Wednesday, April 3, 2013

Obamacare (1) - FOOD AND DRUG ADMINISTRATION OFFICE OF WOMEN’S HEALTH


Think you know Obamacare? Think again. There is an old saying - knowledge is a dangerous thing. So be it. I got the full text of the law here:
http://www.healthcare.gov/law/full/index.html (opens a PDF)
This puppy is 974 pages long. I vow to read the whole dadgum thing and post the more interesting bits right here, so stay tuned.

Here is the first installment (in particular, not section (i)):

(g) FOOD AND DRUG ADMINISTRATION OFFICE OF WOMEN’S
HEALTH.—Chapter X of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 391 et seq.) is amended by adding at the end the following:
‘‘SEC. 1011 ø21 U.S.C. 399b¿. OFFICE OF WOMEN’S HEALTH.
‘‘(a) ESTABLISHMENT.—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) PURPOSE.—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 in-
clusion 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 229(b)(4) of the Public Health Service
Act).
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—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.’’.
(h) NO NEW REGULATORY AUTHORITY.—Nothing in this section
and the amendments made by this section may be construed as establishing
regulatory authority or modifying any existing regulatory
authority.
(i) LIMITATION ON TERMINATION.—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 shall not be terminated, reorganized, or
have any of it’s powers or duties transferred unless such termination,
reorganization, or transfer is approved by Congress through
the adoption of a concurrent resolution of approval.

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