• MHRA Publishes New Edition of 'Blue Guide' on Medicinal Advertising, Promotion

    The Medicines and Healthcare products Regulatory Agency (MHRA) 3 April announced 3 April it has published a draft of the third edition of its Blue Guide-a guide to the advertising and promotion of medicines in the UK. "This new edition updates our guidance on advertising medicines in a number of areas, including providing information before the grant of a marketing authorisation and using digital communications," writes MHRA on its website. "We have extended the introduc...
  • FDA Reopens Comment Period on DTC Advertising Regulations

    The US Food and Drug Administration (FDA) announced this week it is reopening a comment period on a proposed rule on presenting major statements in director-to-consumer (DTC) advertisements, extending comments for an additional 15 days. The 23 March Federal Register notice follows an initial posting on 27 January, entitled Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescriptio...
  • Court Upholds FDA Labeling Regulations on Cigarette Packaging

    The Cincinnati Court of Appeals has upheld the US Food and Drug Administration's (FDA) authority to require cigarette companies to adorn their tobacco products with graphic labeling, ruling FDA's advertising regulations do not violate the companies' rights to free speech. "There can be no doubt that the government has a significant interest in preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products," wrote...
  • New FDA Draft Guidance on DTC Television Advertisements

    The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public. Guidance for Industry - Direct-to-Consumer Television Advertisements - FDAAA DTC Television Ad Pre-Dissemination Review Program "describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under...
  • Veterans Affairs Sets New Regulations For Marketing Practices

    The US Department of Veterans Affairs (VA) issued a new regulation on 9 March that restricts access to facilities owned by the VA. Representatives of pharmaceutical companies will be subject to much stricter regulations governing their ability to engage in promotional, educational and conversational activities with VA staff. Pharmaceutical representatives will be required to: Disclose their company ties at the beginning of talks Portray all information accurately Giv...
  • FTC Considering New Guidance on Social Media, Advertising

    The US Federal Trade Commission (FTC), the governmental body that oversees advertising regulation in the US, is considering new guidance for disclosures in online advertisements, particularly advertisements in social media platforms. FTC will hold a workshop on 30 May to discuss the topic with stakeholders, as well as discuss the possibility of updating existing guidance known as the "Dot Com Disclosures." FTC anticipates discussing: "How can effective disclosures be ...
  • FDA Plans Study on Corrective DTC Advertising

    The US Food and Drug Administration (FDA) is calling for a study on corrective direct-to-consumer (DTC) advertising and its impact on correcting misperceptions about a product's safety and efficacy for a given indication. "FDA regulations require prescription drug advertisements to contain accurate information about the benefits and risks of the drug advertised.  When this is not the case, corrective advertising is designed to dissipate or correct erroneous belief...
  • FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Regulation

    The US Food and Drug Administration (FDA) released the results of a new study on 27 January that explores the impact of distraction on a consumer's understanding of important information in direct-to-consumer (DTC) television advertising. The study , Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements , was conducted in response to a proposed...
  • FDA Provides New Guidance for Promotional Labeling and Advertising

    The US Food and Drug Administration (FDA) released a new guidance for industry on 24 January on the placement, size and prominence of a product name in promotional labeling and advertising. The final guidance, Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling , "is intended to clarify the requirements" for prescription medicinal products for both humans and animals. FDA notes that the proper use of a product's name is important in e...
  • British Surgeons Group Calls for Ban on Cosmetic Surgery Advertising

    • 23 January 2012
    A British Surgeons group is calling for the cessation of cosmetic surgery advertising in light of what it sees as "marketing gimmicks" that lead to unsafe and unnecessary surgeries. The President of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah told BBC news that "the many aggressive marketing gimmicks [not] only trivialize surgery but endanger the patient." Fatah further noted that patients are victim to "unrealistic expectations", "cras...
  • Proposed FDA Study to Look at DTC Advertising, Social Media

    The US Food and Drug Administration (FDA) announced today that it is planning on conducting a survey of healthcare professionals regarding their opinions and perceptions of prescription drug promotion directed at consumers and healthcare providers. FDA's Federal Register posting notes that consumers and providers alike are subject to direct-to-consumer (DTC) advertising from pharmaceutical companies, and that questions have been raised regarding the influence of these ...
  • MHRA: Agency Able to Clear 95% of Advertising Pieces within 5 Working Days in 2011

    The Medicines and Healthcare products Regulatory Agency (MHRA)  released data today indicating that they were able to clear, on average, 95% of advertising pieces submitted to the agency for vetting within their aimed-for time of five working days. MHRA was able to clear all advertising pieces  submitted to them during the months of  May, July, October and December, but their average was brought down by their performance in February (91%), August (89%) a...