H.R. 9877

Health Equity and Accountability Act of 2026

Sponsor: Raul Ruiz

26 cosponsors
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I Data collection and reporting

Sec. 1008. Safety and effectiveness of drugs with respect to racial and ethnic background

(a) In general. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505G (21 U.S.C. 355h) the following:

Text this section adds to the law

505H. Safety and effectiveness of drugs with respect to racial and ethnic background

(a) Preapproval studies. If there is evidence of a racial or ethnic disparity in safety or effectiveness with respect to a drug or biological product, then—

(1)

(A) in the case of a drug, the investigations required under section 505(b)(1)(A) shall include adequate and well-controlled investigations of the disparity; or

(B) in the case of a biological product, the evidence required under section 351(a) of the Public Health Service Act for approval of a biologics license application for the biological product shall include adequate and well-controlled investigations of the disparity; and

(2) if the investigations described in subparagraph (A) or (B) of paragraph (1) confirm that there is such a disparity, the labeling of the drug or biological product shall include appropriate information about the disparity.

(b) Postmarket studies

(1) In general. If there is evidence of a racial or ethnic disparity in safety or effectiveness with respect to a drug for which there is an approved application under section 505 of this Act or of a biological product for which there is an approved license under section 351 of the Public Health Service Act, the Secretary may by order require the holder of the approved application or license to conduct, by a date specified by the Secretary, postmarket studies to investigate the disparity.

(2) Labeling. If the Secretary determines that the postmarket studies confirm that there is a disparity described in paragraph (1), the labeling of the drug or biological product shall include appropriate information about the disparity.

(3) Study design. The Secretary may, in an order under paragraph (1), specify all aspects of the design of the postmarket studies required under such paragraph for a drug or biological product, including the number of studies and study participants, and the other demographic characteristics of the study participants.

(4) Modifications of study design. The Secretary may, by order and as necessary, modify any aspect of the design of a postmarket study required in an order under paragraph (1) after issuing such order.

(5) Study results. The results from a study required under paragraph (1) shall be submitted to the Secretary as a supplement to the drug application or biologics license application.

(c) Applications under section 505(j)

(1) In general. A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 on the basis that the labeling of the drug omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug, whether derived from investigations or studies required under this section or derived from other sources, when the omitted information is protected by patent or by exclusivity under section 505(j)(5)(F).

(2) Labeling. Notwithstanding paragraph (1), the Secretary may require that the labeling of a drug approved under section 505(j) that omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug include a statement of any appropriate contraindications, warnings, or precautions related to the disparity that the Secretary considers necessary.

(d) Definition. In this section, the term evidence of a racial or ethnic disparity in safety or effectiveness, with respect to a drug or biological product, includes—

(1) evidence that there is a disparity on the basis of racial or ethnic background as to safety or effectiveness of a drug or biological product in the same chemical class as the drug or biological product;

(2) evidence that there is a disparity on the basis of racial or ethnic background in the way the drug or biological product is metabolized; and

(3) other evidence as the Secretary may determine appropriate.

(b) Enforcement. Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

Text this section adds to the law

(hh) If it is a drug and the holder of the approved application under section 505 or license under section 351 of the Public Health Service Act for the drug has failed to complete the investigations or studies required under section 505H, or comply with any other requirement of such section 505H.

(c) Drug fees. Section 736(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)(A)(ii)) is amended by inserting after are not required the following: , including postmarket studies required under section 505H,.

II Culturally and linguistically appropriate health and health care

III Health workforce diversity

A Diversifying the health care workplace

B Substance Use Disorder Treatment and Behavioral and Mental Health Workforce

C ACCESS in Mental Health Act

D Developing the Community Health Workforce Act

IV Improving Health Care Access and Quality

A Reducing Barriers to Accessing Care

B Improvement of Coverage

C Expansion of Access

1 General Provisions

2 Rural

3 Indian Communities

4 Providers

5 Dental

D Advancing Health Equity Through Payment and Delivery Reform

E Health Empowerment Zones

F Equitable Health Care for All

G Investing in Equity

H Miscellaneous

I Territories Health Equity

1 Medicare

A Part A

B Part B

C Medicare Advantage (Part C)

D Part D

2 Miscellaneous

V Improving health outcomes for women, gender-diverse people, children, and families

A Underserved communities

B Pregnancy screening

C Pregnancy-Related care

D Federal agency coordination on maternal health

E Reproductive and Sexual Health

F Children’s Health

G Elder Care

H Miscellaneous provisions

VI Mental health and substance use disorders

A Access to care and funding streams

B Interprofessional care

C Workforce development

D Children’s mental health

E Community-Based care

F Reports

G Miscellaneous provisions

VII Addressing high-impact minority diseases

A Cancer

B Viral hepatitis and liver cancer control and prevention

C Acquired bone marrow failure diseases

D Cardiovascular disease, chronic disease, obesity, and other disease issues

E HIV/AIDS

F Diabetes

G Lung disease

H Tuberculosis

I Osteoarthritis and Musculoskeletal Diseases

J Sleep and circadian rhythm disorders

K Kidney disease research, surveillance, prevention, and treatment

L Diversity in clinical trials

M Additional provisions addressing high-impact minority diseases

N Health Equity and Rare Disease Act

O Asunción Valdivia Heat Illness, Injury, and Fatality Prevention

P New Era of Preventing End-Stage Kidney Disease

VIII Health Information Technology

A Reducing Health Disparities Through Health IT

B Modifications To Achieve Parity in Existing Programs

C Additional Research and Studies

D Closing Gaps in Funding To Adopt Certified EHRs

E Expanding Access to Telehealth Services

IX Accountability and Evaluation

X Addressing Social Determinants and Improving Environmental Justice

A In General

B Gun Violence

C Nutrition for women, children, families

1 Senior hunger prevention

2 Closing the meal gap

D Universal school meals

1 School breakfast program

2 School lunch program

3 Elementary and secondary education data

4 Amendments to other programs and laws

XI Protections to combat regulatory harm to health equity