• Regulatory NewsRegulatory News

    Off-Label Promotion: Researchers Call on Courts to Reject Caronia

    Two researchers are calling for the US Food and Drug Administration (FDA) to take a stand against off-label promotion in light of recent legal proceedings, and urge the courts to reject the precedent set in United States v. Caronia . The call comes during a time of uncertainty for the future of off-label promotion and just one week before FDA's upcoming two-day public hearing on off-label communications. In Caronia , the Second Circuit Court of Appeals reversed the ...
  • Feature ArticlesFeature Articles

    Do Recent First Amendment Court Developments Deal a Blow to the Government?

    This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications. Introduction The US Food and Drug Administration has suffered two widely-publicized setbacks relating to off-label promotion oversight. In both cases—one involving a pharmaceutical company (Amarin) and the other a medical device firm (Vascular Solutions) and its chief executive officer—the governmen...
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    Regulatory Advertising and Promotion: Exploring the Past and Present to Understand the Future

    This article provides a chronological overview of legislative milestones shaping the landscape of regulatory advertising and promotion. It reviews standards for prescription drug promotion and summarizes important cases involving off-label promotion with the purpose of showing that while interpretation for what is considered truthful and not misleading has been changing, regulations defining them have not changed. Introduction For those working in regulatory advertisi...
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    FDA Begins Process of Overhauling Off-Label Communications Regulations

    The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices. The hearing comes as FDA has come under fire recently for its limiting of what drug and device industries consider to be “free speech.” In March, FDA settled a lawsuit with drugmaker Amarin after the US District C...
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    ‘Truthful and Non-Misleading’: GOP Reps Take Issue With FDA’s Handling of Off-Label Marketing

    The tricky part about the off-label marketing of drugs, or the marketing of drugs to doctors for unapproved indications, is that companies, and not the US Food and Drug Administration (FDA), may get to decide what some courts are referring to as “truthful and non-misleading” marketing information. Republican Reps. Fred Upton (MI) and Joe Pitts (PA) on Thursday took FDA to task for the agency’s “inability or unwillingness to publicly clarify its current thinking” on off-l...
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    Harvard Professors Call for Science-Based Pharma Marketing

    Two Harvard professors are taking issue with the recent landmark court decision allowing some "truthful and non-misleading" off-label pharmaceutical marketing in a new paper, saying “informativeness in asserting scientific facts, rather than truthfulness, ought to be the gold standard for evaluating commercial speech about pharmaceuticals.” Background The US Food and Drug Administration (FDA) generally does not allow pharmaceutical companies to promote drugs for unappro...
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    FDA, Amarin Propose to Settle Landmark Off-Label Marketing Case

    Amarin and the US Food and Drug Administration (FDA) late Tuesday announced the proposed settlement terms of a major First Amendment lawsuit over the off-label promotion of a drug. The settlement comes as FDA and Amarin have been battling in court for a little less than a year over Amarin’s dissemination of promotional materials to doctors on an unapproved indication for its triglyceride lowering drug Vascepa (icosapent ethyl). The lawsuit was linked to Amarin’s int...
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    Amarin, FDA Seek One More Month to Hash Out Off-Label Promotion Settlement

    Biopharma company Amarin and the US Food and Drug Administration (FDA) have jointly requested one more month to try to settle a landmark off-label promotion lawsuit. This is the third call for an extension to the settlement talks and it comes six months after the US District Court for the Southern District of New York court ruled in August that Amarin can make certain truthful and non-misleading statements about off-label uses of its omega-3 drug Vascepa (icosapent eth...
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    DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses

    A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses. The jury instructions, filed earlier this month by Richard Durbin, Jr., the US Attorney for the Western District of Texas, explain what speech is illegal under the Food, Drug, and Cosmetic Act (FDCA) in ...
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    Court Sides With Amarin in Off-Label Suit

    On Friday, a New York Court sided with biopharmaceuticals maker Amarin in a suit against the US Food and Drug Administration (FDA) involving the off-label promotion of Vascepa. Background Vascepa was initially approved by FDA to reduce triglyceride levels in adults with severe hypertriglyceridemia. As reported by the FDA Law Blog , Amarin hoped to expand Vascepa's indication after learning that some doctors were using Vascepa off-label to treat patients with persist...