Looking Ahead
This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead several federal agencies. Nominations that are expected to be considered on the Senate floor as soon as this week include the nomination of Dr. Susan Monarez to be director of the Centers for Disease Control and Prevention (CDC). Dr Brian Christine, who has been nominated to be assistant secretary of the U.S. Department of Health and Human Services (HHS), received a favorable vote from the Senate Committee on Health, Education, Labor and Pensions (HELP) and may have his nomination considered by the Senate in short order. Conversations are picking up about reviving portions of the health package that was ultimately pulled from the December 2024 continuing resolutions. Members seek to find a way to advance bipartisan provisions as part of an agreement to fund the government beyond Sept. 30, 2025, and the end of the year.
Hearings This Week
There are no hearings in the House this week, as the chamber is out of session.
The Senate Committee on HELP will hold a legislative hearing on July 30, 2025 to consider the following:
- S. 2292, Over-the-Counter Monograph Drug User Fee Amendments
- S. 1440, Uniformed Services Leave Parity Act
- S. ___, Kay Hagan Tick Reauthorization Act
- S. 2301, Improving Care in Rural America Reauthorization Act of 2025
- S. 1727, Employee Ownership Fairness Act of 2025
- S. 1728, Employee Ownership Representation Act of 2025
- S. ___, Retire Through Ownership Act
The Senate HELP Committee will also hold a hearing on July 31, 2025, titled "Making Health Care Affordable: Solutions to Lower Costs and Empower Patients."
The Senate Committee on Appropriations will hold a full committee markup on July 31, 2025, on the Defense Appropriations Act, as well as the U.S. Departments of Labor, Health and Human Services (HHS), and Education Appropriations Act.
Week in Review
The House Committee on Ways and Means held a joint hearing on July 22, 2025, of the Health and Oversight Subcommittees. The hearing focused on Medicare Advantage (MA), exploring its historical lessons, current insights and future opportunities. On July 23, 2025, the House Committee on Energy and Commerce conducted a markup of the Over-the-Counter Monograph User Fee Act (OMUFA). Also on July 23, 2025, the Senate HELP Committee was scheduled to hold a hearing on OMUFA, but it was postponed. However, the HELP Committee did proceed with the nomination hearing for Dr. Brian Christine to serve as an assistant secretary of the HHS.
Administrative Updates
Executive Order Updates
The Trump Administration has continued to release wide-ranging Executive Orders (EOs). For the most recent updates, see our "Trump's 2025 Executive Orders: Updates and Summaries" tracking chart.
HHS and CMS To Launch a National Health Data Initiative
This week, HHS and Centers for Medicare & Medicaid Services (CMS) leadership are expected to launch a major federal health tech initiative to modernize data sharing across Medicare, Medicaid and provider networks, with a focus on patient-centered access. The initiative is reported to include a national provider directory, streamlined digital identity verification, expanded Blue Button 2.0 capabilities and a trusted data exchange framework to enable seamless, secure interoperability. In addition, top tech executives are expected in Washington, D.C. on July 30, 2025, for a White House event hosted by HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz to formally unveil the plan.
U.S., European Union Strike Broad Trade Agreement to Include Pharmaceuticals
The U.S. and the European Union (EU) announced on July 27, 2025, that a trade agreement had been reached to impose a 15 percent tariffs on most European goods imported by the U.S. As part of the agreement, a 15 percent tariff on pharmaceutical products will be included, while a separate Section 232 probe into the potential national security threat posed by pharmaceutical products remain ongoing. A 15 percent tariff is half of the previous tariff rate that President Donald Trump had previously stated he would impose. As part of the agreement, the EU agrees to purchase $750 billion worth of energy products and committed to an additional $600 billion of investments into the U.S. Additional details are expected in short order, including on whether any pharmaceutical product or medical device may be exempted from the 15 percent tariff.
Staffing Changes
- The Senate voted to confirm Terry Cole as administrator of the U.S. Drug Enforcement Administration (DEA) in a 50-47 vote on July 22, 2025.
- Sonja Fulmer, acting director of U.S. Food and Drug Administration's (FDA) Digital Health Center of Excellence (DHCoE), will be leaving the agency, following the notable departures of former director Troy Tazbaz, top artificial intelligence (AI) official Tala Fakhouri, and the agency’s acting director, Jacqueline Corrigan-Curay.
Legislative Updates
MA AI Legislation Forthcoming
Rep. Judy Chu (D-Calif.) announced during a House Committee on Ways and Means subcommittee hearing on July 22, 2025, that she plans to introduce legislation requiring transparency in how MA plans use AI. The proposal responds to growing concerns that AI-driven tools are being used to deny medically necessary care, often without accounting for individual patient circumstances. Chu's initiative builds on prior bipartisan calls for increased oversight of algorithmic decision-making in MA coverage determinations.
