Puspan. L. 111–148, title III, § 3509(j), Mar. 23, 2010, 124 Stat. 537, provided that: “Nothing in this section [enacting this section, sections 242s, 299span–24a, and 914 of this title and section 399span of Title 21, Food and Drugs, amending sections 287d, 290aa, 299span–25, and 299span–26 of this title, and enacting provisions set out as notes under this section] (or the amendments made by this section) shall be construed to limit the authority of the Secretary of Health and Human Services with respect to women’s health, or with respect to activities carried out through the Department of Health and Human Services on the date of enactment of this section [Mar. 23, 2010].”

Puspan. L. 111–148, title III, § 3509(a)(2), Mar. 23, 2010, 124 Stat. 533, provided that:

Puspan. L. 114–255, div. B, title XIII, § 13005, Dec. 13, 2016, 130 Stat. 1286, provided that:

Puspan. L. 111–148, title III, § 3509(h), Mar. 23, 2010, 124 Stat. 537, provided that: “Nothing in this section [enacting this section, sections 242s, 299span–24a, and 914 of this title and section 399span of Title 21, Food and Drugs, amending sections 287d, 290aa, 299span–25, and 299span–26 of this title, and enacting provisions set out as notes under this section] and the amendments made by this section may be construed as establishing regulatory authority or modifying any existing regulatory authority.”

Puspan. L. 111–148, title III, § 3509(i), Mar. 23, 2010, 124 Stat. 537, provided that: “Notwithstanding any other provision of law, a Federal office of women’s health (including the Office of Research on Women’s Health of the National Institutes of Health) or Federal appointive position with primary responsibility over women’s health issues (including the Associate Administrator for Women’s Services under the Substance Abuse and Mental Health Services Administration) that is in existence on the date of enactment of this section [Mar. 23, 2010] shall not be terminated, reorganized, or have any of it’s [sic] powers or duties transferred unless such termination, reorganization, or transfer is approved by Congress through the adoption of a concurrent resolution of approval.”

Ex. Ord. No. 14120, Mar. 18, 2024, 89 F.R. 20095, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. My Administration is committed to getting women the answers they need about their health. For far too long, scientific and biomedical research excluded women and undervalued the study of women’s health. The resulting research gaps mean that we know far too little about women’s health across women’s lifespans, and those gaps are even more prominent for women of color, older women, and women with disabilities.

The notion of including women in clinical trials used to be revolutionary—which means many diagnostics and treatments were developed without women in mind and thus failed to account for women’s health. Over 30 years ago, the Congress passed the landmark National Institutes of Health Revitalization Act of 1993 (Public Law 103–43) [see Tables for classification] to direct the National Institutes of Health (NIH), the largest public funder of biomedical research in the world, to include women and people of color in NIH-funded clinical research. In 2016, the Congress built on these requirements in the 21st Century Cures Act (Public Law 114–255) [see Tables for classification], which directed the NIH to further its pursuit of women’s health research, including by strengthening clinical trial inclusion and data analysis, developing research and data standards to advance the study of women’s health, and improving NIH-wide coordination on women’s health research.

These policies led to significant increases in women’s participation in clinical trials, and ongoing investments in biomedical research have supported breakthroughs in women’s health. Through the discovery of genetic factors that increase the risk of breast cancer and innovations in mammography, we have transformed our approach to prevention, early detection, and treatment, and have improved outcomes for women facing a breast cancer diagnosis. We have improved access to life-saving treatments for women with severe heart failure by ensuring that the devices they need are the right size for a woman’s body. We have also identified some of the most characteristic symptoms of heart attack in women, which are different from those in men—discoveries that have helped deliver faster treatment to women when every second counts. This is what we can achieve when we invest in women’s health research.

It is time, once again, to pioneer the next generation of discoveries in women’s health. My Administration seeks to fundamentally change how we approach and fund women’s health research in the United States. That is why I established the first-ever White House Initiative on Women’s Health Research (Initiative)—which is within the Office of the First Lady and includes a wide array of executive departments and agencies (agencies) and White House offices—to accelerate research that will provide the tools we need to prevent, diagnose, and treat conditions that affect women uniquely, disproportionately, or differently.

Together with the First Lady’s tireless efforts, the Initiative is already galvanizing the Federal Government to advance women’s health, including through investments in innovation and improved coordination within and across agencies. We are also mobilizing leaders across a wide range of sectors, including industry, philanthropy, and the medical and research communities, to improve women’s health.

