• Regulatory NewsRegulatory News

    Comparative Claims in Advertising Make Drugs Seem Safer, More Effective

    Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug Administration (FDA) and published this month. Writing in the journal Social Science & Medicine , FDA Social Science Analyst Amie O'Donaghue and colleagues with FDA's Office of Prescription Drug Promotion (OPDP) and RTI International...
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    Using Patient Safety Schemes to Delay Generic Drugs Costs Consumers Billions, Study Finds

    A new report sponsored by the generic pharmaceutical industry claims that branded pharmaceutical companies are using Risk Evaluation and Mitigation Strategies (REMS) to great effect—just not the effect that regulators had intended. Background: What are REMS? REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products. In plain terms, they are meant to keep...
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    Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out

    How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising. The study was first announced in October 2013 . At the time, FDA noted that adolescents may understand drug advertisements ...
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    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
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    Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know

    The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions." FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously ...
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    FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity

    Drug regulators with the US Food and Drug Administration (FDA) are pursuing the development of new technologies to better understand generic—and perhaps even biosimilar—drugs. In a 19 May 2014 funding announcement posted on the National Institute of Health's website, FDA explained that it's seeking help in developing a mathematical algorithm or model it can use to integrate various information to better understand which data can demonstrate "similarity or sameness of t...
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    FDA Releases New Study Format Validation Rules

    The US Food and Drug Administration (FDA) has released a new document intended to provide a recommended approach for submitting study data for drugs and biological products using the Standard for Exchange of Nonclinical Data (SEND) standard. Background FDA accepts—and plans to require—submissions of drug products using electronic data submission formats adhering to accepted standards of formatting. The appropriate use of those standards will soon be of critical importa...
  • FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies

    In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, leaving consumers more confused than informed. Now the pharmaceutical industry is weighing in on FDA's call for comments, supporting both its call for additional research and its goal of easing current requirements. Background At present, companies are required to present th...
  • Report Finds Huge Variations in CDER Performance, but Few Explanations as to Why

    New research published by the Manhattan Institute for Policy Research (MIPR), a right-leaning think tank which focuses in part on pharmaceutical regulation policy, indicates that there are wide gaps in performance among the US Food and Drug Administration's (FDA) review divisions, resulting in a "productivity gap" that has left some patients without ready access to new therapies. Background MIPR's research report, An FDA Report Card: Wide Performance Found Among Agenc...
  • When is a Live Case Presentation Promotional? FDA Draft Guidance Clarifies

    A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) application if the sponsor intends or anticipates including a "live case presentation" during the course of the clinical trial. Background Many high-risk (Class III) "significant risk" medical devices are subject to the premarket application (PMA) process, which requires sponsors to ...
  • UK Formally Launches Early Access Pathway for Neediest Patients

    The UK's Medicines and Healthcare products Agency (MHRA) has announced that it had formally opened a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines. Background The program, known as the Early Access to Medicines Scheme (EAMS), was first announced in March 2014. As described by the UK's Department of Health, EAMS is intended to make the UK "one of the best countries in the world to capitalize on breakthr...
  • EMA Unveils New Adaptive Licensing Initiative, Meant to Provide Earlier Niche Approvals

    The European Medicines Agency (EMA) has announced that it will be launching what it's billing as an "adaptive licensing pilot project," an initiative intended to grant earlier access to medicines meant to treat unmet needs. Unlike the US' accelerated approval pathway, which grants a tentative but wide-ranging approval to a product based on interim data, EMA's adaptive licensing framework calls for the authorization of medicines for restricted (i.e. niche) patient populat...