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    FDA To Disclose Unredacted Advisory Committee Members' CVs

    In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members. A consent form saying the member’s CV does not include any confidential information will need to be submitted, FDA said. Background FDA maintains about 50 advisory committees comprised of outside experts who weigh in on scientific and medical issues, and which typically convene ...
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    FDA Helps Fund 21 Early Phase Trials for Rare Disease Treatments

    The US Food and Drug Administration (FDA) on Monday announced it is awarding $23 million in research grants for 21 new clinical trials over the next four years to boost the development of rare disease treatments. The grants, awarded to researchers from academia and industry at domestic and international clinical sites, are part of FDA’s Orphan Products Clinical Trials Grants Program, created in 1983, which has provided more than $370 million (including $19 million ...
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    FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry

    A new analysis published in The BMJ finds that more than a quarter of hematology and oncology drug reviewers at the US Food and Drug Administration (FDA) left the agency to work or consult for the biopharmaceutical industry between 2001 and 2010. "We are concerned by these findings," write Dr. Vinay Prasad and his colleague Dr. Jeffrey Bien at the Oregon Health & Science University, "The transition from regulator to advising companies seems logical but it raises questi...
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    FDA Issues New Guidance on Conflict of Interest for Advisory Committee Members

    The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest. FDA maintains around 50 advisory committees, comprised of experts from outside the agency, to weigh in on specific scientific and medical issues. These committees are typically convened when FDA wants input on a n...
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    FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest

    The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest. Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effective...
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    FDA Warns Monmouth Medical Center IRB Over Conflict of Interest Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document wh...
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    Public Health Advocates Worry EMA and Industry are Too Cozy

    A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry. Background Much like the US Food and Drug Administration (FDA), EMA receives much of its funding from fees it collects from industry for various services, such as application fees, scientific advice and pharmacovigilance fees. Generally, industry has been supportive of regulators charging fees for these services (although somet...
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    EMA to Close 'Revolving Door' Between Reviewers and Industry

    Members of scientific and expert committees at the European Medicines Agency (EMA) will no longer be able to take part in the evaluation of medicines if they intend to work for a pharmaceutical company. Background In 2012, EMA came under fire from the European Court of Auditors (ECA), after an audit uncovered a number of shortfalls in the agency's conflict of interest (COI) policies. At the time, ECA made recommendations to EMA intended to improve the agency's CO...
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    Conflicts of Interest on FDA's Advisory Committees Don't Matter Much, Paper Finds

    Conflicts of interest among members of the US Food and Drug Administration's (FDA) influential advisory committees don't have much of a practical impact on the outcome of voting decisions, new research argues. Background The paper comes as several research papers in recent years have made the opposite case—that advisory committee members with stated conflicts of interest do affect how a committee makes a decision. For example, a September 2014 paper in the journ...
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    European Medicines Regulators Put New Conflict-of-Interest Policy in Place

    The European Medicines Agency (EMA) has released a new conflict-of-interest policy it says is meant to take a more "balanced" approach to handling conflicts presented by its scientific committee members and experts it consults with. Background In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had  inadequately managed  situations involving conflict of interest (COI). "A number of shortcomings of varying degrees have been identified ...
  • EMA Tries to Clamp Down on Revolving Door of Regulators

    EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former leader. Background In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI). While those COIs spanned a wide number of areas, among the most critical identified was the ...
  • Does Advisory Committee Transparency Lead to Better Regulatory Decision Making?

    The US Food and Drug Administration (FDA) often courts controversy with its decisions to approve or deny new therapies. In the wake of some high-profile scandals in the past decade, the agency has made its regulatory processes more transparent by opening up its advisory committees to more public input and fewer potential conflicts of interest. But, until now, few have asked a simple question: Are those changes leading to improved regulatory outcomes? A new book, Regul...