FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA).
Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a class III device for a breast implant unless the applicant involved has established the lifetime of the implant and demonstrates that safety has been demonstrated for the life of the implant. Requires the Secretary to determine appropriate clinical care and removal and replacement requirements for the implant, including appropriate coverage by government health care systems.
Sets forth provisions governing any FDA advisory committee that considers issues concerning breast implants, including that the Secretary may not grant any exemption for conflicts related to personal financial interests.
Requires the Secretary to: (1) provide for a study on the ionization and levels of platinum in silicone breast implants; and (2) establish a panel of independent scientists for the purpose of designing and conducting the study.
Requires the Secretary, acting through the Commissioner of Food and Drugs, to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by females of childbearing potential under the age of 18, including scientific questions identified in the recent limited approval of Plan B emergency contraception.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6235 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 6235
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
Office of Women's Health and the regulation of breast implants, and to
provide for a scientific workshop on the use of emergency contraception
by women under age 18.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 28, 2006
Ms. DeLauro (for herself, Mr. Hinchey, Mr. Conyers, Ms. Jackson-Lee of
Texas, Mrs. Davis of California, