Gregory H. Levine

Partner

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  • JD, magna cum laude, Georgetown University Law Center, 1996
  • AB, magna cum laude, Brown University, 1990

Qualifications

  • District of Columbia, 1997
  • Food and Drug Law Institute
  • Advanced Medical Technology Association (AdvaMed)
  • Medical Device Manufacturers Association
  • Editorial Advisory Board Member, Law360 Life Sciences
  • Editorial Advisory Board Member, BNA Medical Devices Law & Industry Report
  • Legal 500 (2013-2017)
  • Who's Who Legal (2016)
  • LMG Life Sciences: “Life Sciences Star” (2013, 2016)
  • The International Who's Who of Life Sciences Lawyers (2012-2014)
  • The Best Lawyers in America (2011-2014, 2016-2018)
  • Chambers USA: America's Leading Lawyers for Business (2010-2017)
  • Washington, D.C. Super Lawyer (2012-2016)
  • PLC Which Lawyer? Yearbook: USA (2011)
  • “Legal Elite in Corporate Life Sciences and FDA Regulation” Smart CEO (2011)

Gregory H. Levine

Partner

Greg Levine, co-chair of the life sciences practice group, focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices. He also counsels his pharmaceutical and medical device clients on compliance with health care fraud and abuse laws. Greg regularly represents clients before state and federal regulators on all phases of product lifecycle and assists clients with both internal and government compliance investigations and enforcement actions.

Prior to joining Ropes & Gray, Greg was a partner at an international law firm in Washington, D.C. He is also a former legislative staff member in the U.S. House of Representatives, where he worked on FDA-related legislation, policy, and appropriations.

Experience

Pharmaceuticals/Biotechnology

  • Assisted a pharmaceutical manufacturer in responding to an FDA Warning Letter alleging violations of Good Clinical Practice regulations.
  • Assisted a pharmaceutical manufacturer negotiating, drafting, and implementing a Consent Decree of Permanent Injunction with FDA resulting from alleged violations of Good Manufacturing Practices.
  • Counseled a pharmaceutical manufacturer on FDA labeling and promotional issues relating to the use of new clinical data.

Medical Devices

  • Advised an in vitro diagnostic device manufacturer on 510(k) strategies.
  • Co-led an assessment of a device manufacturer’s promotional practices.
  • Assisted a device manufacturer in responding to an FDA Warning Letter alleging Quality System Regulation and Medical Device Reporting violations.

Health Care and Pharmaceutical Fraud, Abuse, and Compliance

  • Led an internal investigation for a pharmaceutical client into a whistleblower complaint alleging violation of company anti-kickback statute guidelines.
  • Drafted a compliance manual covering fraud and abuse, pricing, and FDA regulatory compliance for a manufacturer of specialty pharmaceuticals.
  • Advised a biotechnology company on its educational grants policies.

Publications

Presentations

  • Speaker, “21st Century Cures Act: Goals, Provisions, and Implementation Under the Trump Administration,” AHLA Webinar (March 2017)
  • Speaker, “Outlook 2017: The New Administration and Its Impact on Life Sciences and Health Care,” Ropes & Gray Teleconference (January 2017)
  • Speaker, “Potential Effects of 2016 Elections on Medical Device Industry”, FDA Update – New England Biomedical Discussion Group & RAPS, MassMEDIC (December 2016)
  • Speaker, “Enforcement, Litigation and Compliance,” Food and Drug Law Institute Conference (December 2015)
  • Speaker, “The Liability Landscape in 2013: Areas of Vulnerability and Exposure for Medical Device Manufacturers,” Medical Device Compliance, Regulation and Litigation Conference (March 2013)
  • Presenter, "Compliance Lessons Learned From Medical Devices," Pharmaceutical and Compliance Congress and Best Practices Forum (November 2011)
  • Moderator, "From Raw Materials to Finished Drug Products: Quality and Access are Key to Economic Success," Food and Drug Law Institute’s U.S.-China Food and Drug Law Conference (June 2011)
  • Presenter, “Research & Development and Clinical Trials: Good Clinical Practice Compliance: Avoiding the Mistakes That Can Derail Your Business,” 11th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (October 2010)
  • Presenter, “FDA Enforcement Trends and the Rebirth of the Responsible Corporate Officer Doctrine,” AdvaMedDx Board of Directors (July 2010)
  • Moderator, “The Reauthorization of FDA’s Prescription Drug User Fee Program and the Agency’s Use of Risk Evaluation and Mitigation Strategies (REMS),” Food and Drug Law Institute (May 2010)