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Regulatory Agenda Department of Health and Human Services (HHS)

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

McDermott+

McDermott+ Check-Up – July 25, 2025

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CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more

McDermott Will & Schulte

Bye-bye, bright dyes: Strategies for responding to FDA’s synthetic food dye phase-out

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

Morrison & Foerster LLP

FDA Publishes Post-Market Assessment Tool to Rank Chemicals in Food Supply

On June 18, 2025, FDA published a proposed “Post-Market Assessment Prioritization Tool” to guide how the agency plans to rank and prioritize food chemicals under its enhanced post-market review process. FDA’s unveiling of...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Regulators Pause Mental Health Parity Rules Enforcement

Federal regulators recently indicated they will not enforce parts of the final regulations issued in September 2024 under the Mental Health Parity and Addiction Equity Act (MHPAEA) and may soon propose new rules altogether....more

Latham & Watkins LLP

100 Days In: FDA Updates and Trends to Watch

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Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

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On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Hogan Lovells

HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers

Hogan Lovells on

Earlier this week, the Department of Health and Human Services (HHS) published a broad request for information (RFI) seeking input on how to “dramatically deregulate across all areas the Department touches.”1 It specifically...more

Holland & Knight LLP

HHS, FDA Issue Request for Information to Support Administration's Deregulatory Agenda

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The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social Media:...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

Ballard Spahr LLP

Mental Health Brake: 2024 MHPAEA Regulations Put on Hold

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A recent court filing offers a reprieve to health plan sponsors in their efforts to comply with final regulations issued last year under the Mental Health Parity and Addiction Equity Act (MHPAEA)....more

Venable LLP

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

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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

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Ervin Cohen & Jessup LLP

FDA and HHS to Phase Out Petroleum-Based Synthetic Dyes in Food

On April 22, 2025, the  U.S. Department of Health and Human Services (“HHS”) and U.S. Food and Drug Administration (“FDA”) announced new measures to phase out all petroleum-based synthetic dyes from the U.S. food supply....more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

Latham & Watkins LLP

Week 11 in Review: Wide-Ranging Tariffs, More Lawsuits, and Personnel Moves

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The Trump administration imposes additional wide-ranging tariffs as legal challenges to the administration’s actions continue....more

Skadden, Arps, Slate, Meagher & Flom LLP

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

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On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

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