King & Spalding’s FDA & Life Sciences Practice focuses on representing pharmaceutical, medical device, biotechnology and other healthcare technology companies, as well as food manufacturers, in a wide range of regulatory, compliance, policy, and litigation matters. Over 33 lawyers and non-lawyer professionals in our Washington, D.C., office provide sophisticated counseling and advice to more than 100 drug and device manufacturers and others in the healthcare technology sector, including nine of the 25 largest pharmaceutical manufacturers, and 18 of the 25 largest device manufacturers.

We represent manufacturers, health technology and food companies, distributors, and providers at every stage of product development and use, from early-stage regulatory and approval issues, to ongoing counseling on FDA, DEA, and healthcare compliance issues, to manufacturing and supply-chain management, to defense in civil and criminal government investigations, and to the development and implementation of comprehensive compliance programs in accordance with HHS Office of Inspector General guidelines, the U.S. Sentencing Commission Guidelines, and Sarbanes-Oxley requirements.

Members of our group have extensive governmental experience, having served with the FDA (five in the Chief Counsel's Office and one in the Center for Drug Evaluation and Research), Centers for Medicare and Medicaid Services, and the U.S. Department of Justice.

The FDA & Life Sciences Practice in Washington, DC is supplemented by our Atlanta-based Healthcare Industry Practice. Collectively, our team includes the former Assistant Attorney General, Criminal Division, U.S. Department of Justice, a former U.S. Attorney and several Assistant U.S. Attorneys from around the country, two former Special Counsel for Health Care Fraud at the U.S. Department of Justice, and a former compliance officer for an academic medical center.

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