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King & Spalding LLP

1700 PENNSYLVANIA AVENUE, NW, WASHINGTON, DC 20006, USA
Tel:
Work +1 202 737 0500
Fax:
Fax +1 202 626 3737
Web:
www.kslaw.com

Mark Brown

Tel:
Work +1 202 626 5443
Email:
King & Spalding LLP

Position

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.

Career

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/Healthcare practice. He has also served on the Firm’s Operating Committee and the Partners’ Committee. During 1992-1993, Mr. Brown served six months 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.

Education

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.


United States: Industry focus

Healthcare: life sciences

Within: Healthcare: life sciences

The ‘highly pragmatic and commercial’ firm King & Spalding LLP is particularly praised by clients for its ‘strong IP expertise’ and its ‘keen understanding of how FDA works’. The  life sciences practice is co-headed by Nikki Reeves, Mark Brown and Seth Lundy. Reeves and Atlanta’s Andy Bayman successfully defended Vertical Pharmaceuticals and BioDelivery Sciences International (BDSI) in a lawsuit filed by the State of Arkansas and various Arkansas counties and cities, which aimed at recouping the public health costs associated with the abuse of opioid analgesics allegedly marketed and distributed by the clients in the State. Other clients include Medtronic and Boehringer. With her ‘unending enthusiasm to take on clients’ causes as her own’, former FDA’s Lisa Dwyer ‘stands above the crowd’. David Farber, who ‘comes to the table with years of developed wisdom in the pharma space’, Preeya Noronha Pinto and Jessica Ringel are also recommended. The ‘unique team’ of patent litigators Gerald Flattmann, Evan Diamond and Vanessa Yen joined the New York office from Paul Hastings LLP in July 2018. Stephen Abreu left to Sidley Austin LLP. Names of individuals are based in Washington DC unless otherwise indicated.

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