• Regulatory NewsRegulatory News

    Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses

    The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market. Background The bill, known as the CREATES Act and introduced last week , focuses on two tactics often employed by the branded drugmakers to...
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    New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition

    Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products. Backed by 19 physician, pharmacist, hospital and consumer groups, including the Generic Pharmaceutical Association (GPhA), Public Citizen and the largest US pharmacy benefit manager, Express Scripts, the bill, known as the ...
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    FDA Approves New Label for Lower Dose of Abortion Drug

    In a win for public health advocates, the US Food and Drug Administration (FDA) on Wednesday approved new labeling for the abortion drug Mifeprex (mifepristone), supporting its safety and effectiveness when taken at lower doses and later in pregnancy. FDA first approved mifepristone in 2000 as a 600mg dose to end a pregnancy within 49 days of a woman's last menstrual period when taken in combination with misoprostol. However, even before mifepristone was approved, stud...
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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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    FDA Unveils New Website Improvements to Help Industry Keep Track of REMS

    The US Food and Drug Administration (FDA) is making it easier to find information about the controls that police the use of some of the most dangerous drugs approved for use in the US. Background Those controls, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007  Food and Drug Administration Amendments Act (FDAAA)  and are meant to ensure the safe use of potentially risky products that might otherwise not be approved for use. F...
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    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
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    FDA Makes it Easier to Bring Generic Copies of Dangerous Drugs to Market

    A new draft policy issued by the US Food and Drug Administration (FDA) would makes changes to a complicated safety policy in the hopes of making it easier for generic drug manufacturers to make cheaper copies of dangerous drugs. Background To understand FDA's change, you need to understand quite a bit about REMS—Risk Evaluation and Mitigation Strategies. REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to e...
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    FDA Wants to Make Some of the Most Dangerous Drugs Less of a Burden on Companies and Physicians

    The US Food and Drug Administration (FDA) soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs—a collection of restrictions meant to protect patients from potentially dangerous drug products. Background 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—the answer to the qu...
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    Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved

    A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market. Background 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. REMS typically include the following elements: A communication plan, Medicat...
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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...
  • FDA to Consider Giving Sponsors More REMS Communication Plan Options

    Since 2007, the US Food and Drug Administration (FDA) has utilized a set of tools formally known as Risk Evaluation and Mitigation Strategies (REMS) to control and ensure the safe use of dangerous or potentially dangerous drugs. Now the agency says it is looking to make changes to one of the program's more lenient categories, potentially offering companies more-and simpler-options to comply with federal requirements. Background REMS were first introduced under the 2007&...
  • FDA Denies Petition on Guidance for Single Shared REMS, but Agency May Issue in Future

    In May 2013, Prometheus Laboratories submitted to the US Food and Drug Administration (FDA) a citizen petition calling for the establishment of "standards and processes" for single shared Risk Evaluation and Mitigation Strategies (REMS). But in an interesting turn of events, FDA has declined Prometheus' request, saying that while it may issue guidance in the future, it will not be forthcoming at this time. Background In 2007, Prometheus Laboratories purchased Lotronex (...