Health Priorities Bill Potentially In the Works
Sens. Bill Cassidy (R-La.) and Mike Crapo (R-Idaho) signaled that they are working on a bill that will encompass a variety of bipartisan health priorities, which may include provisions that were dropped from the December 2024 funding package, as well as other priorities such as the Treat and Reduce Obesity Act (TROA). The legislation is under consideration for inclusion in a broader package (potentially a continuing resolution to fund the government beyond Sept. 30, 2025, and avoid a government shutdown) or make it as part of a possible year-end funding bill. Democrats will seek to include an extension of the advanced premium tax credits (APTCs), currently set to expire at the end of the year, as part of any package containing healthcare provisions.
Senate HELP Committee Chair Writes to Major Insurers, Children's Hospitals on Compliance with EO 14187
Senate HELP Committee Chair Bill Cassidy (R-La.) announced on July 22, 2025, that he had sent letters to organizations representing major health insurance companies, hospitals, community health centers and an individual health insurance company and hospital, to request additional information on how each entity is complying with President Trump's EO 14187 titled "Protecting Children from Chemical and Surgical Mutilation." Responses are requested by Aug. 7, 2025, and questions ask for information regarding steps taken to comply with the EO, any guidance issued to members, as well as federal funding received.
Federal Court Blocks Implementation of New Provision from OBBB
On July 28, 2025, a federal judge blocked the Trump Administration from enforcing reductions in funding to Medicaid payments for nonprofit organizations that provide reproductive and other healthcare services. A provision from the One Big Beautiful Bill Act (OBBB) sought to prohibit for one year Medicaid funding for "prohibited" entities primarily engaged in providing family planning services, reproductive healthcare services, and "related medical care" that also provide abortion services in certain circumstances. Existing federal laws prevent federal funding from being used to pay for abortion care, except in limited circumstances. The judge found the provision violated the U.S. Constitution, specifically related to prohibitions against a "bill of attainder," which is a concept prohibiting entities from being singled out and punished without a legal trial. The provision specifically identifies entities whose revenues were above $800,000, a nod to specific entities. Also in question is the law's applicability to locations of nonprofit entities that do not perform abortions and whether that prohibition is in conflict with the right of association, as outlined in the First Amendment.
Regulatory Updates
NIH Guidance on AI in research
The National Institutes of Health (NIH) released guidance NOT-OD-25-132: Supporting Fairness and Originality in NIH Research Applications on July 17, 2025. NIH Associate for Data Science, Dr. Susan Gregurick, previously outlined how NIH will leverage Generative AI (GenAI) to advance Common Data Elements (CDEs). The new policy addresses the use of AI in preparing research grant applications and introduces two key measures:
- AI Usage Restrictions. While limited AI assistance is allowed, applications must reflect original thought. Submissions that are substantially AI-generated may be considered plagiarized or in violation of NIH's research integrity standards, potentially leading to enforcement actions such as grant suspension or termination.
- Application Cap. NIH now limits each Principal Investigator (PI) to six new, renewal, resubmission or revision applications per calendar year (excluding T and R13 activity codes). This change responds to a rise in high-volume submissions, some potentially AI-assisted.
HHS, FDA Praise Association's Vow to Remove Artificial Colors from America's Food Supply
The HHS and FDA commended a consumer brand association on July 22, 2025, for its voluntary pledge to eliminate artificial colors from the U.S. food supply. The initiative targets synthetic dyes such as Federal Food, Drug, and Cosmetic Act (FD&C) Blue No. 1 and 2, Green No. 3, Red No. 40, and Yellow Nos. 5 and 6, with a full phase-out deadline of Dec. 31, 2027. Additionally, the Consumer Brands Association (CBA) committed to removing these dyes from foods served in schools by the 2026-2027 school year.
HHS Secretary Kennedy and FDA Commissioner Dr. Marty Makary praised the move as a major step in the Trump Administration's "Make America Healthy Again" (MAHA) initiative. The FDA also approved four new natural color additives to support the transition to cleaner food labeling and nutrition standards.
HHS, USDA Issue RFI to Shape UPF Definition
The HHS and U.S. Department of Agriculture (USDA) announced plans on July 23, 2025, to solicit input to shape a single definition of ultra-processed food. The HHS, FDA and USDA jointly requested public comment by announcing a Request for Information (RFI) regarding a "unified, widely understood" definition, which is likely to prompt significant attention from food industry and public health stakeholders. HHS Secretary Kennedy has long been focused on the connection between processed foods and chronic disease, a focus that has shaped the work of the MAHA Commission throughout this year.
The RFI notes that various states have taken action to a different effect for several years, ranging from a focus on substances that have an effect on food (such as to stabilize, thicken, color or flavor), processing steps associated with a food, ingredient listing and labeling, and more. The RFI requests stakeholders outline the following in their responses:
- whether an existing classification system or policy should be considered, including challenges and advantages to those existing systems or policies, and whether a system (or part of a system) is suitable for the U.S.
