Kevin M. Madagan
Associate
- T:
- +1 202 414 9236 (Washington, D.C.)
- F:
- +1 202 414 9299 (Washington, D.C.)
- E:
- kmadagan@reedsmith.com
- Vcard
Kevin is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law. His practice encompasses a wide range of regulatory, litigation, corporate and contractual matters. Kevin works with numerous health care entities, including, pharmaceutical companies, medical device manufacturers, pharmacies, and health care providers (e.g., hospitals, skilled nursing facilities, rehabilitation facilities). In addition, Kevin has experience with FDA and USDA regulated food entities.
Kevin assists clients with marketing issues, product development, product launches, clinical trials, contract negotiation, importation issues, seizures, regulatory due diligence, regulatory filings, internal fraud and abuse investigations, corporate transactions, regulatory appeals (e.g., PRRB, DAB), and government inspections and investigations.
Kevin has extensive experience in FDA regulatory compliance and enforcement issues. He currently serves on an advertising and marketing committee that advises a large specialty pharmaceutical company.
Kevin is the deputy coordinator of the Pro Bono Committee of Reed Smith’s Washington office and is a member of the firmwide Pro Bono Committee.
Publications
- “Coming Soon! FDA’s Current Thinking on Social Media and Product Promotion,” Corporate Compliance Insights (June 7, 2010) (co-author)
- “FDA's Emerging Policy On Internet And Social Media Promotion Of FDA-Regulated Medical Products,” Health Lawyers Weekly, Vol. VII, Issue 47 (December 4, 2009) (co-author)
- “Prescription Drug and Medical Device Promotion—New FDA Draft Guidance On Presenting Risk Information” Health Lawyers Weekly, Vol. VII, Issue 24 (June 19, 2009) (co-author)
Speeches / Presentations
- “Regulation of Drug Manufacturing,” Food and Drug Law Institute, Introduction to Drug Law and Regulation (February 18, 2010)
- Co-presenter, "Food Industry Teleseminar Series: Part II - FDA / USDA / FTC Regulatory Issues," Reed Smith Client Teleseminar (February 11, 2009)
Experience
| 2006 | Reed Smith |
|---|---|
| 2005 | Kaiser Permanente - Intern, Legal Department |
| 2005 | U.S. Department of Health and Human Services, Office of the General Counsel, Centers for Medicare and Medicaid Services (CMS) Division - Legal Intern |
| 2005 | Professor Robin Fretwell Wilson - Research Assistant |
| 2004 | University of Maryland Child Welfare and AIDS Legal Clinic - Student Attorney |
| 2004 | Circuit Court for Baltimore County, Maryland - Judicial Intern |
Legal Education
| 2006 | J.D., University of Maryland School of Law, Concentration in Health Law Journal of Health Care Law & Policy - Manuscripts Editor (2005-2006), Staff Member (2004-2005) Maryland Association of Legislative Law Member Maryland Student Health Law Association Member |
|---|
Undergraduate Education
| 2000 | B.S., Virginia Polytechnic Institute and State University |
|---|
Professional Admissions / Qualifications
- Maryland
- District of Columbia
Professional Affiliations
- American Bar Association
- American Health Lawyers Association
- Food & Drug Law Institute
- Maryland Bar Association