Organizations challenging an agency’s termination of a grant or government contract based on an allegedly illegal government policy need to master a two-step dance, according to a recent U.S. Supreme Court decision. Under the...more
On July 23, the White House released its strategic action plan on AI, “Winning the Race: America’s AI Action Plan” (the AI Action Plan), which is designed to secure U.S. global leadership in AI with a strategic focus on...more
On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). 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
WHAT: A Massachusetts federal judge blocked the National Institutes of Health (NIH) from cutting hundreds of programs that provide grants to universities, hospitals, and other organizations. The judge found that NIH offered...more
THIS WEEK’S DOSE - - Senate Finance Committee Releases Reconciliation Text. The language is subject to change as negotiations continue and the Byrd rule process plays out. - CMS Releases MA Risk Adjustment Audit Methodology...more
On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more
This is part two of a series on health care budget cuts. The President’s Budget Requests Dramatically Reduce Biomedical Research - The president’s budget request was a major disappointment to those interested in...more
On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more
McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. June 5, 2025 – On May 30, 2025, the US Department of Health and Human Services...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
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
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
The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more
A group of 16 Democratic AGs, led by Massachusetts AG Andrea Joy Campbell, filed a lawsuit alleging that the National Institute of Health’s (NIH) delays in the review and approval of grant applications and terminations of...more
Last week, the US Department of Health and Human Services (HHS) announced that it will undergo a major restructuring and plans to eliminate 10,000 employees on top of 10,000 HHS employees who have already departed (20,000...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
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
On March 5, 2025, Judge Angel Kelley, a federal district court judge sitting in Massachusetts, granted a nationwide preliminary injunction which serves to temporarily block the Trump Administration’s attempt to cap the...more
Our Government Contracts Group examines how companies can prepare for the Trump Administration’s Rate Change Notice despite the uncertainty of the temporary restraining order that put it on hold....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
The incoming Trump administration has sent many signals that it intends to ramp up the Department of Defense’s use of nontraditional acquisition pathways to bridge the “Valley of Death” and bring innovative technologies to...more
A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more
On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more