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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Auditors Hit EMA for Failing to Meet Conflict of Interest Standards

    • 12 October 2012
    Auditors with the European Court of Auditors (ECA) have determined that the European Medicines Agency (EMA), despite its attempts to increase transparency and implement conflict-of-interest (COI) policies, is falling short of its responsibilities to, "Adequately manage COI situations." "A number of shortcomings of varying degrees have been identified in Agency-specific policies and procedures as well as their implementation," ECA wrote. "After examining the situation...
  • Bill Delaying Transparency Measures Passed Into Law

    US legislators have delayed the implementation of legislation that would have required dozens of high-ranking officials at the US Food and Drug Administration and other federal agencies to disclose potentially dangerous personal information. The act, known as the Stop Trading on Congressional Knowledge (STOCK) Act was originally brought up by legislators after a CBS 60 Minutes investigation suggested some members of Congress were using insider information to ...
  • Top FDA Officials' Financial Records Could Soon be Made Publicly Available

    Tens of thousands of high-level staff members at all federal agencies, including hundreds at the US Food and Drug Administration (FDA), will soon be required to publicly disclose their financial information under the terms of a recently passed piece of legislation known as the Stop Trading on Congressional Knowledge (STOCK) Act , reports The Washington Post . But the impending deadline has more than a few federal officials, including numerous scientists , cryi...
  • EMA's Rasi Moves to Streamline Conflict of Interest Policies at EMA

    The European Medicines Agency (EMA) has released an updated procedure governing how the agency's employees are investigated for any potential conflicts of interest (COI) relative to their duties reviewing medicinal products. The standard operating procedure (SOP), Conducting checks for conflicts of interest of Agency employees assigned duties relating to medicinal products for human or veterinary use , was approved by EMA Executive Director Guido Rasi on 23 March 2012...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • EMA Strengthens Conflict of Interest Policies

    The European Medicines Agency (EMA) announced Monday, 26 March its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies surrounding its scientific committee members and experts. The Management Board also adopted several other initiatives, including a transparency initiative to "increase the transparency of all pharmacovigilance activities of the Agency and national authorities" while implementing the ...
  • New Guidance on Conflict of Interest Disclosures for Advisory Committees

    The US Food and Drug Administration (FDA) released new draft guidance on 8 March about the availability of conflict of interest information and waiver information for members of advisory committees. The guidance also establishes a procedure for disclosing financial interest and granting conflict-of-interest (COI) waivers to special Government employees (SGEs) and regular employees. The guidance also provides a standardized mechanism for public disclosure of such document...