Jun

    REMS: Are the Federal Agencies Signaling Increased Scrutiny?

    1:30 PM EDT

    Curbing Risk Evaluation and Mitigation Strategies (REMS) abuses have been enforcement priorities for both Food and Drug Administration (FDA) and Federal Trade Commission (FTC). Both agencies want to ensure that the REMS program maintains its role in safeguarding the public and preventing potential abuse or diversion and are not used as a tool to delay or block potential generic competitors from entering the market. Representatives from government, private bar, and a think tank will discuss recent developments from FDA and FTC relating to curbing REMS abuses. The panel will also discuss private litigation activity relating to REMS abuses and possible legislative solutions.

    FREE:  Antitrust Section Members, Government, Non-profit Employees, Students.
    $25 Other Non-Members.

    Explore Section benefits or call 1-800-285-2221 to join. Code RAT14IP25.   For this and all upcoming events visit http://ambar.org/atevents.
     
    CLE
    The ABA is not seeking CLE credit for this program.

    Audio Archive: Provided all releases are obtained, MP3 recordings of this program will be available to Section members on the Committee Program Audio page.

     

     

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    REMS: Are the Federal Agencies Signaling Increased Scrutiny?

    Event Details

    Format

    Teleconference

    Date

    Jun 22, 2018

    2018-06-22T13:30:00-04:00 2018-06-22T14:45:00-04:00 REMS: Are the Federal Agencies Signaling Increased Scrutiny?

    Curbing Risk Evaluation and Mitigation Strategies (REMS) abuses have been enforcement priorities for both Food and Drug Administration (FDA) and Federal Trade Commission (FTC). Both agencies want to ensure that the REMS program maintains its role in safeguarding the public and preventing potential abuse or diversion and are not used as a tool to delay or block potential generic competitors from entering the market. Representatives from government, private bar, and a think tank will discuss recent developments from FDA and FTC relating to curbing REMS abuses. The panel will also discuss private litigation activity relating to REMS abuses and possible legislative solutions.

    FREE:  Antitrust Section Members, Government, Non-profit Employees, Students.
    $25 Other Non-Members.

    Explore Section benefits or call 1-800-285-2221 to join. Code RAT14IP25.   For this and all upcoming events visit http://ambar.org/atevents.
     
    CLE
    The ABA is not seeking CLE credit for this program.

    Audio Archive: Provided all releases are obtained, MP3 recordings of this program will be available to Section members on the Committee Program Audio page.

     

     

    Speakers

    Daniel Butrymowicz

    Federal Trade Commission

    Jeffrey Bank

    Wilson Sonsini et al

    Michael Kades

    Washington Center For Equitable Growth

    Sharon Coleman

    Food and Drug Administration

    Sponsors

    Health Care and Pharmaceuticals Committee

    Section of Antitrust Law

    Moderators

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