FDA Regulatory and Enforcement Attorney Karen Corallo Joins Skadden

Skadden is pleased to announce that Karen C. Corallo, a former director at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), has joined the firm’s health care litigation and enforcement practice as of counsel in the Washington, D.C. office. Ms. Corallo, who joins Skadden from another major law firm, advises pharmaceutical, medical device and food industry clients in litigation and counsels businesses on administrative, regulatory and enforcement matters.

As director of CDER’s Division of Drug Imports, Exports, Recalls and Shortages, Ms. Corallo wrote and executed the FDA’s global drug imports strategy, directed key drug policy initiatives, collaborated with key personnel across all centers on core agency initiatives, managed operations, and supervised agency staff. Ms. Corallo also previously served as associate chief counsel in the FDA’s Office of Chief Counsel, where she handled both civil and criminal enforcement across all FDA-regulated commodities. She was the first FDA attorney fully dedicated to the Health Care Fraud and Abuse Control Program under the joint direction of the attorney general and the secretary of the Department of Health and Human Services. In that program, Ms. Corallo worked with the Department of Justice Consumer Protection Branch and U.S. Attorneys’ offices across the country on matters involving manufacturing quality, clinical trial fraud, and marketing and promotional enforcement issues.

“We are thrilled to welcome Karen to the firm,” said Mitchell Ettinger, head of Skadden’s Washington, D.C. office. “Her experience advising on critical FDA regulatory and enforcement issues, both from within the FDA and in private practice, will be of tremendous value to our clients as health care regulations and enforcement activities continue to evolve.”

“I am excited to work alongside the unparalleled team of health care litigation and enforcement attorneys at Skadden,” said Ms. Corallo. “The firm’s reputation for handling complex, high-stakes enforcement matters and navigating unprecedented regulatory challenges on behalf of its clients is unmatched in this industry.”

Prior to joining the FDA, Ms. Corallo was a partner in the litigation group at another global law firm. She received her J.D. with highest honors from South Texas College of Law and her B.A., summa cum laude, Phi Beta Kappa, from the University of Texas, Austin.