Gregory H. Levine
Greg Levine, chair of the FDA regulatory practice group, focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices. Greg represents clients before state and federal regulators on all phases of the product lifecycle and is currently guiding clients through the development of laboratory diagnostics, therapeutics and vaccines related to COVID-19. In connection with the pandemic, he also counsels medical centers on emerging public health guidance. Greg regularly assists with both internal and government compliance investigations and enforcement actions. He also advises manufacturers of other FDA-regulated products, including cosmetics and dietary supplements, on a broad range of issues under the Food, Drug, and Cosmetic Act and related laws.
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.
- 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.
- 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.
- Co-author, “HHS Opinions Signal Broad Immunity From COVID-19 Liability,” Law360 (November 6, 2020)
- Quoted, “HHS Decision Raises Questions About Future Oversight of All LDTs,” Clinical Laboratory News (November 1, 2020)
- Co-author, “Questions Raised By FDA's New Lab Test Policy,” Law360 (October 20, 2020)
- Quoted, “Plans for Permanent Covid-19 Test Authorization in Works: FDA,” Bloomberg Law (October 16, 2020)
- Co-author, “HHS Lab Test Rule's Likely Impact During And After COVID-19,” Law360 (August 31, 2020)
- Co-author, “Analysis: FDA Response to COVID-19: A Shifting Landscape,” Ropes & Gray Alert (June 29, 2020)
- Co-author, “Pandemic May Spur Reform of Lab Test Regulation,” Law360 (April 7, 2020)
- Profiled, “How a Novel Virus Is Raising Novel Issues For Attorneys,” Law360 (March 17, 2020)
- Profiled, “FDA Focus: What Ropes & Gray’s Practice Chair is Watching,” Law360 (January 21, 2020)
- Co-author, “Kisor May Be A New Dawn For Challenges To FDA Actions,” Law360 (December 2, 2019)
- Quoted, “FDA Revises Clinical Decision Support Software Draft After Industry Blowback,” MedTech Dive (September 26, 2019)
- Co-authored, “Outsourcing Facilities Face Rising Drug Compounding Risks,” Law360 (September 18, 2019)
- Co-author, “A Guide To FCA Cooperation Credit For Life Sciences Companies,” Law360 (June 18, 2019)
- Co-author, “How FDA is Refreshing its Recall Readiness Guidance,” Law360 (May 29, 2019)
- Co-author, “What Fed. Circ. False Ad Ruling Means For Section 337 Claims,” Law360 (May 14, 2019)
- Co-author, “FDA Draft Guidance On Medical Device Inspections Is Limited,” Law360 (May 10, 2019)
- Co-author, “2018 FDA Enforcement Review: Drugs, Biologics And Devices,” Law360 (January 28, 2019)
- Co-author, “Insights On Right To Try Act And 'Expanded Access' Concerns,” Law360 (December 18, 2018)
- Co-author, “INSIGHT: The Right to Try Act and Its Implications for Pharmaceutical Manufacturers,” Bloomberg Law (July 24, 2018)
- Co-author, “FDA Clarifies Communication Rules for Medical Product Cos.,” Law360 (June 21, 2018)
- Co-author, “Lessons From FDA Draft Guidance On Multifunctional Devices,” Law360 (May 23, 2018)
- Quoted, “FDA Looks to Give Device Makers More Clearance Options,” Bloomberg Law’s Life Sciences Law & Industry Report (April 16, 2018)
- Co-author, “The Latest FDA Move To Limit Digital Health Software Regs,” Law360 (December 21, 2017)
- Co-author, “FDA Eases Burdens on Expanded Access Use,” Bloomberg BNA’s Medical Research Law & Policy Report (November 15, 2017)
- Co-author, “What to Know About New FDA Informed Consent Guidance,” Law360 (August 11, 2017)
- Co-author, “A Modern Approach to Digital Health Product Regulation,” Law360 (August 4, 2017)
- Quoted, “Focus on LDT Oversight Now Shifts to Congress,” Laboratory Economics (December 2016)
- Quoted, “Drug Industry May Face Less Scrutiny Under Trump,” Bloomberg BNA Health Care Daily Report (November 10, 2016)
- Quoted, “Certain Device Software Modifications Allowed Without Filing New 510 (k)s” FDA Week and Inside Health Policy (August 12, 2016)
- Quoted, “Device Makers Should Share Cyberthreat Info, Feds Say,” Bloomberg BNA Health Care Daily Report (January 21, 2016)
- Quoted, “Outlook 2016: Lab Tests, Cybersecurity, Off-Label Use Among Top Device Issues,” Bloomberg BNA Medical Devices Law & Industry Report (January 20, 2016)
- Quoted, “FDA Personalized Medicine Chief: Direct-to-Consumer Tests Are Not LDTs,” FDA Week and Inside Health Policy (December 18, 2015)
- Quoted, “FDA Targets More Firms Marketing Genetic Tests,” Bloomberg BNA’s Medical Devices Law & Industry Report (December 10, 2015)
- Co-Author, “Impact of Proposed Federal Research Regulation Amendments (the Common Rule NPRM) on Life Sciences Companies,” Bloomberg BNA Life Sciences Law & Industry Report (November 13, 2015)
- Quoted, “Pharmaceutical Companies Gird for Drug-Price Reckoning,” Institutional Investor, (October 8, 2015) (subscription required)
- Quoted, “E&C LDT Proposal Considered Progress, Language Concerning to Some,” FDA Week (July 2015)
- Quoted, “Device Tax Repeal, FDA’s Actions Affecting Industry Remain Top Issues,” Bloomberg BNA’s Medical Devices Law & Industry Report (January 21, 2015)
- Co-author, “Beware Of Malware: FDA On Cybersecurity Risks,” Law360 (July 1, 2013)
- Quoted, "FDA Warns Manufacturers and Providers: Medical Devices Vulnerable to Cyberattack," Bloomberg BNA’s Medical Devise Law & Industry Report (June 26, 2013)
- Quoted, “Senators' Draft Aims to Clarify FDA Role In Regulating Compounding Pharmacies,” Bloomberg BNA’s Health Care Daily Report (April 29, 2013)
- Quoted, "Attorneys, Device Company Officials Outline 2013 Liability Landscape for Device Makers," Bloomberg BNA Medical Devices & Industry Law Report (March 2013)
- Greg H. Levine, Eve Brunts, and Michele Garvin, "The Federal Payment Sunshine Law," U.S. News Best Lawyers 2011-2012 (November 2011)
- Speaker, “FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products,” Food and Drug Law Institute Webinar (April 14, 2020)
- Speaker, “FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS,” FDA Update – New England Biomedical Discussion Group & RAPS, MassMEDIC (December 11, 2018)
- Speaker, “Outlook 2018 Teleconference: The Trump Administration’s Impact on Life Sciences and Health Care—the First Year,” Ropes & Gray Teleconference (January 23, 2018)
- Speaker, “FDA Guidances and What Changes Are In Store for MedTech,” Advanced Medical Technology Association’s 8th Annual Advertising and Promotion of Medical Devices Conference (November 14, 2017)
- 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)
- JD, magna cum laude, Georgetown University Law Center, 1996
- AB, magna cum laude, Brown University, 1990