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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...
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    Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3

    In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...
  • Changes Coming to Australian Advertising Rules

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...
  • FDA Gets Go-Ahead for Study of DTC Advertising and Social Media

    The US Food and Drug Administration (FDA) will move forward with a survey of healthcare professionals regarding their opinions and perceptions about prescription drug promotion after receiving approval from the Office of Management and Budget (OMB), the executive branch's regulatory clearing house. Background FDA's intent to conduct the survey was first announced in January 2012, when it said in a Federal Register posting that it was soliciting comments on a propo...
  • Could FTC's New Social Media Guidance be Similar to one Pending at FDA?

    If pharmaceutical and medical device companies are eagerly awaiting the US Food and Drug Administration's (FDA) social media guidance for promoting their products using social networks like Twitter and Facebook, a new guidance released by the US Federal Trade Commission (FTC) may provide some insight into how the agency will treat mobile and social advertising. Background: Authority FTC and FDA operate under a slightly unusual agreement in which FTC voluntarily cedes so...
  • Rare Multi-Agency Warning Letter Slams Flu Product

    The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus. The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers...
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    Regulatory Experts Urge Caution With Communications Activities

    The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters. During a panel discussion at 2012 RAPS: The Regulatory Convergence , regu...
  • FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Genentech over marketing materials used to promote its drug Tarceva (erlotinib), used to treat metastatic non-small cell lung cancer (NSCLC). OPDP's letter references a visual aid entitled, " Improving Outcomes in First-Line Advanced Pancreatic Cancer ." The advertisement depicts an adult and child in a mostly-horizontal hourglass on a beach, loungi...
  • Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits

    The US Food and Drug Administration (FDA) is preparing to conduct a survey of prescribing healthcare professionals regarding their assessment of promotional advertising generated by the pharmaceutical industry, including advertising through social media channels, according to a 10 October posting in the Federal Register . "FDA has an interest in determining the attitudes, perceptions, and opinions of healthcare professionals with prescribing authority regarding such...
  • Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits

    Advertisements for over-the-counter (OTC) pharmaceutical products routinely discount the risks associated with a product instead of presenting the same "fair balance" approach mandated for prescription products, say researchers. Writing in the Journal of the American Medical Association (JAMA) , lead researcher Jeremy Greene explained that often when prescription drugs achieve OTC status, the drug's risks disappear from the advertising. "A commitment to fair balan...
  • Regulators to Study use of Composite Scores in Drug Advertising

    Regulators at the US Food and Drug Administration (FDA) are planning to conduct a study on consumers' understanding of composite endpoint scores used in direct-to-consumer (DTC) advertising. Composite scores are essentially a collection of clinical endpoints combined into a single overall score. An allergy drug might, explains FDA, use a composite score that measures a patient's runny nose, congestion, nasal itchiness and sneezing. Do Consumers Understand What a Compo...