Insights

On March 27, 2025, HHS announced a “dramatic restructuring” of its various agencies and offices in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” HHS also published a Fact Sheet.

In a business environment characterised by tremendous change and impact as a result of the new Trump Administration and the 119th Congress, it is crucial for U.K. businesses to stay informed about developments in the U.S. Crowell is focused on providing clients with timely and actionable insights that can help to inform forward-looking business priorities and strategies.

On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.

On Friday, February 21, Rep. Brett Guthrie (R-KY) and Rep. John Joyce (R-PA), the Chairman and Vice Chairman of the U.S. House Committee on Energy and Commerce, issued a Request for Information (RFI) inviting stakeholders to provide comment as the Committee explores the development of a federal data privacy and security framework. After efforts to consider a bipartisan and bicameral bill failed last year under former Chair Cathy McMorris Rodgers (R-WA), Chairman Guthrie is starting the effort anew, forming a working group with the goal of developing comprehensive legislation “that can get across the finish line.”

On February 18, President Trump issued an Executive Order titled “Ensuring Accountability for All Agencies” that directs independent agencies (as well as Cabinet Departments and their sub-agencies) to route all “proposed and final significant regulatory” and budgetary actions through the White House and the Office of Management and Budget. If implemented to its full extent, this action will significantly strengthen the authority of the White House by weakening the political autonomy of these independent agencies. As an assertion of the President’s inherent powers under Article II of the U.S. Constitution, it also stands to weaken congressional influence over these independent agencies, both through the appropriations and confirmation processes.

Days after President Trump issued an executive order (EO) taking aim at diversity, equity, and inclusion (DEI) programs and prohibiting federal recognition of gender identity apart from biological sex, previously issued draft guidance on diversity in clinical trials was removed from the website of the U.S. Food and Drug Administration (FDA). While the removed guidance was in draft form, it is highly unusual for FDA to revoke or alter draft guidance without issuing a statement or further guidance. This move raises questions about the applicability of statutory obligations to submit clinical trial Diversity Action Plans and the agency’s current thinking on best practices for clinical development.

Senator Joni Ernst (R-IA) has issued a mandate to the Biden Administration: stop the spending spree with the remaining dollars in the CHIPs for America Program.  Senator Ernst’s missive is a direct response to Commerce Secretary Gina Raimondo’s push to have every employee in the Department of Commerce work overtime to spend billions of dollars in CHIPs funding before President Biden leaves office—a push that has already resulted in almost as much spending since the November 5thelection as was spent in the preceding two years since the CHIPs Act was passed.  Senator Ernst warned, the success of the CHIPs initiative “requires thoughtful planning and strategic spending, not binge buying shopping sprees by bureaucrats shoveling billions out the door before” Biden’s term expires. 

Ten states held elections for state attorney general last month. Those states include: Indiana, Missouri, Montana, North Carolina, Oregon, Pennsylvania, Utah, Vermont, Washington and West Virginia. Of the ten elections, there was only one change in political party—Pennsylvania, from Democrat to Republican. Additionally, six states elected new attorneys general—North Carolina, Oregon, Pennsylvania, Utah, Washington and West Virginia. Notably, three attorneys general were elected governor of their respective states. Those incoming governors include Josh Stein of North Carolina, Bob Ferguson of Washington, and Patrick Morrisey of West Virginia. A summary of each new attorney general and attorney general turned governor is below, listed alphabetically.

Since its passage in 2022, the Inflation Reduction Act’s renewable energy tax credits have been in the crosshairs of Congressional Republicans. With many of the Tax Cuts and Jobs Act provisions expiring at the end of 2025, and a full plate of Trump and Congressional Republican Campaign promises for tax cuts in play, the Republicans have pointed to repeal of the IRA as a source of funding to pay for other tax breaks.

On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the E.O.).  The E.O. addresses the national security threat posed by the continued effort of certain countries of concern to access and exploit certain kinds of Americans’ sensitive personal data, which includes health data and genetic data. This builds on DOJ’s Advance Notice of Proposed Rulemaking (ANPRM) published on March 5.  Comments are due on November 29, 2024.

Regardless of what happens in the U.S. elections on November 5, one theme is clear – protectionist policies in international trade are here to stay. To some extent, the key difference between the trade policies of a Harris administration and a second Trump Administration may be one of degree. Vice President Harris is expected to continue the more cautious, incremental approach to trade policy favored by the Biden Administration. A second Trump administration, on the other hand, is expected to pick up where it left off and aggressively use the trade tools at its disposal to try to reset and renegotiate trade relationships with many of the U.S.’s trading partners—particularly those countries with whom the U.S. has a trade deficit.

Before leaving for an extended recess period ahead of the November general election, Congress left unfinished several proposals with ramifications for generic and biosimilar drug competition. This client alert summarizes some of that legislation and possible next steps in the “lame duck” period before the end of the year.

With a new President entering office in January 2025 and many key Tax Cuts and Jobs Act provisions expiring (TCJA) on December 31, 2025, both sides of the aisle are teeing up a massive effort to renew, extend, roll back, or make permanent various provisions of former President Trump’s signature tax bill and President Biden’s signature climate bill. Just about every business sector will be impacted by how Congress and the new administration approach TCJA and other tax issues. Here is a sneak peek into the top five issues our tax and policy experts expect to come up in that debate based on the campaign positions of Vice President Harris and former President Trump.

The opportunity to create and shape major policies impacting the transportation sector will be teed up in 2025. Some changes will be led or initiated by the change in Administration, some will come from expected retirements or potential changes in majorities, and other changes will be put in the forefront of congressional leaders because of expiring laws. In this client alert, part of our Election 2024 series, we identify some of the expected changes, opportunities, and challenges ahead for transportation policy.

Health care issues remain among American voters’ top concerns heading into the 2024 general election, and former President Trump and Vice President Harris have starkly different approaches and records on the issue. In this client alert, part of our Election 2024 series, we analyze the candidates’ priorities in health care, or at least what we know of them. For all of the concern about health care in the electorate, both candidates have been criticized for not revealing enough detail about their respective plans.

To keep our clients informed about the proposed policies and announced platforms of the presidential candidates and the potential composition of the new Congress, Crowell is launching its Election 2024 series. The series will provide insight and analysis on what the election of Vice President Harris or former President Trump could mean for business, as well as explore what’s at stake in key state and congressional races. 

Congress enacted the UFLPA on December 23, 2021 in response to alleged forced labor violations occurring in the People’s Republic of China. The UFLPA supports U.S. Customs and Border Protection’s (CBP) enforcement of Section 307 of the Tariff Act of 1930. The act aims to prevent the importation of goods sourced and/or made in whole or in part with forced labor from China into the US by imposing a rebuttable presumption that holds that any goods “mined, produced, or manufactured wholly or in part” in the XUAR or “produced by an entity on the UFLPA Entity List” are prohibited from import into the US. The UFLPA’ s rebuttable presumption went into effect on June 21, 2022.  

On Wednesday, May 22, the House Energy and Commerce Health Subcommittee held a hearing that included a rare appearance from all three directors of the Food and Drug Administration’s (FDA) human medical product centers: Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, Center for Biologics Evaluation and Research (CBER) Director Peter Marks, and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren. The three center directors provided updates on the implementation of new programs and authorities included in the Food and Drug Omnibus Reform Act (FDORA) and the latest prescription drug and medical device user fee reauthorizations while also fielding questions on a range of topics from members. Topics discussed included:

Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation.

The Treasury and IRS published their final rules on transferability for clean energy tax credits on April 30, 2024. The final rules include very few changes from the proposed regulations and rejected many of the suggestions offered by commenters during the public hearing.