News & Analysis as of

Controlled Substances Act Pharmaceutical Industry Department of Justice (DOJ)

Mintz - Health Care Viewpoints

EnforceMintz — Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024

In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more

Bass, Berry & Sims PLC

DOJ Brings Nationwide False Claims Act Lawsuit Against CVS for Alleged Violations of Controlled Substances Act

Bass, Berry & Sims PLC on

On December 13, the U.S. Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit alleging that CVS Pharmacy Inc. and its subsidiaries improperly sought federal reimbursement for prescriptions filled in...more

Woods Rogers

Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid

Woods Rogers on

Last week, the Department of Justice (DOJ) announced that Rite Aid, ten subsidiaries, and affiliate pharmacies agreed to settle allegations that Rite Aid violated the Controlled Substances Act (CSA) and the False Claims Act...more

Bass, Berry & Sims PLC

Rite Aid and OptumRx Settlements Highlight Enforcement Focus on Pharmacy Corresponding Responsibility for Dispensing Controlled...

Bass, Berry & Sims PLC on

On July 10, the Department of Justice (DOJ) announced a nearly $410 million settlement with Rite Aid Corporation to resolve allegations that Rite Aid and its affiliates ignored red flags and knowingly dispensed unlawful...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

Bass, Berry & Sims PLC on

Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

Husch Blackwell LLP

All the Outcomes of a Marijuana Reschedule

Husch Blackwell LLP on

Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...more

McGlinchey Stafford

DEA Likely to Reschedule Marijuana Based on Congressional Report

McGlinchey Stafford on

According to a report from the Congressional Research Service (the Report), the Drug Enforcement Administration (DEA) is likely to follow the Department of Health and Human Services (HHS) and the Food and Drug...more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

Vicente LLP on

On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

ArentFox Schiff

Investigations Newsletter: DOJ Files FCA Complaint Against Major Pharmacy Retailer Based on Alleged Violations of Controlled...

ArentFox Schiff on

DOJ Files FCA Complaint Against Major Pharmacy Retailer Based on Alleged Violations of Controlled Substances Act - On March 13, 2023, the Department of Justice (DOJ) announced that it filed a complaint in intervention...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

Oberheiden P.C.

U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals

Oberheiden P.C. on

On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Rules for Physicians in Blow to DOJ

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

Butler Snow LLP

Criminal Liability of Pharmaceutical Executives Under the Controlled Substances Act

Butler Snow LLP on

Civil lawsuits are an unavoidable and expected consequence of operating in a heavily regulated industry. While CEOs and other pharmaceutical executives may lose sleep over the outcome of civil trials and the potential...more

Fox Rothschild LLP

Enhanced Scrutiny of Opioid Prescriptions Poses Legal Risks for Medical Professionals

Fox Rothschild LLP on

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

Oberheiden P.C.

DOJ Opioid Enforcement Defense

Oberheiden P.C. on

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

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

McGuireWoods LLP

DEA Investigation Leads to Record-Setting Settlement for Drug Diversion at a Health Care System

McGuireWoods LLP on

The United States Department of Justice (DOJ) recently announced the nation’s largest settlement involving allegations of drug diversion at a health care system. The settlement, totaling $7,750,000, came after a years-long...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

The Volkov Law Group on

The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more

WilmerHale

Insys Ruling Casts Doubt on DOJ Opioid Investigations

WilmerHale on

On May 2, 2019, a jury sitting in the District of Massachusetts convicted five senior executives of Insys Therapeutics, Inc. (Insys) with racketeering conspiracy in violation of Title 18, United States Code, Section 1962(d)....more

Troutman Pepper Locke

DOJ Files Unprecedented Criminal Charges Against Opioid Distributor and Two Executives

Troutman Pepper Locke on

On April 23, federal prosecutors announced the first-ever felony charges against a drug distributor — Rochester Drug Co-Operative, Inc. (RDC) — and two of its executives for illegally distributing opioid painkillers....more

McDermott Will & Emery

DOJ Expands New Enforcement Tactic – Obtains TRO to Prevent Pharmacy From Dispensing Opioids

McDermott Will & Emery on

On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing...more

Mintz - Health Care Viewpoints

Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more

Burr & Forman

Burr Alert: Part II: White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

Burr & Forman on

In part one of this series, I detailed how the U.S. Department of Justice has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. See “Part One: DOJ Devotes Resources, Vows to Come...more

Burr & Forman

Burr Alert: Part I: White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

26 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide