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Stefanie A. Doebler

Partner

Washington +1 202 662 5271

  • About
  • Representative Matters
  • Credentials
  • About

    Stefanie Doebler is co-chair of the firm's Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Stefanie also advises on the development and implementation of health care compliance programs.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advice to trade association regarding implementation of the federal Sunshine Act and related advocacy before CMS; ongoing interaction with CMS on implementation issues.
    • Assistance to a pharmaceutical company regarding compliance with a corporate integrity agreement, including developing and implementing a comprehensive compliance program.
    • Advice on kickback and related issues associated with product support programs for a specialty pharmaceutical product.
    • Evaluation of the research activities of a large medical device company to identify high-risk initiatives.
    • Representation of major pharmaceutical company in criminal investigation under the FDCA regarding alleged off-label promotion.
    • Internal investigation for a pharmaceutical company regarding its publications policies and practices.

    Areas of Expertise

  • Credentials
    Education
    • University of Michigan Law School, J.D., 2004
        • cum laude
        • Michigan Law Review, Executive Note Editor
    • University of Michigan School of Public Health, M.P.H., 2004
    • Carnegie Mellon University, M.A., 1998
    • Northwestern University, B.A., 1997
        • with honors
    Bar Admissions
    • District of Columbia
    • Pennsylvania
    Judicial Clerkship
    • Hon. Ronald Lee Gilman, U.S. Court of Appeals, Sixth Circuit, 2004 - 2005
    Pro Bono
    • Representation of a local non-profit organization in legislative and regulatory efforts to ensure that the regional affiliate of a national insurance company fulfills its charitable health care obligation to the National Capital Area.
    • Assistance to dual-eligible individuals regarding their Medicare prescription drug benefits.
    Accolades
    • Washington DC Super Lawyers, FDA "Rising Star" (2014-2015)
    • Klepper Prize for Volunteer Excellence, Legal Aid Society of the District of Columbia (2014)

    Areas of Expertise

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