- regarding ingredient labeling, what types of ingredients and volume of ingredient should be considered to characterize an Ultra-Processed Food (UPF)
- whether flavors and colors should be considered separately when defining an UPF
- the physical manufacturing, biological and chemical processes that might be used to characterize an UPF
- whether there is a term other than UPF that can be used to describe products
- whether nutrition or other attributes should be considered
More information on the RFI may be found online. The deadline to submit responses is 60 days after being published in the Federal Register.
GAO Finds Administration Breached Impoundment Control Act
The U.S. Government Accountability Office (GAO) issued a new analysis of the HHS' withholding of funds appropriated by Congress for the Head Start program. The GAO report finds that HHS violated the Impoundment Control Act when it held back funding appropriated by Congress for the program. With the Trump Administration considering submitting another recissions package to Congress for consideration to allow the Trump Administration to not spend additional funding appropriated by Congress, it is likely that litigation on this and other issues will continue to move forward.
FDA Opens Applications for CNPV Pilot Program
The FDA is now accepting statements of interests from drug and biologic companies who wish to participate in the Commissioner's National Priority Voucher (CNPV) Pilot Program. The FDA intends to issue five vouchers to companies, which can be used to accelerate FDA review of drug and biologic products from 10-12 months to 1-2 months. A voucher may be redeemed for a product at any point in development and may not be bought and sold, but may be retained through company changes in ownership. Notably, companies are limited to a single submission, therefore any interest in the program must be carefully weighed by companies and statements of interest should be crafted carefully.
It remains to be seen whether companies will be allowed to submit new statements of interest in future years of the pilot program. Submissions will be evaluated by a group of senior FDA staff and will be led by the FDA's Office of the Chief Medical and Scientific Officer. It is also unclear whether companies whose submissions are not selected will have recourse to request feedback on the FDA's decision. There is currently no deadline associated with submitting statements of interest.
Any submission must affirm that the product a voucher is sought for meets one of the following specific priorities:
- Addressing a U.S. Public Health Crisis. An example could include developing a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential.
- Delivering More Innovative Cures for the American People. The focus for this priority is a transformative impact that far outstrips the threshold for breakthrough therapy designation. Examples could include creating a novel immunotherapy that reprograms the body's immune system to fight multiple diseases or transforming mental healthcare through a novel treatment for PTSD.
- Addressing a Large Unmet Medical Need. This includes a condition that available therapies do not adequately diagnose or treat, including drugs to treat or prevent rare diseases or addressing America's chronic disease crisis.
- Onshoring Drug Development and Manufacturing to Advance the Health Interests of Americans and Strengthen U.S. Supply Chain Resiliency. Examples could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the U.S., or a clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care.
- Increasing Affordability. This could include a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs.
HHS Releases The White House Plan for AI, EOs
The White House released "Winning the Race: America's AI Action Plan" on July 23, 2025, outlining more than 90 federal actions to boost U.S. leadership in AI. The plan envisions a new era of innovation and progress, driven by three pillars: accelerating AI innovation, building national AI infrastructure and leading in global AI diplomacy and security. To implement this strategy, President Trump signed three EOs: one to promote the export of American AI technologies, another to fast-track permitting for data centers and a third to prohibit federal use of AI systems that incorporate diversity or climate-related criteria. For a detailed analysis, see Holland & Knight's previous alert, "America's AI Action Plan: What's In, What's Out, What's Next," July 25, 2025.
FTC-DOJ Drug Pricing Panel
At the first Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) Drug Pricing Panel held on July 24, 2025, patent reform was the central focus in efforts to reduce prescription drug costs. Experts urged the FTC and DOJ to address tactics that they argue delay generic and biosimilar competition such as "pay-for-delay" settlements and excessive patent filings that may extend exclusivity without meaningful innovation. The panel included sessions on blocking initial competition through supply agreements and restricted distribution, as well as post-entry strategies like product hopping, rebate manipulation and alleged price-fixing. The next session, titled "Turning Insights into Action to Reduce Drug Prices," will take place on Aug. 4, 2025, at 2 p.m. ET. It will highlight the most impactful discussions from the previous panels and explore additional strategies to reduce drug pricing in the U.S.
Judicial Updates
Coalition of State Attorneys General Challenge CMS Marketplace Integrity Rule
A group of state attorneys general have filed a lawsuit challenging CMS' final marketplace integrity rule, alleging that the rule violates the Administrative Procedures Act (APA) and goals of the Affordable Care Act (ACA). The group has asked for a preliminary injunction to prevent the rule from taking effect. This is the second legal challenge to the final rule, and courts are expected to begin hearing arguments in the cases as soon as Aug. 14, 2025. Attorneys general from the following states have joined the challenge: California, Colorado, Connecticut, Delaware, Illinois, Maine, Michigan, Minnesota, Maryland, Massachusetts, Nevada, New Jersey, New Mexico, New York, Oregon and Pennsylvania.
Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.
