Greg Levine, chair of the firm’s global FDA regulatory group, focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices. He provides advice, counsel, and representation before the FDA to leading pharmaceutical and medical device companies on their highest stakes matters and represents clients before state and federal regulators on all phases of the product lifecycle. Greg 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 and regularly assists FDA-regulated clients with both internal and government compliance investigations and enforcement actions.
Greg is ranked as a leading lawyer in the pharmaceutical and medical products field by Chambers USA. Clients describe him as “an exceptional FDA attorney” and a “go-to resource in this area.” His practical legal advice, sound judgment, and responsiveness also won him “Lawyer of the Year” for FDA Law in The Best Lawyers in America 2023. This award, given to one FDA attorney annually, reflects Greg’s wide recognition in the legal community as a top FDA law practitioner.
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.