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Department of Health and Human Services (HHS) Secretary of HHS Food and Drug Administration (FDA)

Paul Hastings LLP

Recent Investigations by the Texas Attorney General Piggyback on Federal ‘Make America Healthy Again’ Initiatives

Paul Hastings LLP on

Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - April 2025

Plutocrats reigned. The gulf between rich and poor was huge. Nativist extremists, populist politicians, and major elements of the media clamored about the waves of immigrants flooding into America. And health challenges...more

Venable LLP

Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry

Venable LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Foley Hoag LLP

Preparing for Impact: The Mifepristone Case in Texas Nears a Decision

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The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more

Foley Hoag LLP - Medicaid and the Law

Medicaid and the LawFoley Hoag LLP CMS Approves Two New Medicaid Waivers to Expand Coverage, Provide Flexibilities

On September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...more

Hogan Lovells

HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

Hogan Lovells on

On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more

Foley & Lardner LLP

OTC Hearing Aids: FDA Paves the Way in its Proposed Rule

Foley & Lardner LLP on

In response to President Biden’s Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed rule on...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Seyfarth Shaw LLP

HHS Advisory Opinion Concludes that the PREP Act Preempts Any State or Local Law that Prohibits Pharmacists from Administering...

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On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more

Bass, Berry & Sims PLC

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

Bass, Berry & Sims PLC on

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...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

Wilson Sonsini Goodrich & Rosati

FDA Prioritizes Review Generic Drug Products to Treat Opioid Overdose

Introduction: The Opioid Crisis - Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing,...more

Mintz - Health Care Viewpoints

Significant Drug Pricing Developments in July – Here’s What You Need To Know

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 #3

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Foley & Lardner LLP

Health Care Policy Newsletter - June 2018 pt 2

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more

Dorsey & Whitney LLP

FDA Chief and HHS Secretary Cite Prescription Drug Prices as Top Priorities for Agencies; President Trump Scheduled to Speak on...

Dorsey & Whitney LLP on

All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

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On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Baker Donelson

OIG Work Plan – October 2017 Update

Baker Donelson on

The OIG added five new items to its Work Plan with its October 2017 monthly update. This is a decrease from the nine new items added to the Work Plan with the September 2017 update. (For more information on last month's Work...more

Jones Day

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

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