News & Analysis as of

Regulatory Oversight Department of Health and Human Services (HHS) Government Agencies

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...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

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+

The Leaked OMB Passback Document: What It Is and Isn’t

McDermott+ on

Last week, a sensitive internal government document was leaked to the public: the White House Office of Management and Budget’s (OMB’s) passback to the US Department of Health and Human Services (HHS) laying out proposed...more

Stevens & Lee

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

Stevens & Lee on

On March 11, 2025, the U.S. Department of Health and Human Services (HHS) announced plans for a “reorganization of the Office of the General Counsel” (OGC) “[a]s part of the department’s ongoing efforts to advance the...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...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

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

BakerHostetler on

On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

Holland & Knight LLP

GAO Reviews Issues in Implementing and Reporting on the Buy American Act

Holland & Knight LLP on

The Government Accountability Office (GAO) recently published a report on the federal government implementation of the Buy American Act. The Buy American Act of 1933 is one of several statutes implementing a preference for...more

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