News & Analysis as of

Department of Justice (DOJ) Warning Letters

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Troutman Pepper

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Troutman Pepper

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Nutter McClennen & Fish LLP

Nutter Bank Report: October 2023

The federal banking agencies have jointly issued a final rule that will modify how examiners assess compliance with the Community Reinvestment Act (CRA). Among other changes to the CRA regulations announced on October 24, the...more

Hinch Newman LLP

FTC Made in USA Lawyer Discusses Latest Agency Enforcement Matter

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A proposed FTC settlement that involves alleged false Made in USA representations and alleged deceptive COVID claims was recently filed by the Department of Justice on the FTC’s behalf against an individual and the two...more

Lighthouse

2021 Second Request Trends Report - A Look At HSR Second Requests In 2021 And What We Can Expect For 2022

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Federal agencies don’t publish official Second Request transaction numbers until late the following year. But recent trends suggest a high volume of activity for 2021 and 2022, as well as a stricter regulatory and political...more

White & Case LLP

Antitrust: Extended timelines and broader scope

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The Federal Trade Commission (FTC) was busy in its first year under the Biden administration. Over the past year, the FTC announced several important policy and process changes that may have significant implications for US...more

Vinson & Elkins LLP

2021 Energy and Chemicals Antitrust Report

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Antitrust activity increased significantly in 2021. This past year brought numerous changes in merger and non-merger enforcement policies and priorities that signal increased scrutiny in industry transactions. The “Biden...more

White & Case LLP

Federal Trade Commission’s Pre-Consummation Warning Letters Signal New Risk of Closing After Hart-Scott-Rodino Act Waiting Period...

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On Tuesday, August 3, 2021, the Federal Trade Commission announced a new approach for merger investigations that the FTC does not complete during the Hart-Scott-Rodino Act (HSR) waiting period—the FTC may advise merging...more

Seyfarth Shaw LLP

“Tidal Wave” of Merger Filings Prompts FTC To Send Pre-Consummation Warning Letters

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On February 4, 2021, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) announced that the agencies would temporarily suspend the practice of granting early termination of the 30 day waiting period in...more

Manatt, Phelps & Phillips, LLP

FTC Files First Case Under New COVID-19 Consumer Protection Act

The Federal Trade Commission (FTC) and the Department of Justice (DOJ) have filed the first case under the COVID-19 Consumer Protection Act, a law passed by Congress in December 2020 that imposes financial penalties on...more

Mintz - Health Care Viewpoints

FTC Engages in First Enforcement Action under COVID-19 Consumer Protection Act

In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19...more

Proskauer - The Capital Commitment

FinCEN Explains What Guides Its Enforcement Decisions

On August 18, 2020, the Financial Crimes Enforcement Network (FinCEN), which is the primary regulator and administrator of the Bank Secrecy Act (BSA), issued a statement on enforcement of the BSA. The requirements of the BSA...more

Morrison & Foerster LLP

How FDA Is Monitoring The COVID-19 Product Market

FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products,...more

Mintz - Health Care Viewpoints

FDA and FTC Continue to Trace and Fight Fraud Related to COVID-19

We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud. These agencies and their respective law enforcement efforts have yet to slow down and appear to have...more

Sheppard Mullin Richter & Hampton LLP

DOJ and FTC To Focus On Antitrust and Consumer Protection Violations Relating to Coronavirus

The rapidly evolving COVID-19 (coronavirus) situation is impacting local and global companies, disrupting supply chains, creating volatility in the stock market, and causing great concern in local communities. As part of the...more

Sheppard Mullin Richter & Hampton LLP

Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

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

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Arnall Golden Gregory LLP

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations

So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more

Manatt, Phelps & Phillips, LLP

Retail and Consumer Products Law Roundup - November 2015

We are pleased to share with you the first issue of Manatt's Retail and Consumer Products Law Roundup. The newsletter will be published on a monthly basis and will survey topics of critical importance to the retail,...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

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