WASHINGTON—Tom Cosgrove, who until last month was a senior official at FDA charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients, has rejoined Covington as a partner in its Food, Drug, and Device practice, resident in Washington.
Mr. Cosgrove held senior leadership positions within FDA’s Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. Mr. Cosgrove was responsible for setting FDA’s CGMP enforcement priorities and for clearing warning letters, import alerts, and referrals for civil and criminal enforcement. He also played a central role in agency deliberations concerning the approval of marketing applications submitted by companies with manufacturing compliance challenges.
As Acting Director of CDER Compliance in 2016, Mr. Cosgrove oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials, as well as bioequivalence studies. He resumed his role leading OMQ after his tenure as Acting Director ended.
Mr. Cosgrove first joined CDER in 2013 as the Director of the Office of Unapproved Drugs and Labeling Compliance. Before his time in CDER, Mr. Cosgrove was a litigator in FDA’s Office of Chief Counsel, handling a wide range of enforcement and defensive actions on behalf of FDA.
“Tom’s experience as a regulator, his outstanding reputation, and his pragmatic approach to problem solving will be a valuable asset to our clients in manufacturing and enforcement matters,” said Denise Esposito, co-chair of Covington’s Food, Drug, and Device practice. “In addition, Tom’s deep understanding of FDA’s complex requirements for pharmaceutical quality will serve as the perfect complement to our existing FDA regulatory practice, as we continue to strengthen our leadership in pharmaceutical and biotechnology manufacturing compliance.”
“I am tremendously excited to return to Covington,” said Mr. Cosgrove. “Covington’s stellar reputation for FDA regulatory work and collegial, collaborative culture is the ideal environment for me to resume my career in private practice.”
Prior to working at FDA, Mr. Cosgrove began his legal career as an associate in Covington’s Washington office. He graduated from the University of Michigan Law School magna cum laude, received a Master’s Degree in Clinical Psychology from New York University, and his undergraduate degree from Clark University.
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