On May 12, 2025, the U.S. Department of Justice (DOJ) announced a major overhaul of its corporate enforcement policy, aiming to incentivize companies to voluntarily self-disclose misconduct. Titled “Focus, Fairness, and...more
Shortly after her confirmation, and just after her swearing-in by Associate Justice Clarence Thomas, U.S. Attorney General Pamela Bondi issued fourteen memoranda that seek to reform the Department of Justice by rescinding...more
DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
1/31/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Cannabis Products ,
Clinical Trials ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
Hart-Scott-Rodino Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Marijuana ,
Marketing ,
Medical Devices ,
Medical Marijuana ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B ,
Technology Sector ,
Telehealth ,
Telemedicine
In a significant development, the Department of Justice (DOJ) indicted 14 North Korean nationals on December 11, 2024 for their involvement in a sophisticated scheme to defraud U.S. companies and violate international...more
In an address this week to the Society of Corporate Compliance and Ethics, Principal Deputy Assistant Attorney General Nicole M. Argentieri of the Department of Justice’s (“DOJ”) Criminal Division, highlighted several updates...more
On August 22, 2024, the United States Department of Justice (DOJ) filed a Complaint-In-Intervention (the “Complaint”) against the Georgia Institute of Technology (Georgia Tech) and Georgia Tech Research Corp. (GTRC). The...more
On July 22, 2024, the Department of Treasury, Office of Foreign Assets Control (OFAC) announced a significant planned extension to its recordkeeping requirements, which will increase the retention period from five to ten...more
In 2019, the Department of Justice created the Procurement Collusion Strike Force (PCSF or Strike Force), a joint law enforcement effort to combat antitrust crimes and related fraudulent schemes that impact government...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
On December 14, 2023, with bipartisan support, Congress passed the Foreign Extortion Prevention Act (“FEPA”), making it a federal crime for any foreign government official to demand, receive, or agree to receive a bribe from...more
At the Global Investigations Review Annual Meeting in New York on September 21, 2023, Principal Associate Deputy Attorney General Marshall Miller (“Miller”) delivered remarks that provide an invaluable glimpse into the...more
9/26/2023
/ Acquisitions ,
Corporate Counsel ,
Corporate Crimes ,
Corporate Social Responsibility ,
Department of Justice (DOJ) ,
Enforcement Priorities ,
Mergers ,
National Security ,
Self-Disclosure Requirements ,
Transparency ,
Voluntary Disclosure ,
White Collar Crimes
In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws...more
The inattention some companies pay to their ethics and compliance program never ceases to surprise us. You’d think the frequency of DOJ press releases and prosecutions holding companies accountable for employee wrongdoing...more
On March 2, Deputy Assistant Attorney General Richard Powers laid out a significant and aggressive criminal enforcement agenda for the Antitrust Division of the Department of Justice. While speaking at the the ABA National...more
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters