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Gregory Levine

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27 years of experience
Business Law
Washington, Washington, D.C., 1997

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Practice Area

Business Law

Additional Practice Area

Corporate

Jurisdictions Admitted to Practice

Washington
Since 1997

Washington, D.C., 1997

Professional Experience

Partner: Ropes & Gray; Current

: Current; 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 tothe 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 proceedingamong 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 whlstleblower 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

Education