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  • Regulatory NewsRegulatory News

    OPDP warns AcelRx over Dsuvia promotional materials

    In its first warning letter of the year, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for its opioid analgesic Dsuvia (sufentanil sublingual tablet).   Specifically, the warning letter cites the company for false and misleading claims made in banner ads and a tabletop display that feature a tagline promoting the ease of administration of Dsuvia as “Tongue a...
  • Feature ArticlesFeature Articles

    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
  • Feature ArticlesFeature Articles

    December's Regulatory Focus: APL and the role of social media

    December 2020. It’s been just one year since we finished the last Regulatory Focus issue on advertising and labeling, yet it feels like a lifetime. In March, as the true impact of COVID-19 kicked in and we retreated from the office space to our home offices, it was hard to envision how we would prevail, both personally and professionally. But our industry, and particularly regulatory advertising and labeling, did not skip a beat and instead, stayed the course and perseve...
  • Feature ArticlesFeature Articles

    Preparing for advertising and promotion eCTD submissions in the US

    This article provides the sponsor’s perspective and best practices on facilitating electronic common technical document (eCTD) submissions for promotional materials as a shared learning for other companies.   Introduction The long-awaited June 2019 guidance 1 on regulatory submissions in electronic and nonelectronic format marked the beginning of a two-year countdown for sponsors to submit promotional materials in eCTD format to the Office of Prescription Drug Pro...
  • Regulatory NewsRegulatory News

    FDA to Survey Healthcare Professionals on Prescription Drug Marketing

    The US Food and Drug Administration (FDA) on Friday announced it will go ahead with a survey of healthcare professionals (HCPs) on how they are impacted by prescription drug promotion aimed at a professional audience.   The announcement comes after the agency consulted on its plans for  the survey in March 2018 and follows two earlier surveys that looked at HCPs’ attitudes toward direct-to-consumer (DTC) advertising. The survey will also include questions about HCPs’...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Promotional Drug Labeling and Ads

    The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised dr...
  • Regulatory NewsRegulatory News

    DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List

    A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed. "When commercials list severe side effects along with those that are most frequent…it dilutes consumers' judgements of the overall severity of the side effects," write authors Niro Sivanathan, associate professor of org...
  • Regulatory NewsRegulatory News

    FDA Weighs Limited Risk Info in DTC Ads

    The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented. Currently, DTC drug ads are required to present a product's major risks alongside its benefits to ensure a "fair balance" of information. But FDA and industry have long debated over the best way to present that information. Acc...
  • Regulatory NewsRegulatory News

    PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion

    The pharmaceutical industry lobbying group is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health. "FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further pro...
  • Regulatory NewsRegulatory News

    FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

    A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks. According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also impro...
  • Regulatory NewsRegulatory News

    Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising

    Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system." With the intention of addressing the criticisms of the current system from a public consultation on  the regulatory framework for advertising therapeutics  in November 2016, the decision means all complaints...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain br...