• Feature ArticlesFeature Articles

    December’s Regulatory Focus: Advertising, promotion, and labeling

    Feature articles during December focused on advertising, promotion, and labeling (APL), examining regulatory review of advertising on streaming media, the role of the regulatory A&P professional, the importance of metrics in APL, and the regulatory outlook for telehealth A&P. Also included is the second part of a two-part series on EU regulation of herbal products, examining quality, safety and efficacy, and postmarket surveillance.   Last year this time, the issue co-...
  • Feature ArticlesFeature Articles

    The regulatory outlook for telehealth advertising and promotion

    The global pandemic has increased the use of telehealth and accelerated its acceptance into mainstream healthcare. However, the regulatory landscape has yet to fully catch up with this expansion of telehealth. This article discusses some of the potential advertising and promotional regulatory implications as telehealth becomes a mainstay in the ever-evolving healthcare sector. The article explores the advertising and promotion of off-label drug prescriptions by telehealth ...
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    Regulatory advertising & promotion: Bringing value beyond the day-to-day

    While the primary goal of the clinical development team is to obtain product approval, companies must have a broader vision that supports the complete product lifecycle. Experts in regulatory advertising and promotion (A&P) have a detailed knowledge of the US Food and Drug Administration (FDA) requirements for product promotion. Beyond supporting the promotional review process, the unique skill set of regulatory A&P should be applied to other critical activities, including...
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    Impact of the COVID-19 pandemic on aspects of regulatory advertising and promotion

    This article discusses the impact of the COVID-19 pandemic on aspects of regulatory advertising and promotion. The author discusses how the shift from print to digital promotional strategies has affected certain elements of the regulatory review process and highlights considerations for carrying these learnings forward after the pandemic.   Introduction Almost a year out from the onset of the pandemic, COVID-19 continues to present challenges for regulatory adverti...
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    Optimizing metadata fields for promotional material review in the US

    Metadata fields are extremely useful tools for classifying and managing the promotional materials used in the commercialization and marketing strategy of pharmaceutical companies and their drugs. Optimizing such fields by implementing various levels of customization and configuration can help individualize the review systems used for promotional material review in the US. These potential changes can strengthen processes to conduct cross-functional, risk-based decision maki...
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    “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 Pledges Enforcement Discretion in Revised Guidance on Labeling

    The US Food and Drug Administration (FDA) has announced the release of its long-awaited draft guidance on the placement, size and prominence of a product's name in advertising and promotional labeling, a development nearly two years in the making. Background The guidance document was first released in January 2012 in final form, part of what FDA said was an effort to clarify the requirements (last issued in 1999) surrounding one of the most visible and important aspec...
  • Analysis: OPDP More Likely to Issue Warning Letters if Drug has Black Box Warning

    Assume for a moment that you're a manufacturer of a pharmaceutical product, one with recognized benefits but enough potential risks to warrant a Boxed Warning on your product's label. Now here's a question for you: Is your product more likely or less likely to eventually receive a Warning Letter from the US Food and Drug Administration (FDA) if you commit an advertising violation relative to a regularly-labeled product? If you answered in the affirmative-that is, mo...
  • OPDP Releases Third Untitled Letter in as Many Weeks

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued a warning to US WorldMeds regarding the online marketing of one of its drugs, Revonto, calling claims made by the company misleading and unsubstantiated. Background The warning, known as an Untitled Letter, is the third posted by OPDP since 24 October. Affected companies include Sunovion Pharmaceutical and Daiichi Sankyo, while a fourth, Aegerion Pharmaceuticals, was sent...
  • Brazilian Regulatory Authorities to Expedite Minor Labeling Changes

    Brazil's national regulatory authority, Anvisa, has announced that its Board has approved an amendment that will permit its regulators to immediately approve minor labeling changes upon notice by a pharmaceutical company. The new rule, approved 12 December 2012, covers changes that pose no risk to the consumer such as safety information and packaging color, size, and layout of patient leaflets and package labeling. According to the CEO of Anvisa, Dirceu Barbano, the ne...
  • 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...