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Washington, D.C.

Mark S. Brown

King & Spalding

ABOUT

Mark Brown is nationally recognized in Food & Drug Administration regulatory matters, civil litigation, criminal investigations and prosecutions, compliance matters and comprehensive risk assessments. Mark advises pharmaceutical, medical device and biotech companies, and pharmacies, on a broad range of FDA requirements and FDA regulatory issues that arise in products liability litigation and other disputes. A former Associate Chief Counsel for FDA, Mark is the Chair of the FDA and Life Sciences practice.

Mark has developed a national reputation for successfully resolving difficult and complex FDA compliance matters and enforcement actions. For pharmaceutical, medical device and food companies, and pharmacies, he has successfully negotiated and managed numerous complex consent decrees of injunction, successfully defended an injunction action brought by FDA, and persuaded the government not to bring enforcement actions in other civil and criminal matters.

Mark regularly counsels clients on drug safety issues, clinical trials, adverse event reporting, quality systems and manufacturing practices for drugs and devices. He also provides guidance concerning product failure investigations, factory inspections, recalls, product labeling, drug compounding, advertising, promotion, sales and marketing practices, and regularly advises clients on strategies for obtaining FDA approval and clearance for medical products.

Mark also handles FDA-related issues in product liability and commercial litigation. He was an architect of the preemption defense for both pharmaceutical and medical device clients, developing supporting evidence, briefing and arguing federal preemption motions in various federal and state courts.

Before joining the FDA, Mark was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission, where he concentrated on consumer fraud, healthcare advertising and promotional activities. He developed FTC enforcement actions against weight-loss centers, in vitro fertilization clinics and Northern Viriginia infertility doctor Cecil B. Jacobson, who was later convicted of defrauding patients.

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