News & Analysis as of

Proposed Rules Department of Health and Human Services (HHS)

Morrison & Foerster LLP

FDA and USDA Seek Comments on Defining Ultra-Processed Foods

On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published a joint Request for Information (RFI) to solicit information and data to help the agencies develop a...more

McDermott+

Healthcare Preview for the Week of: July 28, 2025

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Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more

Akin Gump Strauss Hauer & Feld LLP

FDA, HHS and USDA Serve Up Ultra-Processed Food RFI

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request...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

Holland & Knight LLP

Holland & Knight Health Dose: July 22, 2025

Holland & Knight LLP on

With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more

McDermott+

McDermott+ Check-Up – July 18, 2025

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THIS WEEK’S DOSE - - OBBBA implementation begins. While the administration focuses on implementing the new law, some lawmakers are already discussing adjustments to health provisions in the One Big Beautiful Bill Act...more

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...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

Alston & Bird

Health Care Week in Review | Senate HELP Committee Releases Budget Reconciliation Text; White House Issues Memo on Medicaid State...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Cozen O'Connor

FDA’s New Measures to Eliminate All Petroleum-Based Synthetic Dyes from Food

Cozen O'Connor on

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a plan to phase out all petroleum-based synthetic dyes from the nation’s food supply. The plan is...more

McDermott+

McDermott+ Check-Up: June 6, 2025

McDermott+ on

THIS WEEK’S DOSE - - Senate Begins Work on Reconciliation. Democrats prepared to file points of order to exclude certain provisions under the Byrd rule, while Republicans discussed key health provisions. - White House Sends...more

Sheppard Mullin Richter & Hampton LLP

Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Mayer Brown

HHS and FDA Announce Plans to Phase out Synthetic Food Dyes

Mayer Brown on

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a series of steps intended to eliminate all petroleum-based synthetic dyes from the US food...more

Polsinelli

The Trump Administration Announces Price Targets as It Takes a Second Swing at “Most Favored Nation” Drug Pricing Model

Polsinelli on

At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more

Hogan Lovells

FDA Announces Plans for Post-Market Chemical Review Program

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more

McDermott+

McDermott+ Check-Up: May 16, 2025

McDermott+ on

THIS WEEK’S DOSE - - Key House Health Committees Advance Reconciliation, Bill Held Up in Budget Committee. The Energy and Commerce Committee and Ways and Means Committee passed their recommendations for reconciliation out of...more

Hogan Lovells

HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

Hogan Lovells on

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

Hogan Lovells

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

Hogan Lovells on

On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

King & Spalding on

On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

Morrison & Foerster LLP

So Long, CPSC?

The Trump administration may eliminate the Consumer Product Safety Commission (CPSC), according to a recently leaked draft fiscal year 2026 budget for the Department of Health and Human Services (HHS). This “pre-decisional”...more

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