News & Analysis as of

Manufacturers Pharmaceutical Industry Enforcement

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

Gardner Law on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

ArentFox Schiff

The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court

ArentFox Schiff on

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

Sheppard Mullin Richter & Hampton LLP

FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas) for marketing...more

Sheppard Mullin Richter & Hampton LLP

OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more

Foley & Lardner LLP

One Year of Action Since President Biden’s Executive Order on Competition

Foley & Lardner LLP on

Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more

Womble Bond Dickinson

Opportunity Economy: Risks in Antitrust Enforcement

Womble Bond Dickinson on

Takeaways - ..The Biden administration’s recent executive order takes a hard line on limits to employment mobility, such as non-compete agreements. ..No-poach agreements—companies agreeing not to recruit each other’s...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Katten Muchin Rosenman LLP

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

Holland & Knight LLP

Legal Landscape and Guidance for Companies Involved in Marijuana Activity

Holland & Knight LLP on

Many states now permit the use of marijuana for medical or recreational purposes and the federal government has revised certain enforcement policies related to marijuana-related crimes. The possession, use,...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

12 Results
 / 
View per page
Page: of 1

"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