21 U.S.C. § 399b — Office of Women’s Health
submitted 88 years ago by Pub. L. 111-148 to r/title-21-FOOD-AND-DRUGS · 291 words · no verdicts yet
The FDA must run an Office of Women's Health, led by a director the Commissioner appoints. This office studies how well women are included in drug and device testing. It sets goals, shares health information, and estimates the funding needed each year.
(a) Establishment
The FDA must create an Office of Women's Health inside the Office of the Commissioner*. The Commissioner of Food* and Drugs appoints a director to lead it.
(b) Purpose
The director must report to the Commissioner on how well the FDA includes women in clinical trials, and how well it analyzes drug*, device, and biological product data by sex — across different ages, biology, and social backgrounds.
The director must set short-term and long-term goals for women's health issues that the FDA oversees. This includes making sure FDA rules and policies properly include women and analyze data by sex, where that matters.
The director must give women and health care providers information about known differences between men and women's health.
The director must consult with drug, biologics, and device makers; health professionals who know women's health issues; consumer groups; and women's health experts, about FDA policy toward women.
Each year, the director must estimate how much money is needed to monitor clinical trials and sex-based data analysis, based on identified needs.
The director must also serve on the Department* of Health and Human Services' Coordinating Committee on Women's Health.
(c) Authorization of appropriations
Congress may fund this section with whatever money is necessary, for fiscal years 2010 through 2014.
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.
The Director of the Office shall—
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;
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;
provide information to women and health care providers on those areas in which differences between men and women exist;
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;
make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and
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).
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.
Source credit: (June 25, 1938, ch. 675, § 1011, as added Pub. L. 111–148, title III, § 3509(g), Mar. 23, 2010, 124 Stat. 536.)
- 1938Enacted · Pub. L. 111-148 · 124 Stat. 536
A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-148 on 1938-06-25.
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