It is the policy of my Administration to advance women’s health research, close health disparities, and ensure that the gains we make in research laboratories are translated into real-world clinical benefits for women. It is also the policy of my Administration to ensure that women have access to high-quality, evidence-based health care and to improve health outcomes for women across their lifespans and throughout the country.

I will continue to call on the Congress to provide the transformative investments necessary to help our researchers and scientists answer today’s most pressing questions related to women’s health. Investing in innovation in women’s health is an investment in the future of American families and the economy. At the same time, agencies must use their existing authorities to advance and integrate women’s health across the Federal research portfolio, close research gaps, and make investments that maximize our ability to prevent, diagnose, and treat health conditions in women.

Sec. 2. Definitions. For purposes of this order:

(a) The term “women’s health research” means research aimed at expanding knowledge of women’s health across their lifespans, which includes the study and analysis of conditions specific to women, conditions that disproportionately impact women, and conditions that affect women differently.

(span) The term “White House Initiative on Women’s Health Research” means the interagency, advisory body established by the Presidential Memorandum of November 13, 2023 (White House Initiative on Women’s Health Research) [set out below], to advance women’s health research.

(c) The term “agency Members of the Initiative” refers to the Secretary of Defense, the Secretary of Agriculture, the Secretary of Health and Human Services, the Secretary of Veterans Affairs, the Administrator of the Environmental Protection Agency, and the Director of the National Science Foundation.

Sec. 3. Further Integrating Women’s Health Research in Federal Research Programs. (a) Building on research and data standards issued by the NIH in 2016, agency Members of the Initiative shall consider actions to develop or strengthen research and data standards that enhance the study of women’s health across all relevant, federally funded research and other Federal funding opportunities. Agency Members of the Initiative shall consider issuing new guidance, application materials, reporting requirements, and research dissemination strategies to advance the study of women’s health, including to:

(i) require applicants for Federal research funding, as appropriate, to explain how their proposed study designs will consider and advance our knowledge of women’s health, including through the adoption of standard application language;

(ii) consider women’s health, as appropriate, during the evaluation of research proposals that address medical conditions that may affect women differently or disproportionately;

(iii) improve accountability for grant recipients, including, as appropriate, by requiring regular reporting on their implementation of, and compliance with, research and data standards related to women’s health, including compliance with recruitment milestones; and

(iv) improve the recruitment, enrollment, and retention of women in clinical trials, including, as appropriate, by reducing barriers through technological and data sciences advances.

(span) Within 30 days of the date of this order [Mar. 18, 2024], the Chair of the Initiative and the Director of the NIH Office of Research on Women’s Health, in consultation with the Director of the Office of Management and Budget (OMB), shall establish and co-chair a subgroup of the Initiative to promote interagency alignment and consistency in the development of agency research and data standards to enhance the study of women’s health.

(c) Within 90 days of the date of this order, agency Members of the Initiative shall report to the Chair of the Initiative on actions taken to strengthen research and data standards to enhance the study and analysis of women’s health and related conditions.

(d) Within 180 days of the date of this order and on an annual basis thereafter, agency Members of the Initiative shall report to the President on the status of implementation of research and data standards.

Sec. 4. Prioritizing Federal Investments in Women’s Health Research. (a) Agency Members of the Initiative shall identify and, as appropriate and consistent with applicable law, prioritize grantmaking and other awards to advance women’s health research, with an emphasis on:

(i) promoting collaborative, interdisciplinary research across fields and areas of expertise;

(ii) addressing health disparities and inequities affecting women, including those related to race, ethnicity, age, socioeconomic status, disability, and exposure to environmental factors and contaminants that can directly affect health; and

(iii) supporting the translation of research advancements into improved health outcomes.

(span) Agency Members of the Initiative shall take steps to promote the availability of federally funded research and other Federal funding opportunities to advance women’s health, including through the development and inclusion of standard language related to women’s health, as appropriate, in all relevant notices of funding opportunity and through better facilitating potential grant applicants’ access to information about funding opportunities related to women’s health research.

(c) To advance innovation, commercialization, and risk mitigation, agency Members of the Initiative shall:

(i) identify and, as appropriate and consistent with applicable law, seek ways to use innovation funds, challenges, prizes, and other mechanisms to spur innovation in women’s health;

(ii) invest in innovation to accelerate women’s health research, including through or in collaboration with the Advanced Research Projects Agency for Health and the Congressionally Directed Medical Research Programs;

(iii) support the role of small businesses and entrepreneurs in advancing innovation in women’s health research, including through Small Business Innovation Research Programs and Small Business Technology Transfer Programs; and

(iv) invest in translational science to convert research findings and discoveries into treatments and interventions that improve women’s health outcomes and reduce health disparities, including through the Department of Agriculture National Institute of Food and Agriculture research programs.

