FDA and Healthcare

William Vodra specializes in crisis management and regulatory issues involving the safety, effectiveness, quality, and marketing of medical products, including pharmaceuticals, biologicals, medical devices, and combinations products. He leads teams defending embattled products and represents companies in Food and Drug Administration (FDA) enforcement proceedings, white-collar criminal investigations, and civil litigation. He regularly counsels clients on approval strategies, product life cycle management, promotional practices, safety monitoring and reporting, and good manufacturing practice and quality systems. His work also includes dietary supplements, foods, and cosmetics. He is a frequent author and lecturer on FDA regulatory issues.

Prior to joining Arnold & Porter LLP, Mr. Vodra served as the Associate Chief Counsel for Drugs for FDA, and as Assistant Chief Counsel for DEA. He drafted many agency regulations still in use, including those implementing the Controlled Substances Act and FDA's rules for Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, bioequivalency and the Orange Book.

FDA and Healthcare Representative Matters

• Embattled products: Feldene (piroxicam) (1986-88); Versed (1987-89); Bjork-Shiley Heart Valve (1989-1994).
• FDA consent decrees: American Red Cross (1993); Abbott Laboratories (1999); Wyeth Laboratories (2000).
• Product liability: Feldene (1986-88); Bjork-Shiley Heart Valve (1989-94); diet drugs ("fen-phen") (1997-99); Rezulin (troglitizone (2000-01).
• Unfair competition litigation: the "Aspirin-Ibuprofen-Tylenol wars" (1979-87); Zyrtec-Claritin (1996-2001).