Insights

On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization.

On May 1, the NIH issued an update on its grants policy, establishing a “new award structure” that would prohibit foreign subawards from being nested under the parent grant, replacing them with direct awards linked to a prime award. Effective immediately, NIH will no longer issue awards that include a subaward to a foreign entity until the new structure is implemented. The notice did not limit this new structure for foreign recipients to any particular jurisdiction, potentially impacting a wide range of grants and limiting international collaboration with U.S. researchers through the subaward model.

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.

Despite other sweeping changes to the federal government under the Trump administration, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed under former President Biden, remains good law. Below, we report on recent trends in FDA’s implementation and enforcement of MoCRA in the early months of Trump’s presidency.

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.”

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.

On January 6, with increased attention and scrutiny from patients, providers, developers, and payors on the accelerated approval pathway for drugs, the Food and Drug Administration (FDA) released new draft guidance for industry on what it means for a drug’s confirmatory trial to be “underway” under section 506(c) of the Federal Food, Drug, and Cosmetic Act.

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.

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.

On September 12, 2024, the Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”) released a final rule updating 42 CFR Section 93, Public Health Service Policies (“PHS”) on Research Misconduct (“Final Rule”). The research misconduct rule was promulgated almost 20 years ago without subsequent revision, until now. It affects all recipients of Public Health Service funding for biomedical or behavioral research, requiring them to update their policies and procedures governing research misconduct to remain in compliance with the regulation.

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. 

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.