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  • 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...
  • FDA Approves Generic Doxil to Ease Drug Shortages

    The US Food and Drug Administration (FDA) has announced the approval of a generic version of a critical cancer drug that it has been allowing to be imported for almost a year under a rare exercise of its enforcement discretion intended to alleviate drug shortages. Background In late 2011, regulators became aware of mounting drug shortages they said were caused by several factors, but most notably manufacturing problems found at a number of facilities that made sterile...
  • 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 ...
  • Exclusive: FDA to Continue Regulatory Exception for Doxil Substitute

    The US Food and Drug Administration (FDA) plans to continue to allow a substitute for the anti-cancer drug Doxil, manufactured by Johnson & Johnson subsidiary Ben Venue Laboratories, into the country in the near future despite Ben Venue's 17 October announcement that it has resumed production at its Bedford, Ohio facility. Ben Venue suspended the majority of manufacturing activities at its Bedford plant in November 2011 after inspectors from FDA identified a series o...
  • Feature ArticlesFeature Articles

    FDA Regulation of Healthcare Product Advertising on Social Media

    Social media offers exciting new approaches to marketing products, but the medical products industry has been slow to participate. Social media communications can be daunting for many reasons: it is public, continuous, interactive and global, and there are often extreme space limitations. Many in the medical device industry point to a lack of US Food and Drug Administration (FDA) guidance 1 as one of the main reasons for caution. In a survey by Massachusetts trade asso...
  • India Pharma Reps Protest Corruption, Drug Prices

    • 28 August 2012
    Pharmaceutical sales representatives in India went on strike to protest treatment of the reps, increasing drug prices and corporate corruption in their industry, according to PMLive . The one-day strike was held on 23 August and organized by the Federation of Medical and Sales Representatives Associations of India (FMRAI). The group's newsletter said widespread corruption is creating attacks on the job security of sales reps, including an increase in reps being banned...
  • Drug Reformulations Lead to Shifting Patterns of Abuse

    A report in the New England Journal of Medicine (NEJM) found abuse of a OxyContin, a branded version of the opioid oxycodone, went down significantly between 2010 and the first quarter of 2012 as the result of a new time-release formulation released in August 2010 by Purdue Pharma. The reformulation made it more difficult to turn the medicine into a powder, thereby reducing an abuser's ability to snort or inject the medication. The article, by Theodore Cicero, PhD, of ...
  • 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 ...
  • Senators Launch Investigation Into 'Dubious Marketing Practices' of Pain Pill Manufacturers

    • 10 May 2012
    Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson, which are alleged to have engaged in "misinformation and dubious marketing practices." The Senators, Max Baucus (D-MT) and Charles Grassley (R-IA), charge the companies were involved in establishing "improper relationships between [the companies] and the organizati...
  • 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 ...