News & Analysis as of

Department of Health and Human Services (HHS) Regulatory Oversight Prescription Drugs

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

Venable LLP on

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more

McDermott Will & Schulte

This Week in 340B: February 4 – 10, 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

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

McDermott Will & Schulte

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more

McDermott Will & Schulte

Special Report: FDA 2019 Year in Review

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Troutman Pepper Locke

HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements

Troutman Pepper Locke on

U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more

Hogan Lovells

CMS proposes requiring drug prices in TV ads

Hogan Lovells on

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

Bricker Graydon LLP

340B litigation update: Both Ceiling Price Rule delay and 340B rate cuts face legal challenges

Bricker Graydon LLP on

On September 11, 2018, the American Hospital Association (AHA) and other major health care industry groups sued the Department of Health and Human Services (HHS), seeking to have the U.S. District Court for the District of...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

Robinson+Cole Data Privacy + Security Insider

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

13 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