News & Analysis as of

Enforcement Actions Public Health Pharmaceutical Industry

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

Cozen O'Connor

Bipartisan Coalition of AGs Secures $720 Million Settlement with Opioid Manufacturers

Cozen O'Connor on

Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more

Cozen O'Connor

All AGs Settle with Purdue Pharma over Opioid-Related Claims

Cozen O'Connor on

All 55 AGs from the states and territories have settled with Purdue Pharma, Inc., and its owners, members of the Sackler family, to resolve allegations related to the company’s role in fueling the opioid crisis....more

Arnall Golden Gregory LLP

OPDP is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more

Cozen O'Connor

Bipartisan AGs Urge FDA to Act Against Counterfeit GLP-1 Drugs

Cozen O'Connor on

The National Association of Attorneys General (NAAG) sent a letter on behalf of a bipartisan coalition of 38 state and territory AGs requesting that the FDA act to protect consumers from counterfeit forms of weight loss and...more

Cozen O'Connor

FDA Bans Red Dye No. 3 in Food and Ingested Drugs: What Manufacturers Should Know

Cozen O'Connor on

On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.1 Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18,...more

Cozen O'Connor

Purdue Pharma to Pay $7.4 Billion to Settle Thousands of Opioid-Related Lawsuits

Cozen O'Connor on

New York AG Letitia James, along with a bipartisan coalition of 15 other state AGs and additional parties, has reached a settlement in principle with members of the Sackler family and Purdue Pharma, Inc., to resolve...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

Quarles & Brady LLP on

This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

Console and Associates, P.C.

Some OTC Supplements Contain Tadalafil, According to the FDA

In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more

Robins Kaplan LLP

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

Robins Kaplan LLP on

Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Mintz - Health Care Viewpoints

New Government Action Aims to Increase Competition among Biological Products: FDA and FTC Step Up Industry Pressure

Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

K&L Gates LLP

DOJ’s Aggressive Effort to Combat Opioid Crisis Places Everyone in the Crosshairs

K&L Gates LLP on

INTRODUCTION - A wave of recent indictments unsealed against opioid distributors and their executives signifies that the U.S. Department of Justice (“DOJ”) has embarked on a criminal crackdown after years of civil...more

Bradley Arant Boult Cummings LLP

'Opioids and Legal Enforcement — A Primer' - HarrisMartin's Drugs & Medical Devices

The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more

Bradley Arant Boult Cummings LLP

Averting Government Scrutiny in the Wake of an Opioid Prescribing Crackdown - Practical Pain Management

The scourge of opioid-related addiction and risk is a well-known story among the pain management community. In response to this federally declared public health crisis, government prosecutors are upping their game. Almost...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more

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