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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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    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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    AMA Calls to Ban DTC Advertising for Drugs, Medical Devices

    Physicians at the American Medical Association (AMA) on Tuesday called to ban direct-to-consumer (DTC) advertising for drugs and devices because of the negative impact of the commercially driven promotions. Physicians revealed concerns that the increase of ads in the US (only the US and New Zealand allow DTC advertising for drugs and devices) is driving demand for newer, more expensive treatments even though less-costly alternatives may be more effective. AMA Board Chai...
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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...
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    Evolution of Advertising and Promotion Review Systems

    This article addresses the evolution of review systems used for advertising and promotion materials. Promotional review and approval, at its root, is designed to ensure all marketing and sales materials for pharmaceuticals are compliant with established legal, regulatory and medical standards, as well as company policies and procedures. Pharmaceutical companies employ cross-functional teams applying standard principles of education and training and good judgment to eva...
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    Prescription Drug Advertising Versus Non-Advertising Promotion in China: Contrasting Regulation

    This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China. On 1 September 2015, several new requirements for the regulation of prescription drug advertising in China were implemented. (1) Recent legislative amendments to China’s Advertising Law , (2) the first significant revision of the statute since 1994, and corresponding proposed revisions to review standards and administrati...
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    Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors

    This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies. Pharmaceutical companies promote their prescription drug products for a number of reasons, including to increase consumer awareness and the number of physicians prescribing the drugs and ultimately, to drive sales. Since these prescription products may carry serious risks, their promotion is r...
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    FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads

    As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...
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    Stories From the Promotional Review Battlefront

    This article shares advertising and promotion experiences and presents strategies to improve a team's performance. It was the best of times, it was the worst of times… sounds like an ad/prom review team meeting. Many companies have a cross-functional team responsible for reviewing and approving advertising and promotional materials. This team and their meetings are known by many names: Promotional Review Committee (PRC), Medical/Legal/Regulatory (MLR), Medical/R...
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    The Evolving Approach of Presenting Risk Information to Consumers

    This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...
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    Celebrity Endorsements—Lights, Camera, Enforcement Action?

    This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.  Celebrities grab attention everywhere they go. In fact, it is what they are paid to do when they endorse a pair of sneakers or an underwear brand. Just look at William Shatner, best known as Captain James Kirk from Star Trek, who has everyone humming “Price-Line-Negoti-ator!” Or hear Samuel L. Jackson asking, “What’s in your wallet?” each time someone t...