§399b — Title 21 Food and Drugs | U.S. Code

Summary

Creates an Office of Women’s Health inside the FDA. A director chosen by the FDA Commissioner will lead the office. The director must report to the Commissioner about how well the FDA includes women in clinical trials and whether data are analyzed by sex, including where useful by age and other factors. The director must set short- and long-term goals for women’s health issues the FDA handles, give information to women and their health care providers about sex differences, consult with drug, biologic, and device makers and with health and consumer experts, make yearly estimates of money needed to monitor trials and sex-based data analysis, and serve on the Department of Health and Human Services Coordinating Committee on Women’s Health. Money needed for these tasks was authorized for each fiscal year from 2010 through 2014.

Title 21, §399b

Food and Drugs — Source: USLM XML via OLRC

(a)There is established within the Office of the Commissioner, an office to be known as the Office of Women’s Health (referred to in this section as the “Office”). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.

(b)The Director of the Office shall—

(1)report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the “Administration”) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;

(2)establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women’s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;

(3)provide information to women and health care providers on those areas in which differences between men and women exist;

(4)consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women’s issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;

(5)make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and

(6)serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of title 42).

(c)For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.

Notes & Related Subsidiaries

Editorial Notes

Codification Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, § 209(a), Jan. 4, 2011, 124 Stat. 3945, and subsequently renumbered section 1012 by Pub. L. 114–255, div. A, title III, § 3073(b)(2), Dec. 13, 2016, 130 Stat. 1137, and is classified to section 399c of this title.

§399b Office of Women’s Health

Summary

Title 21, §399b

Notes & Related Subsidiaries

Editorial Notes

Citations & Metadata