On Monday, October 19, President Trump signed an Executive Order (EO), “Advancing Women’s Health to Improve Outcomes in All Phases of Life,” which directs the US Department of Health and Human Services (HHS) to establish a new Women’s Health Division within the National Institutes of Health (NIH), as well as the creation of the White House Women’s Health Task Force.

The EO directs NIH to establish the Women’s Health Division “within an appropriate institute or center,” within 90 days, to work in coordination with the existing NIH Office of Research on Women’s Health. Per the EO, the goals of the division are to “increase scientific review of understudied women’s health conditions; promote advanced research technologies and personalized medicine; strengthen interdisciplinary research; improve understanding of sex-specific health outcomes; increase inclusion of women and girls in clinical trials; reinforce NIH requirements to account for sex as a biological variable; and translate scientific discoveries into clinical practice.”

Additionally, the EO establishes the White House Women’s Health Task Force, to be co-chaired by Secretary Kennedy and White House Chief of Staff Susie Wiles, who was recently treated for early-stage breast cancer, and will also include the CDC Director, FDA Commissioner, NIH Director, ARPA-H Director, and the CMS Administrator. The Task Force will seek to strengthen federal research, support the translation of this research into “policies, evidence-based medicine, and best clinical practices,” including through grantmaking, advance patient-centered care focused on women’s health, including through pilot programs, and to consult with “ States, tribal nations, local jurisdictions, community-based organizations, faith-based organizations, the private sector, philanthropic entities, and other relevant stakeholders,” to translate research findings into clinical practice.

According to the White House press release, First Lady Melania Trump was directly involved in the drafting of the EO. During the signing of the EO, the First Lady articulated the “First Lady’s Five Pillars of Women’s Health Innovation,” which are: 

1. “Direct research funding towards finding cures that affect women in a unique way.”   
2. “Use super intelligence to enhance our insight of female biology and speed up medical discoveries.” 
3. “Accelerate the process of getting promising therapeutics from laboratories to female patients, while maintaining strict safety standards.”   
4. “Ensure that medical breakthroughs are accessible and affordable to women, regardless of their financial circumstances.”   
5. “Replace generations of silence with open conversation, education, and compassion.” 

The announcement specifically mentions the need for research on “cardiovascular and heart disease, cancer, stroke, Alzheimer’s Disease, autoimmune and inflammatory conditions, osteoporosis, mental health, chronic pain, endometriosis, fibroids, polyendocrine metabolic ovary syndrome (PMOS), infertility, maternal health, menopause, neurological disorders, [and] aging.”   

On October 16, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement new requirements for Medicare Advantage and Part D that were advanced in Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026. In the appropriations package, which was signed into law on February 3, Congress enacted several significant policy changes, including those which the proposed rule will make conforming changes to implement:  

• The Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals Act (Section 6219), which eliminates cost-sharing for generic drugs for Part D beneficiaries that are also full-benefit dual eligible individuals at or below 100 percent of the Federal Poverty Level, beginning with plan year 2028. 
• The Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act (Section 6220), which requires Medicare Advantage Organizations (MAOs) to maintain an accurate provider directory on a public website. Per the statute, MAOs will be required to remove a provider from the directory within five business days if the organization determines that the provider is no longer in network, beginning with plan year 2028. The proposed rule also implements provisions related to directory accuracy analysis, scoring, and disclosures, as well as cost-sharing protections for beneficiaries relying on inaccurate directory entries in certain circumstances. 
• The Modernizing and Ensuring Pharmacy Benefit Manager Accountability Act (Section 6224), which delinks compensation for PBMs and their affiliates, under Part D, from drug prices and other related benchmarks, in addition to establishing new reporting requirements for these entities. The rule proposes and solicits feedback on various definitions, standards, and parameters related to implementing the new policies, which will enter into effect in 2028. 

In the press release, CMS notes that it will release a separate annual proposed rule consisting of policy and technical changes for Parts C and D “later this fall.” The proposed rule is open for public comment until December 15.

On October 14, HHS issued a Statement of Delegation of Authority in the Federal Register, formally delegating “permissive exclusion authority” to the CMS Administrator, which will allow the agency to make decisions to exclude certain individuals and entities from federal healthcare programs. Permissive exclusion authority is traditionally held by the HHS OIG and allows the office discretion to exclude individuals on several grounds, including “provision of unnecessary or substandard services” and “submission of false or fraudulent claims to a Federal healthcare program.” Permissive exclusions are distinct from mandatory exclusions, for which OIG is required to exclude from participation in federal health programs any individual or entity that has been convicted of criminal offenses such as Medicare or Medicaid fraud, patient abuse and neglect, and certain felony convictions. Per the notice, the delegation of permissive exclusion authority to CMS will not impact the delegation of HHS OIG’s existing permissive or mandatory exclusion authority. In the notice, HHS states that CMS is “uniquely positioned to investigate, identify, and develop the evidentiary basis underpinning permissive exclusion determinations,” and that formalizing the delegation “aligns investigative and enforcement responsibilities within a single operating division, reducing redundancy and improving program integrity outcomes.” In a July 21 press conference, HHS Inspector General Thomas March Bell first indicated that HHS was pursuing this change and stated that it would be a “force multiplier,” for the department’s waste, fraud, and abuse efforts.

On October 14, US Food and Drug Administration (FDA) announced the launch of the Rare Disease Framework Initiative, a significant effort to develop a holistic, fit-for-purpose framework for rare disease drug development and review. As described in FDA’s accompanying white paper, the framework is intended to reflect the realities of individual rare diseases, including disease characteristics, patient needs, population size, product type, and the evidence that can realistically be generated in small populations. FDA has emphasized that evidentiary expectations should be tailored to each disease and development program while continuing to meet the statutory standards for safety and effectiveness. The Initiative will be led by FDA’s Rare Disease Innovation Hub in partnership with the Office of the Commissioner, the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER). FDA, in partnership with the Reagan-Udall Foundation for the FDA, will host a hybrid public meeting on October 28 focused on the framework. The meeting will seek input from patients, caregivers, disease advocates, sponsors, researchers, clinicians, and other stakeholders. FDA also has issued a Federal Register Request for Information and Comments to collect written feedback on the initiative, which closes on December 11. In developing the framework, FDA notes that it is particularly interested in feedback on the following areas: 

1. “Fit-for-purpose review of rare disease therapies based on attainable evidence, particular disease state, and population.” 
2. “Consistency and predictability of FDA’s rare disease drug development and review regulatory requirements.” 
3. “FDA engagements with external parties—including patients, disease experts, and researchers—to inform review decision-making for rare disease therapies.” 
4. “Considerations for chemistry, manufacturing, and controls (CMC) specific to rare disease therapies.” 

In addition to the October 28 public meeting and the Request for Comments and Information, FDA plans to convene sector-specific roundtables noting “drug developers, patient and disease advocacy organizations, academic researchers, and practicing clinicians,” as target sectors, as well as internal feedback sessions with CDER and CBER review teams and “other relevant FDA staff.” Together, these forums will provide multiple opportunities for patients and caregivers, developers, researchers, clinicians, and advocacy organizations to help shape the framework. Potential outcomes for the Rare Disease Framework could include new or revised guidance, regulatory changes, improvements to internal processes, enhanced reviewer training, and organizational changes.