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  • 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...
  • 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 ...
  • 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...
  • 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...
  • Report: As Pharma Goes Global, So Do Charges of Corruption

    • 29 February 2012
    A report by Reuters has found that increasingly global pharmaceutical companies are running up against many of the same charges of influence peddling and corruption abroad that they once faced at home. The charges could affect more than just the companies' reputations. "In recent years, Big Pharma has forked out billions of dollars to settle scandals involving improper promotion of medicines in the United States.  Now bribes paid to foreign doctors and other st...
  • Industry: GDP Guidelines Would Increase EU Costs

    • 22 February 2012
    Big pharmaceutical and logistics companies say draft good distribution practice (GDP) guidelines from the European Commission would "significantly increase the cost of medicinal product supply chains," according to a published report by Outsourcing Pharma .  The statement is attributed UPS, a worldwide shipper, that is concerned about the classification of any period when products are held at a site for longer than 24 hours as a regulated activity.  The r...