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Enforcement Prescription Drugs

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

McGuireWoods LLP

Pharmacist Has Key Role in Assessing “Legitimate Medical Purpose” of Controlled Substance Prescriptions

McGuireWoods LLP on

Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional...more

Robinson+Cole Health Law Diagnosis

False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases

The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government...more

Goodwin

State Drug Transparency Laws - 2025 Update

Goodwin on

We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

McDermott Will & Schulte

HHS OIG Releases Updated Nursing Facility Compliance Program Guidance: Quality and Safety Lessons

Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more

McDermott Will & Schulte

This Week in 340B: January 14 – 20, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

Foley & Lardner LLP

GLP-1 Drugs: FDA “Re-Confirms” Decision Removing Tirzepatide from the Drug Shortage List

Foley & Lardner LLP on

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

ArentFox Schiff on

Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

Fenwick & West LLP

Heart of Healthcare Podcast: FTC Chair Lina Khan on Healthcare, Antitrust, and the Future of Competition

Fenwick & West LLP on

In a recent episode of the Heart of Healthcare podcast, co-hosts Michael T. Esquivel and Halle Tecco, sat down with Federal Trade Commission (FTC) Chair Lina Khan, who offered her perspective on the intersection of antitrust...more

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

Foley Hoag LLP

Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

Foley Hoag LLP on

Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

King & Spalding

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

King & Spalding on

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Mintz - Health Care Viewpoints

House Committee Proposes to Extend Medicare Telehealth Flexibilities, Eyes PBM Reform to Offset Expenses

On May 8, 2024, the U.S. House of Representatives Ways & Means Committee passed a bipartisan bill entitled the “Preserving Telehealth, Hospital and Ambulance Access Act” by a vote of 41-0, which will potentially have...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

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Snell & Wilmer

Enforcement Back On: Departments Rescind Enforcement Relief for Machine Readable File Requirements under Transparency in Coverage...

Snell & Wilmer on

On September 27th, the Departments released FAQs about Affordable Care Act Implementation Part 61 (“FAQ 61”), announcing that the Departments are rescinding prior-issued enforcement relief for certain machine-readable file...more

Arnall Golden Gregory LLP

What Would Al Stewart Think About OPDP’s Latest Untitled Letter: A Sign of More Enforcement?

In his 1973 song, “Nostradamus,” singer-songwriter Al Stewart sang, “I am the eyes of Nostradamus, all your ways are known to me.” So, we started thinking, what would Mr. Stewart think of FDA’s Office of Prescription Drug...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Gardner Law

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

Gardner Law on

The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more

Gardner Law

Whose Data Breach Is It Anyway?

Gardner Law on

To set the stage, it is important we review the current privacy and cybersecurity landscape. New privacy laws and regulations are emerging at both the state and federal levels, not to mention internationally, imposing...more

Holland & Hart - Health Law Blog

Idaho’s New Virtual Care [Telehealth] Access Act

Idaho’s new Virtual Care Access Act (the “Act”) amends Idaho’s existing law to make it easier to render telehealth in Idaho effective July 1, 2023. The requirements of the new Act are summarized below....more

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