RAJ PAI is a partner and global leader of the Food, Drug and Medical Device Compliance and Enforcement group. 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), as well as violations of the False Claims Act.
Examples of Raj’s representative matters include:
- Representing a multinational pharmaceutical company in a criminal and civil data integrity and GMP investigation involving an Indian manufacturing site.
- Advising a global pharmaceutical manufacturer on compliance with a Consent Decree involving GMP and data integrity obligations.
- Providing on-site guidance to global and domestic pharmaceutical and medical device companies in preparation for FDA inspections.
- Working with pharmaceutical and medical device manufacturers to help them respond to FDA Form 483s, Warning Letters, and Untitled Letters, as well as develop site remediation work plans.
- Advising life sciences companies in connection with interpretation of FDA Emergency Use Authorizations related to the COVID-19 pandemic.
- Advising companies in connection with pharmacovigilance issues, including preparation for pharmacovigilance inspections by regulatory authorities.
- Advising companies in connection with interpretation of FDA’s combination product regulations and related enforcement issues.
- Represented a global pharmaceutical company in negotiations with FDA to partially lift a Consent Decree, leading to agreement with FDA and Department of Justice to lift the Decree across multiple manufacturing sites.
- Represented a U.S. biopharmaceutical company in a criminal investigation involving alleged GMP violations and false statements, resulting in a Department of Justice (DOJ) declination to prosecute.
- Advised U.S. aseptic pharmaceutical manufacturers on Quality Assurance systems and compliance.
- Represented a global pharmaceutical company in an internal investigation and disclosure to FDA concerning alleged laboratory data integrity violations at a foreign manufacturing facility.
- Conducted multiple internal investigations of data integrity issues at client manufacturing sites.
- Advised a global medical device manufacturer in connection with a recall, third party review of supplier programs, and internal investigation.
Prior to joining Sidley, Raj 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. Raj 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, Raj 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. Raj 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, Raj developed training materials and taught courses on food and drug law to OCI Agents.
Before entering government, Raj 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.