(d) In implementing section 8(span) of Executive Order 14110 of October 30, 2023 (Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence) [15 U.S.C. 9401 note], the Secretary of Health and Human Services, in consultation with the Director of the National Science Foundation, shall consider the opportunities for and challenges that affect women’s health research in the responsible deployment and use of artificial intelligence (AI) and AI-enabled technologies in the health and human services sector.

Sec. 5. Galvanizing Research on Women’s Midlife Health. (a) Within 90 days of the date of this order, to address research gaps in understanding women’s health and diseases and conditions associated with women’s midlife and later years, the Secretary of Health and Human Services shall:

(i) launch a comprehensive assessment of the current state of the science on menopause to develop an evidence-based research agenda that will guide Federal and private sector investments in menopause-related research;

(ii) evaluate evidence-based interventions and strategies to improve women’s experiences in the menopausal and perimenopausal periods, including the delivery of treatments for women experiencing menopause in clinical care settings;

(iii) consider developing new common data elements and survey tools to expand the ethical and equitable collection of data on issues related to women’s midlife health; and

(iv) develop new comprehensive resources to help ensure that the public has evidence-based information about menopause, including menopause-related research initiatives, findings, and symptom-prevention and treatment options.

(span) The Secretary of Defense and the Secretary of Veterans Affairs shall evaluate the needs of women service members and veterans related to midlife health and shall develop recommendations to support improved treatment and targeted research of midlife health issues, including menopausal symptoms.

Sec. 6. Assessing Unmet Needs to Support Women’s Health Research. The Director of OMB and the Assistant to the President and Director of the Gender Policy Council (Directors) shall lead an effort, in collaboration with the Initiative, to identify current gaps in Federal funding for women’s health research and shall submit recommendations to the President describing the additional funding and programming necessary to catalyze research on women’s health, including in priority areas within women’s health as identified by the Initiative, as follows:

(a) Within 90 days of the date of this order, the Directors shall, in consultation with the Initiative, develop guidance for assessing additional funding that agencies need to close research gaps in women’s health.

(span) Within 180 days of the date of this order, Members of the Initiative shall consult the guidance described in subsection (a) of this section and shall each submit a report to the Directors that identifies the funding needed to catalyze research on women’s health.

(c) Based on the reports described in subsection (span) of this section, the Directors shall develop and submit recommendations to the President on steps the Federal Government should take to catalyze research on women’s health. These recommendations shall identify any statutory, regulatory, budgetary, or other changes that may be necessary to ensure that Federal laws, policies, practices, and programs support women’s health research more effectively.

(d) Following the submission of the recommendations described in subsection (c) of this section, each Member of the Initiative shall report annually to the Directors on progress made in response to those recommendations and to improve the study of women’s health. The Director of OMB shall provide a summary of Members’ progress and any new recommendations to the President on an annual basis, consult with each Member on their women’s health research funding needs during the annual budget process, and calculate Federal funding for women’s health research on an annual basis.

Sec. 7. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(span) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Memorandum of President of the United States, Nov. 13, 2023, 88 F.R. 80085, provided:

Memorandum for the Heads of Executive Departments and Agencies

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. Women make up half of the United States population, but for too long, a lack of timely research and data on women’s health has left health care providers without important tools to diagnose and treat millions of women with debilitating conditions, including cardiovascular disease, Alzheimer’s disease, autoimmune disorders, mental health conditions, and conditions specific to women such as endometriosis and fibroids.

Beyond the immediate health consequences, underinvesting in women’s health research can decrease women’s well-being and quality of life, hold women back in the workplace, and affect their families’ economic security. By contrast, increasing investments in women’s health research can yield broad societal gains, including lower health care costs and a more productive and inclusive workforce.

To address pervasive gaps in our knowledge of women’s health, we must accelerate research on the unique health needs of women across their lifespans. Research gaps are especially acute for diseases and conditions that are more prevalent among women and for health conditions associated with women’s midlife and later years, including perimenopause and menopause. Gaps are often even more significant for those who have been historically underrepresented in, or excluded from, research.

We can—and must—increase our efforts to invest in research that maximizes our ability to prevent, diagnose, and treat health conditions in women across the United States. Meaningful progress requires robust, dedicated research infrastructure—including a strong, diverse research workforce—and investment within and beyond the Federal Government. We all have a part to play in galvanizing women’s health research, developing innovative and cutting-edge interventions that promote women’s health, and ensuring that women across the United States have access to high-quality health care.

