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  • Regulatory NewsRegulatory News

    Do Biopharma Companies Really Spend More on Marketing Than R&D?

    As the drug pricing debate on Capitol Hill continues, the debate over how biopharma companies spend also continues. From 2014 through 2016, various publications—from the Washington Post to Vox to MedCity News —published an eye-opening chart showing that nine of the top 10 large pharmaceutical companies (all but Roche) spent more on marketing than research and development (R&D). The source of the chart is a 2014 BBC article , which relied on GlobalData, to...
  • Regulatory NewsRegulatory News

    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
  • Regulatory NewsRegulatory News

    Marketing Status Notifications: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs. Thanks to the FDA Reauthorization Act of 2017 , drugmakers are required to provide additional information regarding the marketing status of approved drug products, includ...
  • Regulatory NewsRegulatory News

    One-Time Marketing Status Reports Due in February, FDA Says

    The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale. Reports are due 14 February and are required under a provision from the law reauthorizing the user fee programs. "The NDA or ANDA holder can submit the one-time report to FDA ...
  • Feature ArticlesFeature Articles

    Marketing Exclusivity for Over-the-Counter Switched Products

    This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...
  • Regulatory NewsRegulatory News

    Medtronic Settles Deceptive Advertising Lawsuit for $12M

    State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multi-state settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse. The complaint alleged that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about the device’s safety, comparative efficacy and superiority to expand its market. Spec...
  • Regulatory NewsRegulatory News

    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
  • Regulatory NewsRegulatory News

    EMA Backs Six Drugs, One Biosimilar for EU Approval

    The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval. The six medicines the agency is recommending are: Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation; Merck Sharp & Dohme's Pr...
  • Regulatory NewsRegulatory News

    10 Years in, EU Pediatric-Use Marketing Authorization Called a 'Disappointment'

    Biopharmaceutical companies and regulators across Europe have said that in the 10 years since the Pediatric Regulation took effect, some pediatric therapeutic areas have seen progress, though the pediatric-use marketing authorization (PUMA) has not lived up to expectations. Overall, according to a summary of the comments received from 75 stakeholders on the consultation from last November , the European Commission noted that the reward system built into the regul...
  • Regulatory NewsRegulatory News

    EMA Offers New EudraVigilance Checklist for Sponsors, MAHs

    The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017. The checklist features general testing instructions and easy-to-follow steps to assist sponsors and MAHs in the transition. In addition, EMA notes that the ICH E2B(R3) Implementation Guide and the EU ICSR Implementation...
  • Regulatory NewsRegulatory News

    EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events

    The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events. In the lead up to the launch of the new EudraVigilance system, EMA says national competent authorities, marketing authorization holders (MAHs) and sponsors of clinical trials have to make  final preparations  to ensure that their processes and IT infrastructures can work with the new...
  • Regulatory NewsRegulatory News

    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...