• Regulatory NewsRegulatory News

    Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

    Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain. Madigan alleges that Insys illegally marketed its painkiller to doctors who prescribed high volumes of opioid drugs instead of focusing its marketing on oncologists...
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    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
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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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    Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report

    Pharmaceutical companies operating in the EU will need to collect and report information on the off-label use of their medicines under new obligations making their way from draft to final form at the European Medicines Agency (EMA) this summer. In late April, EMA offered a reflection paper , open for comment through 29 July, which offers the agency’s proposal for the collection and reporting of information on off-label use for marketing authorization holders (MAHs), in ...
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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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    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
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    FDA Promotional Enforcement Actions Hit Record Low in 2015

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations. While OPDP has seen a general downward trend in issuing action letters in recent years, 2015 marks the first time the office has issued fewer than 10 letters in a single year. In 2014, OPDP issued 11 letters, though it would later go on to retract one letter to Pacira Pharmaceuticals and li...
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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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    Walking the Digital Tight-Rope

    On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media. Most likely, you are currently reading this on your iPad, smart phone or computer screen as are the majority of people seeking information in this digital-age. To align with current user-practices, Regulatory Focus magazine moved to a completely digital format in 2012. Along the same vein,...
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    Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective

    This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview. Introduction The professional field of regulatory advertising and promotion has become increasingly essential to pharmaceutical companies because of the increased volume of advertisements and promotional materials available to them as well as accessibility to a wide variety of different advertisi...