News & Analysis as of

Administrative Procedure Act Department of Health and Human Services (HHS)

Orrick, Herrington & Sutcliffe LLP

District court partially grants defendants’ motions to dismiss, tosses Privacy Act claim

On April 16, the U.S. District Court for the District of Columbia granted in part and denied in part the defendants’ motion to dismiss a case involving claims that DOGE and several federal agencies (including the DOL, the...more

Ropes & Gray LLP

District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?

Ropes & Gray LLP on

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more

Brownstein Hyatt Farber Schreck

Reactions in the Wake of HHS Funding Cuts

In just over two months since President Donald Trump assumed office, the Department of Health and Human Services (HHS), now under the leadership of Secretary Robert F. Kennedy Jr., has undergone a profound shift in its...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

Baker Donelson on

Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

Orrick, Herrington & Sutcliffe LLP

District court receives sparring requests to deny DOGE access

On February 28, the Department of Labor, the CFPB, and the DHHS (the defendants), filed a motion to dismiss in the U.S. District Court for the District of Columbia, and a week later, a coalition of labor unions (the...more

Blank Rome LLP

60-Second Sustains: TISTA Science and Technology Corporation

Blank Rome LLP on

Protest of: TISTA Science and Technology Corporation - B-422891.2; .3; .4 - TISTA challenged the issuance of a task order by the National Institutes of Health to Tantus Technologies, alleging the agency engaged in...more

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Akerman LLP - Health Law Rx

No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking

The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...more

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

Maynard Nexsen on

On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

Alston & Bird

Trump Administration Changes Seek to Avoid Notice and Comment Hurdles

Alston & Bird on

Our Health Care and Health Care Litigation Groups examine a policy move by the Department of Health and Human Services (HHS) that will allow the department to forgo notice and comment procedures for many of its regulations....more

Holland & Knight LLP

HHS Publishes Notice About Policy on Adhering to Text of Administrative Procedure Act

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) on Feb. 28, 2025, issued a policy statement limiting the circumstances under which HHS agencies must publish proposed rules for public comment before the rules are...more

Morgan Lewis

HHS Rescinds Policy Extending Notice and Comment Rulemaking Procedures to Rules for Grants, Public Benefits, and Contracts

Morgan Lewis on

Effective March 3, 2025, the US Department of Health and Human Services (HHS) rescinded its long-standing policy that had waived a statutory exemption under the Administrative Procedure Act (APA) from notice and comment...more

Latham & Watkins LLP

HHS Issues Policy Statement to Expand Use of Rulemaking Without Notice and Comment

Latham & Watkins LLP on

The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

Holland & Knight LLP on

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

BakerHostetler

HHS Announces Policy To End Public Notice and Comment for Certain Future Proposed Rulemakings

BakerHostetler on

On March 3, the Federal Register published a policy statement from the Department of Health and Human Services (HHS) titled “Policy on Adhering to the Text of the Administrative Procedure Act” (the Policy Statement)....more

McGuireWoods Consulting

Department Of Health And Human Services Proposes Ending Public Comment For Grants And Contracts

On Feb. 28, 2025, the Federal Register listed a proposal to end mandatory public comment periods for the Department of Health and Human Services (HHS). This specifically relates to “agency management or personnel or to public...more

ArentFox Schiff

HHS Rescinds Richardson Waiver and Signals Reduced Opportunity for Public Comment on Agency Action

ArentFox Schiff on

On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to...more

Hogan Lovells

HHS rescinds policy regarding notice-and-comment rulemaking – implications for health care industry

Hogan Lovells on

On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more

McGuireWoods LLP

Fourth Circuit Upholds OIG Advisory Opinion Process

McGuireWoods LLP on

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

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