Mark Brown is a partner in the firm’s FDA & Life Sciences Practice in Washington, D.C., and a former Associate Chief Counsel of the U.S. Food and Drug Administration (FDA). Mr. Brown’s practice focuses primarily on representing pharmaceutical, medical device, and biotech companies on a wide range of FDA regulatory matters, civil litigation, criminal investigations and prosecutions, internal investigations and compliance counseling, and comprehensive risk and compliance assessments. Mr. Brown has substantial expertise in drug safety issues, clinical trials, adverse event reporting, quality systems and manufacturing practices for drugs and devices, product failure investigations, factory inspections, recalls, product labeling, advertising, promotion, sales, and marketing practices. He also regularly advises clients on developing strategies for obtaining FDA approval and clearance for medical products.
Mr. Brown has more than 20 years of civil and criminal litigation experience and substantive regulatory expertise with the federal government and in private practice. During his tenure at FDA, he became one of the agency’s chief litigators handling both civil and criminal cases in the pharmaceutical and medical device area, particularly with respect to FDA’s current Good Manufacturing Practice/Quality Systems (“GMP/QSR”) regulations. Since joining King & Spalding in 1994, he has built a national reputation for successfully resolving difficult and complex FDA compliance and enforcement actions, having negotiated and managed several consent decrees of injunction both for pharmaceutical and medical device companies, and persuaded the government not to bring enforcement actions in several other matters.
Mr. Brown also has substantial experience in handling FDA issues in products liability and commercial litigation. For example, he has managed the preemption defense for both pharmaceutical and medical device clients, developing supporting evidence, preparing briefing, and arguing motions based on federal preemption in various federal and state courts. He is responsible for preparing fact and expert witnesses on FDA issues, and taking/defending depositions.
From 1999-2004, Mr. Brown served as the Hiring Partner in the Firm’s Washington, D.C., office. From 2005-2008, he served a co-chair of the FDA & Life Sciences practice. He has also served on the Firm’s Operating Committee and the Partners’ Committee.
During 1992, Mr. Brown served as a Special Assistant United States Attorney in the U.S. Attorney’s Office in Alexandria, Virginia where he defended the United States in a variety of civil actions, including federal tort claims, and assisted in criminal prosecutions.
Before joining FDA in 1990, Mr. Brown was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission where he concentrated on advertising and promotional activities in the healthcare area. He developed and handled the FTC’s civil fraud action against Dr. Cecil Jacobson, the Northern Virginia infertility specialist later convicted of defrauding his patients. Mr. Brown also developed FTC enforcement actions against in vitro fertilization clinics and weight loss centers.
Mr. Brown received his A.B. degree from the University of Michigan in 1982 where he was also a member of the Varsity Baseball team. Mr. Brown received his law degree from St. Louis University in 1985.
Awards & Recognition
- Recognized in Law & Politics “Washington, D.C. Super Lawyers,” 2007
- Recognized by Washingtonian Magazine’s as one of “Washington’s Best” Lawyers, 2004-2007
- Superior Achievement Award, Department of Health and Human Services
- FDA’s Commendable Service Award
