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    Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report

    Pharmaceutical companies operating in the EU will need to collect and report information on the off-label use of their medicines under new obligations making their way from draft to final form at the European Medicines Agency (EMA) this summer. In late April, EMA offered a reflection paper , open for comment through 29 July, which offers the agency’s proposal for the collection and reporting of information on off-label use for marketing authorization holders (MAHs), in ...
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    New Studies Push FDA to Expand Label for Popular Diabetes Drugs

    Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. Prior to the label change, metformin, which at least one researcher has said is "little removed from a herbal remedy of the middle ages," was stro...
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    FDA Requires New Labels for Opioids

    The US Food and Drug Administration (FDA) on Tuesday announced class-wide safety labeling changes for immediate-release (IR) opioid pain medications, which make up about 90% of all opioid prescriptions. The labels now include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on their risks, w...
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    Harvard Professors Call for Science-Based Pharma Marketing

    Two Harvard professors are taking issue with the recent landmark court decision allowing some "truthful and non-misleading" off-label pharmaceutical marketing in a new paper, saying “informativeness in asserting scientific facts, rather than truthfulness, ought to be the gold standard for evaluating commercial speech about pharmaceuticals.” Background The US Food and Drug Administration (FDA) generally does not allow pharmaceutical companies to promote drugs for unappro...
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    FDA, Amarin Propose to Settle Landmark Off-Label Marketing Case

    Amarin and the US Food and Drug Administration (FDA) late Tuesday announced the proposed settlement terms of a major First Amendment lawsuit over the off-label promotion of a drug. The settlement comes as FDA and Amarin have been battling in court for a little less than a year over Amarin’s dissemination of promotional materials to doctors on an unapproved indication for its triglyceride lowering drug Vascepa (icosapent ethyl). The lawsuit was linked to Amarin’s int...
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    Amarin, FDA Seek One More Month to Hash Out Off-Label Promotion Settlement

    Biopharma company Amarin and the US Food and Drug Administration (FDA) have jointly requested one more month to try to settle a landmark off-label promotion lawsuit. This is the third call for an extension to the settlement talks and it comes six months after the US District Court for the Southern District of New York court ruled in August that Amarin can make certain truthful and non-misleading statements about off-label uses of its omega-3 drug Vascepa (icosapent eth...
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    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
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    DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses

    A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses. The jury instructions, filed earlier this month by Richard Durbin, Jr., the US Attorney for the Western District of Texas, explain what speech is illegal under the Food, Drug, and Cosmetic Act (FDCA) in ...
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    FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration

    The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems. Background With the passage of the 2007 Food and Drug Administration Amendments Act , FDA was granted the authority to require manufacturers to develop REMS for new and approved products. These plans are intended to enable companies to better manage know...
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    Court Sides With Amarin in Off-Label Suit

    On Friday, a New York Court sided with biopharmaceuticals maker Amarin in a suit against the US Food and Drug Administration (FDA) involving the off-label promotion of Vascepa. Background Vascepa was initially approved by FDA to reduce triglyceride levels in adults with severe hypertriglyceridemia. As reported by the FDA Law Blog , Amarin hoped to expand Vascepa's indication after learning that some doctors were using Vascepa off-label to treat patients with persist...
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    Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

    The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated. Background As Regulatory Focus has previously reported , the Supreme Court had been petitioned to hear an appeal of the federal court case  Planned Parenthood v. Humble —a case challenging a 2012 Arizona law which makes i...
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    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....