• Regulatory NewsRegulatory News

    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • Purdue's NDA for Oxycontin Formally Withdrawn as FDA Closes Route to Generic Competitors

    The US Food and Drug Administration (FDA) has announced the withdrawal of a new drug application (NDA) for Purdue Pharma's Oxycontin (NDA #20-553), the very same application that had lost patent protection in April 2013 and had been subject to potential generic competition before FDA said it would not approve any non-abuse-resistant formulations of the drug. Background Under current regulatory policy, approved drugs products are protected by several types of statutory p...
  • Feature ArticlesFeature Articles

    Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3

    In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...
  • Survey of Americans Show Trust in Big Pharma Only Slightly Above Faith in Existence of 'Lizard People'

    • 05 April 2013
    Americans don't particularly trust the pharmaceutical industry. But the extent to which that trust deficit exists is on particularly glaring display in a new survey, which shows that more than one in seven Americans think the pharmaceutical industry is colluding to "invent" new diseases in order to profit off them, and 20% erroneously think vaccines cause autism. Survey Results The survey, conducted by the group Public Policy Polling, approached 1,247 registered voters,...
  • 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 ...
  • FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

    The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products. FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claim...
  • 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...