King & Spalding LLP

King & Spalding LLP represents clients in a range of complex disputes, including drug pricing issues under the federal 340B program, and is also a name to note for advice concerning the FDA’s regulatory procedures governing biologics and biosimilars. A number of investors in life sciences entities also regularly come to the firm for assistance in transactional matters. Leading the team is a three-person group of FDA regulatory specialists, with Mark Brown advising on both compliance and enforcement action, Nikki Reeves handling Form 483s and product recalls, and Seth Lundy, who assists medical device manufacturers design compliance programs and handle government investigations. Brian Bohnenkamp is also noted for his expertise in creating compliance programs, which he handles for both emerging and established players in the sector, while Lisa Dwyer specializes in the burgeoning digital health space, in addition to pre-market strategies. John Shakow is the name to note for issues of drug pricing, where he offers significant litigious experience. The practice was strengthened in August 2023 by the arrival from Hyman Phelps & McNamara, P.C. of Jeffrey Shapiro, an expert on the FDA’s approach to medical device regulation.