Accordingly, I hereby direct the following actions:

Sec. 2. Establishment. There is established, within the Office of the First Lady, a White House Initiative on Women’s Health Research (Initiative).

Sec. 3. Membership. (a) The Initiative shall be led by a Chair designated by the President who shall hold a dual role in the Office of the First Lady and on the staff of the White House Gender Policy Council.

(span) In addition to the Chair, the members of the Initiative shall consist of the heads of the following executive departments and agencies (agencies) and offices, or their designees:

(i) the Office of the Vice President;

(ii) the Department of Defense;

(iii) the Department of Agriculture;

(iv) the Department of Health and Human Services;

(v) the Department of Veterans Affairs;

(vi) the Environmental Protection Agency;

(vii) the Office of Management and Budget;

(viii) the Domestic Policy Council;

(ix) the Office of Science and Technology Policy;

(x) the National Science Foundation;

(xi) the National Institutes of Health;

(xii) the Food and Drug Administration;

(xiii) the Centers for Disease Control and Prevention;

(xiv) the Indian Health Service;

(xv) the Centers for Medicare and Medicaid Services;

(xvi) the Health Resources and Services Administration;

(xvii) the Substance Abuse and Mental Health Services Administration;

(xviii) the Agency for Healthcare Research and Quality;

(xix) the Advanced Research Projects Agency for Health;

(xx) the National Institutes of Health Office of Research on Women’s Health; and

(xxi) the heads of such other agencies and offices as the Chair may, from time to time, designate.

(c) The Department of Health and Human Services shall provide funding and administrative support as may be necessary for the performance and functions of the Initiative, to the extent permitted by law and within existing appropriations.

(d) At the direction of the Chair, the Initiative may establish subgroups consisting exclusively of Initiative members or their designees, as appropriate, including to coordinate across agency offices dedicated to women’s health.

Sec. 4. Mission and Functions. (a) The mission of the Initiative is to advance women’s health research in the United States. The functions of the Initiative are advisory only and shall include, consistent with applicable law, the following actions with the goal of advancing women’s health research:

(i) assessing the Federal research landscape to identify opportunities for additional investments that could catalyze significant progress in addressing women’s health needs;

(ii) setting Initiative-wide priorities to help guide strategic Federal research investments;

(iii) improving coordination among agencies and offices pursuing women’s health research, including by better integrating research efforts and facilitating interdisciplinary research;

(iv) developing policy recommendations to better ensure that the health needs of women are considered, assessed, and reported for Federal research and data collection efforts, where feasible and in accordance with current research and data collection and analysis guidelines;

(v) forming targeted recommendations to address health disparities and inequities affecting women, including those related to race, ethnicity, age, socioeconomic status, disability, and exposure to environmental factors and contaminants that can directly affect health;

(vi) developing recommendations to support the translation of research advancements into practical benefits for patients and providers;

(vii) identifying opportunities to develop public-private partnerships and to increase coordination of Federal efforts with the private and philanthropic sectors in order to drive innovation;

(viii) engaging the scientific and research communities, including by helping promote the publication and dissemination of actionable research and data on women’s health and by making Federal datasets available to support research;

(ix) assessing opportunities to recruit, train, and support women pursuing health and biomedical research careers to help strengthen and diversify the research workforce; and

(x) identifying ways to increase public awareness of the need for greater investment in and attention to women’s health research, as well as women’s health outcomes.

(span) Consistent with the objectives of this memorandum and applicable law, the Initiative may gather relevant information from external stakeholders, including Federal, State, local, Tribal, and territorial government officials; researchers and academics; women’s health organizations; philanthropic leaders; industry stakeholders; and other entities and persons that may assist the Initiative in accomplishing the objectives of this memorandum.

Sec. 5. Recommendations to the President. (a) Within 45 days of the date of this memorandum [Nov. 13, 2023], the members of the Initiative or their designees shall provide recommendations to the President, through the Chair, on concrete actions that agencies and offices can take to advance women’s health research.

(span) The heads of agencies and offices participating in the Initiative shall assist and provide information to the Chair, consistent with applicable law, as may be necessary to carry out the functions of the Initiative. Each participating agency and office shall bear its own expense for participating in the Initiative.

(c) The heads of agencies and offices participating in the Initiative, or their designees, shall inform the President, through the Chair, on progress implementing this memorandum at least twice each year.

Sec. 6. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(span) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.