• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

    The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid. According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if the...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Warns Three Companies Over DTC Genetic Tests

    Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared. In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnost...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads

    Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making? These are questions the Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) intends to answer through a two-part study just announced in the Federal Register. Background In addition to reviewing drug ads and promotional labeling "to ensure that the information … is not false ...
  • Regulatory NewsRegulatory News

    What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding

    The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising. Background The study, announced in a 24 June 2015 posting in the Federal Register , is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug ad...
  • RAPS' LatestRAPS' Latest

    Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

    Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. On Wednesday, 3 June, RAPS...