Greg Levine is the counsel of choice for life sciences companies confronting their most consequential FDA challenges. Drawing on decades of experience, he steers pharmaceutical, biotechnology, and medical device manufacturers through every stage of the product lifecycle—designing regulatory strategies, securing marketing authorization, shaping labeling and promotional campaigns, responsibly addressing product safety issues, and handling FDA and related government agency inspections, investigations, and enforcement actions. Greg combines technical fluency with practical business judgment to offer advice and solutions that protect products, preserve reputations, and accelerate time to market.
The legal community recognizes Greg’s mastery of FDA law. Chambers USA ranks him in Band 1 among the nation’s leading attorneys for pharmaceuticals and medical products, and clients praise him as “an exceptional FDA attorney” and a “go-to resource.” He is also recognized in The Legal 500 United States Healthcare: Life Sciences Hall of Fame for FDA Law—affirming his status as a trusted strategist for industry-defining matters.
Prior to joining Ropes & Gray, Greg was a partner at an international law firm in Washington, D.C. and served on Capitol Hill as legislative staff in the U.S. House of Representatives, where he helped craft FDA-related legislation, policy, and appropriations. This rare combination of private-sector insight and legislative experience equips him to anticipate regulatory trends, influence policy, and secure favorable outcomes for clients operating at the intersection of science and law.
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.