Neeraj Pai is counsel in Sidley Austin’s Food, Drug and Medical Device Compliance and Enforcement practice. His practice focuses on representing life science companies in connection with government investigations, enforcement proceedings, and litigation. These investigations and enforcement proceedings involve a range of matters including marketing practices, product safety and reporting, good manufacturing practices, and civil and criminal violations of the Federal Food, Drug, and Cosmetic Act (the “FDCA”).
Prior to joining Sidley, Mr. Pai worked in the FDA’s Office of Chief Counsel from 2008 to 2012. During his tenure, he worked closely with the FDA’s Office of Criminal Investigations (OCI), the Department of Justice, and other federal agencies responsible for investigating, prosecuting, and resolving criminal enforcement actions and related civil False Claims Act cases involving drugs, medical devices, and biological products. Mr. Pai has experience handling cases involving a wide array of issues, including marketing and promotional activities, reporting obligations, import issues, unapproved new drugs, adulterated food products, reporting requirements, smuggling, and fraud.
During his time at FDA, Mr. Pai was appointed as a Special Assistant United States Attorney by the Department of Justice, and assisted in the indictment and successful prosecution of cases at both the federal and state level involving adulterated and misbranded foods, drugs, devices, dietary supplements, and cosmetics. These cases included both felony and misdemeanor prosecutions under the FDCA. Mr. Pai also worked closely with field agents from OCI, the Federal Bureau of Investigation, U.S. Immigrations and Customs Enforcement, and other federal and state law enforcement agencies during the course of criminal investigations. In addition, Mr. Pai developed training materials and taught courses on food and drug law to OCI Agents.
Before entering government, Mr. Pai worked in private practice in Washington, D.C., representing individuals and Fortune 500 corporations in a variety of matters, with a focus on tax controversy, transfer pricing, government investigations, and internal investigations.
J.D., Harvard Law School (1999)
B.S., Villanova University (1996) magna cum laude
Bloomberg BNA Tax Management Portfolios:
626 T.M., Obtaining Information from the Government in Discovery and Disclosure-Related Damages Actions Against the Government (co-author)
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