaceutical company was granted relief to ensure that it can engage in truthful, constitutionally protected speech promoting a drug for off-label use, despite threats of a misbranding action from the FDA. The U.S. District Court for the Southern District of New York declared that Amarin Pharma, Inc (Amarin) may promote Vascepa® for off-label use and that truthful and non-misleading speech may not be used as the basis for a misbranding prosecution. Additionally, the statements and disclosures about the drug Amarin intends to make to doctors regarding the use of Vascepa to treat patients with persistently high triglycerides as presented to the court are deemed to be truthful and not misleading (Amarin Pharma, Inc v. FDA, August 7, 2015, Engelmayer, P.).

Vascepa. The FDA approved Vascepa to be marketed for treating adult patients with very high triglyceride levels (above 500 mg/dL of blood), which places them at risk for pancreatitis and cardiovascular disease. Amarin sought, but did not receive, approval to market the drug for use in patients whose triglyceride levels were between 200 and 499 mg/dL of blood and who were already using statin therapy (persistently high triglycerides). Although the FDA confirmed that Vascepa is effective in reducing triglyceride levels in this range, following an agency approved study known as the ANCHOR study, the FDA is not convinced that reducing triglycerides from this range reduces the risk of cardiovascular disease, which was the clinical rationale for the study.

Off-label marketing. After receiving the denial, Amarin brought this action alleging that it wished to make truthful statements to doctors regarding ANCHOR study results. However, Amarin stated that the FDA’s threat of bringing a misbranding action following off-label promotion included in the Complete Response Letter (CRL) inhibited its ability to engage in protected speech. In the complaint, Amarin stated that prescribing drugs to lower persistently high triglyceride levels is a medically-accepted practice because doctors believe that drug therapy is the best treatment, even though there is a lack of clinical evidence demonstrating that lowering these levels reduces cardiovascular risk. The complaint also alleged that the FDA had, until recently, permitted other manufacturers of similar drugs to market their drugs as reducing persistently high triglycerides. It stated that the ban on off-label promotion of Vascepa prohibited Amarin from making the same health claims that the FDA has allowed dietary supplement manufacturers to make about consuming omega-3 fatty acids.

Amarin requested relief recognizing that the relevant prohibitions on off-label promotion were unconstitutional under the First Amendment. It requested general protection to engage in truthful and non-misleading speech intended to promote the drug for off-label use with doctors. It also specifically requested permission to make three particular “carefully-circumscribed, truthful, and scientifically-accurate statements” based on FDA-approved language, including the ANCHOR study and CRL letter. It proposed to make five particular disclosures about the lack of FDA approval for this particular use to ensure that statements were not misleading, and proposed presenting doctors with peer reviewed publications and a summary of the ANCHOR study. Amarin stated that the company and its employees feared criminal prosecution for engaging in truthful off-label promotion. It moved for preliminary relief seeking an injunction prohibiting the FDA from bringing a misbranding action for making these statements.

The FDA acquiesced to the distribution of truthful and non-misleading summaries of the ANCHOR study, as long as they were accompanied by specified disclosures. It asked that Amarin provide copies of current approved labeling and a reprint of a particular journal article. It asked that the information be distributed by people with appropriate background or training, and in “educational or scientific settings, and not including such information with or attached to promotional or marketing materials.” The FDA argued that this letter of acquiescence mooted the controversy.

Caronia case. In U.S. v. Caronia in 2012, the Court of Appeals for the Second Circuit vacated a drug sales representative’s conviction for conspiring to sell a misbranded drug due to promoting said drug for off-label use. The court held that the misbranding provision of the Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §331(a)) must be construed as “not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs” in instances where the off-label use is not prohibited. This decision’s reasoning was based upon the protection of free speech under the First Amendment.

The court noted that because Amarin did not accept the FDA’s proposed conditions, the letter did not moot the controversy or eliminate the risk of a misbranding action. The court also closely reviewed Caronia, and determined that the ruling prohibits the FDA from bringing a misbranding action based on truthful promotional speech alone. The district court considered the FDA’s approval of the ANCHOR study and written confirmation that Vascepa is effective in reducing persistently high triglycerides and noted that Amarin has based almost all of the proposed communications on FDA statements. It found that the dissemination of the peer-reviewed publications, ANCHOR summary, and agreed-upon disclosures would not be false or misleading.

Disputed disclosures. The court reviewed the submitted drafts and revisions of a disputed disclosure stating that the FDA had not approved Vascepa for the treatment of persistently high triglycerides, as well as the FDA’s reasoning. It found that neither parties’ draft was optimal, and created a disclosure that it deemed truthful and non-misleading. A second disputed disclosure written by the FDA stating that studies have failed to demonstrate a cardiovascular benefit of adding a second lipid-altering drug for those patients undergoing statin therapy who still had high triglyceride levels, had been opposed by Amarin as unnecessary. However, in the event that the court held such a disclosure was necessary, the company had provided a modified version. The court decided to err on the side of providing more information to doctors, and declared that Amarin’s modified version of the disclosure was factual and non-misleading. Both of the disputed disclosures can be revisited and revised throughout the litigation.

The FDA had opposed other statements regarding the use of omega-3 fatty acids to reduce the risk of coronary heart disease, as it did not include information about Vascepa’s use along with other treatments such as statin therapy and healthy diets. The court found that the statement was presently truthful and non-misleading. Amarin is permitted to make all of its desired claims included in this litigation, along with the modified disputed disclosures and statements, without fear of a misbranding action based on truthful, non-misleading speech. The court placed upon Amarin the responsibility to assure that its communications remain truthful and non-misleading in the future as new information is obtained.

The case is 15 Civ. 3588 (PAE).

Attorneys: Floyd Abrams (Cahill Gordon & Reindel LLP) for Amarin Pharma, Inc. Ellen Melissa London, U.S. Attorney Office SDNY, for U.S. Food & Drug Administration, United States of America, M.D. Stephen Ostroff and Sylvia Mathews Burwell.

Companies: Amarin Pharma, Inc.

MainStory: TopStory CaseDecisions MisbrandingNews FDCActNews DrugBiologicNews PrescriptionDrugNews LabelingNews SupplementNews NewYorkNews

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