The ECCP is intended to assist federal prosecutors in determining whether a corporation’s compliance program was effective at the time of the alleged offense(s) and, if not, what type of enforcement, monetary penalty, and...more
Continuing the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) efforts to bolster enforcement and compliance, on April 18, 2023, BIS issued a memorandum announcing significant changes to its voluntary...more
Key Takeaways-
•On March 1, 2023, the Assistant Attorney General (“AAG”) for the Criminal Division of the U.S. Department of Justice (“DOJ”), Kenneth A. Polite, Jr., issued a revised memorandum on the imposition and...more
On March 3, 2023, the Criminal Division of the U.S. Department of Justice ("DOJ") revised its Evaluation of Corporate Compliance Programs or ECCP (the “March 2023 ECCP”) for the first time since June 2020....more
On January 17, 2023, the Assistant Attorney General (AAG) for the Criminal Division of the U.S. Department of Justice (DOJ), Kenneth Polite, Jr., announced that DOJ had made “significant changes” to its Corporate Enforcement...more
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more
11/16/2022
/ Biotechnology ,
Clinical Trials ,
Criminal Investigations ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Data ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences
Recent scrutiny of interlocking directorates – when a person serves as an officer or board director of two competing corporations – by the U.S. Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission...more
On September 28, 2022, the Assistant Attorney General for the Criminal Division of the United States Department of Justice (DOJ) joined the Inspector General for the United States Department of Health and Human Services...more
Speaking at a Compliance Week event on May 17, 2022, Assistant Attorney General (“AAG”) Kenneth Polite reaffirmed that companies that “take compliance seriously” can expect a reduced likelihood that investigators will impose...more