King & Spalding

King & Spalding advises pharma, biotech, and medical device companies on complex and high-stakes regulatory and enforcement matters across the product lifecycle. Based in Washington, DC, the team’s work spans clinical trials and product approvals through to post-market compliance, government investigations, and litigation. Clients regularly rely on the firm in sensitive DOJ and DEA inquiries, as well as in navigating False Claims Act litigation. Nikki Reeves, who co-chairs the government matters and regulation practice, advises life sciences companies on pre- and post-market FDA regulatory compliance and enforcement issues. John Shakow focuses on regulatory, commercial, investigative, and litigation matters relating to pharma pricing and reporting. Mark Brown, chair of the FDA and life sciences team, advises on FDA regulatory issues arising in product liability disputes and related matters. Lisa Dwyer develops regulatory, legislative, and litigation strategies for companies marketing FDA-regulated products, while Brian Bohnenkamp assists manufacturers with compliance programs and risk assessments.