Section 1 Short title
This Act may be cited as the “Gwenn’s Law”.
Gwenn’s Law
A BILL
To direct the Secretary of Health and Human Services to carry out a public awareness campaign to increase participation by women in clinical trials that are conducted or supported by the National Institutes of Health, and for other purposes.
Sec. 2 Public awareness campaign to increase participation of women in NIH clinical trials
In general— The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (in this section referred to as the “Secretary”) shall carry out a public awareness campaign to increase the participation of women in clinical trials conducted or supported by the National Institutes of Health.
Targeted outreach— In carrying out the campaign under subsection (a), the Secretary shall increase outreach at hospitals, physicians’ offices, health centers, health care clinics, and other locations that the Secretary determines appropriate.
Priority— In carrying out the campaign under subsection (a), the Secretary shall prioritize increasing the participation of women in clinical trials involving research on, and development of, products to prevent, diagnose, or treat rare diseases and conditions.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2027 through 2031.
Sec. 3 Public awareness campaign to increase awareness of bleeding and clotting disorders in women
In general— The Secretary of Health and Human Services shall carry out a public awareness campaign to increase the number of women participating in programs of the Department of Health and Human Services for research, surveillance, and prevention with respect to bleeding and clotting disorders, including hemophilia.
Authorization of appropriations— To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2027 through 2031.
Sec. 4 Interagency Task Force on Advancing Treatments for Rare Diseases
Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:
“310C. Interagency Task Force on Advancing Treatments for Rare Diseases
“(a) In general—The Secretary shall maintain a permanent task force, to be known as the Interagency Task Force on Advancing Treatments for Rare Diseases (in this section referred to as the “Task Force”). The Secretary shall establish the Task Force not later than 90 days after the date of enactment of the legislation.
“(b) Composition—The Task Force shall be composed of the following members:
“(1) The Secretary.
“(2) The Administrator of the Centers for Medicare & Medicaid Services.
“(3) The Commissioner of Food and Drugs.
“(4) The Director of the National Institutes of Health.
“(5) The Director of the Centers for Disease Control and Prevention.
“(6) Four individuals, to be appointed by the Secretary, who are—
“(A) biopharmaceutical innovators with respect to rare diseases and conditions;
“(B) private health plan administrators; or
“(C) representatives of institutions or organizations conducting federally funded research with respect to rare diseases and conditions.
“(7) Four individuals, to be appointed by the Secretary, who are representatives of rare disease advocacy groups.
“(c) Duties—The Task Force shall—
“(1) assess—
“(A) Federal agency activities concerning rare diseases, including projects involving two or more agencies;
“(B) overall programmatic funding; and
“(C) potential measurable outcomes to include in future reports; and
“(2) coordinate the efforts of the Department of Health and Human Services to incentivize research on, and development of, products for prevention, diagnosis, and treatment with respect to rare diseases and conditions, particularly rare diseases and conditions that disproportionately impact women.”
Sec. 5 Action plan for coordinating HHS efforts with respect to certain rare diseases and conditions
In general— The Secretary of Health and Human Services shall prepare an action plan for coordinating efforts of the Department of Health and Human Services to incentivize research on, and development of, products for prevention, diagnosis, and treatment with respect to rare diseases and conditions that disproportionately impact women.
Submission and public availability— Not later than 180 days after the date of enactment of this Act, the Secretary shall—
complete the action plan required by subsection (a);
submit such action plan to the Congress; and
make such plan publicly available, including by posting on the websites of the Department of Health and Human Services and the National Institutes of Health.