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Gregory H. Levine
Partner
Ropes & Gray
One Metro Center
700 12th Street, NW, Suite 900
Washington, DC 20005-3948
T + 1-202-508-4831
F + 1-202-383-9822
+ 1-202-508-4634 secretary
E-mail
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Practice
Greg Levine is a partner in Ropes & Gray's Washington D.C. office and co-chair of the firm's Life Sciences Practice Group. Greg focuses his practice on FDA regulation of pharmaceuticals, biotechnology, medical devices, and cosmetics. He also counsels pharmaceutical and medical device clients on compliance with health care fraud and abuse laws.
Professional Experience
A former legislative staff member in the U.S. House of Representatives and former member of a White House healthcare reform task force, Greg has extensive FDA experience. He regularly represents clients before state and federal regulators on all phases of product life cycle and assists clients with both internal and government compliance investigations and enforcement actions.
Greg's recent work includes counseling relating to the pre-approval promotion of biological products, 510(k) clearance for medical devices, FDA regulation of software, educational grant policies, clinical trials (Good Clinical Practices), clinical investigator disqualification, Good Manufacturing Practices, orphan drug exclusivity, pharmacy compounding, and product recalls across a range of FDA-regulated products. Additional representative matters follow:
Pharmaceuticals/Biotechnology
- Counseled a pharmaceutical manufacturer on drug exclusivity issues relating to a potential product acquisition
- Served as special regulatory counsel to a group of underwriters in an Initial Public Offering of a biotechnology company
- Advised a pharmaceutical manufacturer on orphan drug and pharmacy compounding issues potentially affecting a newly acquired product
- Represented a clinical investigator in a disqualification hearing before the FDA involving alleged violations of Good Clinical Practice requirements
- Led a due diligence team in assessing regulatory risks associated with the proposed purchase of a pharmaceutical product
- Assisted a pharmaceutical manufacturer in the negotiation, drafting, and implementation of a consent decree with FDA resulting from alleged violations of Good Manufacturing Practices
- Assisted a foreign pharmaceutical company in developing a strategy to minimize risks associated with country-to-country variations in informed consent documents in a multicenter, international clinical trial
- Counseled a biotechnology company on regulatory and ethical issues with respect to research use of leftover clinical samples from unrelated research
- Represented a university faculty member in negotiating a resolution of a disciplinary proceeding among a major university, the faculty member, and the Office of Human Research Protections within the Department of Health and Human Services
- Filed a petition on behalf of a pharmaceutical manufacturer urging the Drug Enforcement Agency (DEA) to schedule and regulate certain steroidal drugs
Medical Devices
- Represented a CLIA-regulated laboratory in an FDA inquiry to determine whether the company should be regulated as a manufacturer of In Vitro Diagnostic Multivariate Index Assays
- Counseled a medical device company on several international product recalls
- Assisted a device manufacturer in preparing a 510(k) submission and developing regulatory compliance policies for a new product
- Assisted several device manufacturers in responding to FDA "483s" (Notices of lnspectional Violations) and FDA Warning Letters involving alleged violations of FDA's Quality System Regulation and Medical Device Reporting requirements
- Developed and implemented a successful FDA strategy that helped a medical device manufacturer avoid adverse regulatory action due to an alleged product defect
- Aided a medical device manufacturer in developing a regulatory strategy for a new product line
Cosmetics
- Assisted a cosmetics manufacturer in developing regulatory strategy for product line using novel technology
- Provided counseling on marketing claims for a major cosmetics company
Health Care and Pharmaceutical Fraud, Abuse, and Compliance
- Led an internal investigation for a biotechnology client into a whistleblower complaint alleging violation of company promotional guidelines
- Drafted compliance manual covering fraud and abuse, pricing, and FDA regulatory compliance for a manufacturer of specialty pharmaceuticals
- Advised several pharmaceutical manufacturers on educational grants policies and assisted the companies in responding to congressional investigations into such policies. Developed recommendations for legal and business executives and assisted with the implementation of policies
Presentations & Speeches
- Moderator, "International/Import Safety Panel," Food and Drug Law Institute Annual Meeting, April 22, 2009
- "FDA Preemption of State Tort Liability Claims Involving Regulated Drugs and Medical Devices," West LegalEdcenter Webcast, July 16, 2008
- "FDA Regulation of Drug Marketing," FDLI Introduction to Drug Law and Regulation, Washington, D.C., June 27, 2008
- "New Drug Approval Process," American Conference Institute FDA Boot Camp, San Francisco, CA, May 29, 2008
Webcasts
- "Disclosure Issues and SEC Enforcement Trends in Connection with Clinical Trials and FDA Regulatory Communications,” with Patrick O'Brian and Dan O'Connor, April 14, 2009
- "The Preemption Decision of Wyeth v. Levine: Analysis and Impact on the Pharmaceutical Industry," with John Bueker and Howard Dorfman, March 19, 2009
- "The Government's Increasing Focus on Off-Label Promotion in CME." National CME Audioconference: Industry-Supported CME under Fire: Mitigating Risk and Enhancing Compliance, January 9, 2008
Professional & Civic Activities
- Editorial Advisory Board Member, BNA Medical Devices Law & Industry Report
Memberships & Affiliations
- Food and Drug Law Institute
Bar Admissions
Education
- 1996,
J.D., magna cum laude, Georgetown University Law Center
- 1990,
A.B., magna cum laude, Brown University
©2010 Ropes & Gray LLP. All rights reserved.
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