• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Considers Some DTC Drug Ads (4 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Changes to Oversight of Low-Risk OTC Products The Therapeutic Goods Administration (TGA) of Australia has put forward proposed changes to the regulation of low-risk products for consultation. TGA is seeking feedback on whether it should free some over-the-counter (OTC) medicines from the need to go through premarket assessments. Currently, TGA c...
  • Regulatory NewsRegulatory News

    FDA Warns Two Pharma Companies Over Misleading Ads

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements. One of the warnings was sent to Salt Lake City-based Spiraso due to “false or misleading claims and/or representations about the risks associated with Tuxarin ER” on the company’s website. Tuxarin is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Prepares Changes to Advertising Complaints Process The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get...
  • Regulatory NewsRegulatory News

    FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine). The letter, the fifth of which was issued this year by OPDP (the last one was issued in September), focuses on the video’s use of the general terms “e...
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    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...
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    DTC Drug Advertising: FDA to Launch First Public Survey Since 2002

    Direct-to-consumer (DTC) advertising for pharmaceuticals has been a hot topic recently as federal and state officials have questioned their utility, particularly as the US and New Zealand are the only two countries in the world that have them. Now, the US Food and Drug Administration (FDA) is looking to survey patients about their experiences with DTC drug ads. The survey will question respondents about their knowledge of FDA's authority over prescription drug advertisi...
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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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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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    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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    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...