Toni Citera is a solution-driven, client-focused lawyer and global leader with significant legal and compliance experience in the pharmaceutical, biotech, and health care industries. Toni has a strong record of partnering with clients to achieve results and mitigate risk. She has more than 23 years of experience representing and counseling companies in high-stakes civil and criminal investigations and litigations.
Prior to rejoining Jones Day in 2020, Toni served as Senior Vice President, Chief Compliance and Risk Officer for Celgene Corporation, a global pharmaceutical company, where she sat on the Executive Committee of the company and reported directly to the CEO and the board's Audit Committee. Toni was responsible for, among other things, health care and good practice (GxP) compliance for U.S. and international markets, internal investigations, enterprise risk management, training and communication, monitoring, and privacy. She also advised the company on new product launches, including for novel therapies such as CAR-T cancer treatment, and on pertinent legal issues, including a congressional pricing investigation. Toni assisted with Bristol Myers Squibb's acquisition and integration of Celgene in 2019 and the divestiture of a key biotechnology product to Amgen.
Toni has litigated and counseled clients in matters involving the False Claims Act (FCA); Anti-Kickback Statute (AKS); Food, Drug, and Cosmetic Act (FD&C); Racketeer Influenced and Corrupt Organizations Act (RICO); Foreign Corrupt Practices Act (FCPA); and fraud allegations related to issues such as pricing, off-label marketing, kickbacks, bribes, Medicaid rebates, and pharmacy benefit manager (PBM) relationships. Her representations include securing favorable settlements and no corporate integrity agreements in investigations and litigation involving several pharmaceutical companies, including Celgene and Abbott Laboratories.
Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending
Third Circuit Rejects False Claims Act Theory that Anti-Kickback Violations "Taint" All Related Claims
Third Circuit Confirms Government Knowledge Can Defeat Scienter and Materiality Requirements for False Claims Act Liability
- June 2020
DOJ Updates Its "Evaluation of Corporate Compliance Programs" Guidance
- March 28, 2012
Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities: The Impact on Clinical Research Sites
- March 28, 2012
Healthcare 2012: Issues & Answers For A Complex Industry
- June 29, 2011
Roundtable on Designing and Implementing Compliance Systems in a Whistleblower and Bounty Hunter World, NYU Center for Labor and Employment Law
Speaking Engagement Prior to Rejoining Jones Day
May 6, 2019
Law & Economics Symposium, The future of False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases, MIT Sloan School of Management
- Northwestern University (J.D. 1996; Coordinating Note and Comment Editor, Journal of Criminal Law and Criminology); Syracuse University (B.A. with honors 1993)
- New York, U.S. Court of Appeals for the Second Circuit, and U.S. District Courts for the Southern and Eastern Districts of New York
- 2015 Flex Success Award from the Diversity & Flexibility Alliance