FDAAA Leadership
General Counsel
Scott Danzis
Scott Danzis is a partner in the firm's Food & Drug and Health Care practice groups. From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration (FDA). While at FDA, Mr. Danzis was broadly involved in a wide range of legal and regulatory matters. Mr. Danzis advised agency officials on significant enforcement actions, legislative initiatives, and litigation. He also worked on key regulations and guidance documents and assisted in implementing provisions of the Food and Drug Administration Amendments Act of 2007.
Mr. Danzis regularly advises clients in the medical device, biotechnology, and pharmaceutical industries. He has substantial experience advising clients regarding FDA regulation of clinical trials, advertising and promotion, support for continuing medical education, drug and device labeling, imports and exports, good manufacturing practice, adverse event reporting, the Hatch Waxman Act, and the Freedom of Information Act. Mr. Danzis also counsels clients on compliance with federal antifraud statutes, including the federal anti-kickback statute, the federal False Claims Act, and the Medicaid drug rebate program.
Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.