Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Heath care fraud remains a top priority for the DOJ. This year’s National Health Care Fraud Takedown was the biggest in United States history, resulting in the prosecution of 324 defendants in connection with over $14.6...more
The Israel Competition Authority (ICA) conducted a thorough investigation of the S. Schestowitz Group, an Israeli company in the food and consumer goods sector, due to suspicions the company operated a cartel in the food...more
On December 13, 2024, the United States Attorney’s Offices for the Western District of Virginia and the District of Massachusetts, along with the Department of Justice’s (“DOJ”) Consumer Protection Branch (collectively, “the...more
At the mid-year point, 2024 is shaping up to be an eventful year in cartel enforcement. In the United States, the U.S. Department of Justice (DOJ)’s Antitrust Division (Division) enjoyed two significant victories and finally...more
The last post in this series explored the pattern of erectile dysfunction drugs being the most seized substance by INTERPOL along with the risks of corruption within the operation. Today’s post will explore the ways in which...more
The last post in this series described INTERPOL’s Operation Pangea and how law enforcement from varying countries use INTERPOL’s tools to share information and do cross-border investigations. Today’s post will discuss the...more
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
A growing problem in the U.S. is the widespread availability of counterfeit medications, or fake prescription pills. These drugs, made to look like authentic prescription medications, may contain no active ingredient or any...more
We always focus on foreign bribery — the FCPA and corporate bribery of foreign officials. It is certainly a problem that undermines economic development and human rights. ...more
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 U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with...more
The Controlled Substances Act (“CSA”) - The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
On December 9, 2020, the Japan Fair Trade Commission ("JFTC") brought criminal accusations with regard to bid-rigging involving pharmaceutical products ordered by the Japan Community Healthcare Organization ("JCHO"). Three...more
As COVID-19 continues to ravage the United States, the Department of Justice (DOJ) has recently announced its new National Rapid Response Strike Force within the Health Care Fraud Unit to investigate and prosecute fraud cases...more
The DOJ Antitrust Division’s multi-year criminal cartel investigation of the generic pharmaceutical industry is gaining steam. The latest company to settle is Taro Pharmaceuticals which agreed to enter a deferred prosecution...more
The Justice Department’s Antitrust Division announced a major guilty plea with Sandoz, Inc., in its expanding criminal investigation of the generic pharmaceutical industry....more
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more
Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system....more
A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more
In a record year, there are bound to be numerous interesting enforcement actions and principles. I picked out a few to highlight....more