• Regulatory NewsRegulatory News

    Comparative Claims in Advertising Make Drugs Seem Safer, More Effective

    Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug Administration (FDA) and published this month. Writing in the journal Social Science & Medicine , FDA Social Science Analyst Amie O'Donaghue and colleagues with FDA's Office of Prescription Drug Promotion (OPDP) and RTI International...
  • Regulatory NewsRegulatory News

    FDA Targets Companies for Facebook 'Likes.' Is Twitter Next?

    Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...
  • Regulatory NewsRegulatory News

    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
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    Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out

    How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising. The study was first announced in October 2013 . At the time, FDA noted that adolescents may understand drug advertisements ...
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    Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know

    The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions." FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously ...
  • FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think)

    Watch a drug advertisement in the US-any one, really-and one thing you're unlikely to hear any mention of is the drug's cost. That's not always an accident, as the myriad of insurance companies, co-pays, state insurance programs, private assistance programs, coupons and other incentives mean that the true cost of a drug is rarely seen by consumers and is rarely the same for two people. But assume, for a moment, that such an instance existed-that a drug ("Drug A") cost ...
  • FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies

    In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, leaving consumers more confused than informed. Now the pharmaceutical industry is weighing in on FDA's call for comments, supporting both its call for additional research and its goal of easing current requirements. Background At present, companies are required to present th...
  • Feature ArticlesFeature Articles

    “Let’s Play Ball:” One Regulatory Reviewer’s Guide to Effective Teamwork

    After a day of reviewing promotional materials at work, I was unwinding at home-flipping through television channels-when I came across a baseball game and thought, "Wow, are we all playing the same game?" I admit I am not an expert at baseball, but I could not help but see some similarities between the game and the world of pharmaceutical advertising and promotion. Bear with me while I try to explain. Imagine…the advertising agency "pitches" an idea to marketing....
  • FDA Releases (its Other) Social Media Guidance

    It may not be the social media guidance members of the pharmaceutical industry have be clamoring for, but the US Food and Drug Administration (FDA) today released a draft guidance document that offers some insight into how the agency thinks companies should use-and not use-social media channels. Background The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FTC), the latter of which has veste...
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    Use of Testimonials and Endorsements in Prescription Drug Advertisements

    Testimonials and endorsements made by patients, healthcare professionals and celebrities are widely used in prescription drug advertising and promotional labeling. The evidence of return on investment from endorsements is inherent through their perpetuity in advertising for drugs and other commodities. For the purpose of this article, endorsements and testimonials will be considered synonymous, with the word "endorsements" used to describe both. Endorsements are defined b...
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    Book Excerpt: FDA Requirements for Prescription Drug Promotion

    RAPS has just published FDA Requirements for Prescription Drug Promotion, written by John Driscoll, an industry veteran who is now a consultant specializing in drug promotion and labeling. In keeping with the September Regulatory Focus theme of advertising, promotion and labeling, following is "Chapter 1 Prescription Drug Labeling," from the book. For more information on the book and the author, see the i nterview with Driscoll in Under RAPS . Introduction Understandi...
  • FDA Seeks to Determine how Consumers Find Health Information Online, Perceive Benefit-Risk

    Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals , and corrective advertising resulting from improper DTC marketing. Now it's making some substantial changes to a DTC study first approved in 2011, according to docu...