On July 24, 2025, the Trump Administration turned to the U.S. Supreme Court to block U.S. District Judge Young’s preliminary injunction prohibiting the National Institutes of Health (NIH) from cutting hundreds of grant...more
The President’s Budget Request Impact on Programs for the Disabled and Older Americans Act Programs - This is part three of a series on health care budget cuts....more
THIS WEEK’S DOSE - - Reconciliation Moves Forward. Senate committees continue to release their reconciliation provisions. - NIH Director Testifies on FY 2026 Budget. National Institutes of Health (NIH) Director Bhattacharya...more
The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more
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
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
On May 2, 2025, the White House released President Trump’s recommendations for discretionary funding in 2026. These recommendations would result in “significant savings” and budget cuts to several healthcare programs. The May...more
U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more
Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...more
Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader...more
U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...more
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
New rounds of cuts and organizational shifts for HHS staff and operating divisions could dramatically impact the healthcare and life sciences industry....more
On March 27, 2025, HHS announced a downsizing and restructuring plan that combines personnel cuts, centralization of functions, and consolidation of HHS divisions. Among other things, the plan aims to cut the HHS workforce by...more
Senate Confirms FDA, NIH Nominations, Advances CMS Nomination. On March 25, 2025, the Senate confirmed Martin Makary, MD, as the next FDA commissioner by a 56 – 44 vote. Sens. Durbin (D-IL), Hassan (D-NH), and Shaheen (D-NH)...more
On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government...more
The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more
On February 13, the Senate approved Robert F. Kennedy Jr.’s nomination to serve as Secretary of Health and Human Services and the White House shortly thereafter issued an Executive Order establishing the Make America Healthy...more
RFK Jr. Confirmed as HHS Secretary. In a 52 – 48 Senate vote, Robert F. Kennedy (RFK) Jr. was confirmed as the next HHS secretary. All Democrats voted no, and Sen. McConnell (R-KY) was the only Republican to join them. He...more
Over the past few weeks, the Trump administration has introduced sweeping changes across the federal government that have impacted the federal grantee and contractor community. Adding to these changes, the National Institutes...more