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  • Regulatory NewsRegulatory News

    FDA Warns Company for 'Liking' Status on Facebook

    The US Food and Drug Administration (FDA) has issued a rare Warning Letter chiding a company for, among other reasons, improperly "liking" certain unapproved claims about its product on Facebook. The letter, sent to Utah-based dietary supplement manufacturer Zarbee's, is primarily focused on the company's marketing claims, which FDA says cause the company's products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under federal law, dietary supple...
  • Regulatory NewsRegulatory News

    FDA Guidance: How Can Pharma and Device Companies Use Twitter? Not Easily.

    The US Food and Drug Administration (FDA) today released two guidance documents focused on the use of social media by members of regulated industry, including one on how companies can use the social media platform Twitter and other space-limited platforms. Background The issuance of guidance on social media was required by the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) , Section 1121 of which calls for FDA to, by August 2014, "issue gui...
  • Industry Sees Much not to ‘Like’ in FDA's First Social Media Guidance Document

    In January 2014, the US Food and Drug Administration (FDA) released the first of what it said would be many guidance documents intended to clarify the use of social media by life sciences companies. Now the life science industry is weighing in on that draft guidance, calling for changes and clarifications. Background: Social Media and FDA The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FT...
  • FDA Using Twitter, Telenovelas and Translations to Reach Non-English Speakers

    If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're probably fluent in English and well-versed in medical terminology. Many Americans, though, can't read, can't read or speak English, or can't read or speak English well enough to understand the medical terminology that is necessary to interpret the labels on medical products like...
  • Regulatory Reconnaissance (2 August 2013)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance. In Focus: "Would Have Written About These" Highlights BIO Whitepaper Calls for 12 Years of Biologics Exclusivity in Trade Deal ( BIO ) ( BIO ) BIO, PhRMA, AdvaMed, GPhA, MITA Join Together to Support Senate Bill to Exempt FDA User Fees from Se...
  • 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...
  • In Midst of Crackdown, New Batch of FDA, FTC Warning Letters Target Unapproved Flu Products

    The US Food and Drug Administration (FDA) has released a bevy of new warning letters all aimed at "unapproved flu products," part of a recent crackdown by the agency on products it deems to be either ineffective or potentially dangerous. Background The 2012/2013 flu season has been a particularly strong one in the US, and high public demand for flu vaccinations has put FDA on edge, and for good reason: The combination of drug shortages and public concern is a potent rec...
  • The 25 Regulatory Twitter Accounts You Need to be Following

    Here at Regulatory Focus , we love Twitter. The micro-blogging website, occasionally more noted for its celebrity handles, parody accounts, over-shared information and boring observations is also something most people don't realize: an excellent tool for gathering regulatory intelligence. Call it social media regulatory intelligence, if you will. Between the editors and other staff here at Focus , we follow over a thousand people on Twitter, ranging from reporters to ...
  • Clock Starts Ticking on Issuance of FDA's Social Media Guidance

    The end is near-for marketing professionals waiting for the US Food and Drug Administration (FDA) to issue its long-discussed and long-delayed guidance on the appropriate use of social media for marketing healthcare products, that is. Buried deep within the FDA Safety and Innovation Act (FDASIA), signed into law on 9 July 2012 by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014. "Not later than 2 years aft...
  • Watermelon and Web-links Form Basis of Drug Promotion Complaint Against Swedish Company

    • 25 June 2012
    [ Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not responsible for the website. ] The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to Swedish Orphan Biovitrum AB for allegedly making misleading claims regarding the safety and efficacy of Kepivance (palifermin) on a w...
  • Warning Letter Analysis: Device Companies Hit for Marketing, Social Media Problems

    • 13 June 2012
    Alleged marketing deficiencies were the subject of nearly identical warning letters sent to two separate manufacturers of hypoerthermic medical devices, both of whom were accused of using online advertisements to promote their respective devices for conditions not cleared or approved by the US Food and Drug Administration (FDA). ThermaSolutions Incorporated (Medical Device)  [See: 22 June 2012 Update] In its 7 May warning letter to Minnesota-based medical device ...
  • DHHS Looks to Social Media for Warning Signals

    • 22 March 2012
    A new US Department of Health and Human Services (DHHS) initiative is looking to use social media tools-specifically the micro-blogging website Twitter-to provide the agency with advanced signals to help identify public health emergencies. In a 20 March press release, DHHS said it is looking for developers to create tools that look at real-time data on public health issues, with a particular focus on illnesses. The agency hopes to develop a tool that will be "useful as ...