Michael Hacker advises companies on regulatory and commercial matters in connection with the manufacture and sale of drugs and vaccines. In particular, Mr. Hacker assists companies in responding to FDA enforcement actions, warning letters, inspections and in dealing with recalls. With more than 30 years of experience in the pharmaceutical industry, Mr. Hacker brings a wealth of knowledge to the representation of clients. Prior to joining the firm, he was vice president and assistant general counsel of Merck & Co., Inc.
During his career at Merck, Mr. Hacker had responsibility for the legal groups supporting several areas of Merck’s U.S. and international business, including manufacturing, quality, supply chain, procurement, facilities, environmental, health and safety, vaccines and animal health. Mr. Hacker was a trusted adviser to Merck senior management and senior staff on legal and business matters. He has significant experience in transactions, including divestitures and joint ventures, and in government investigations.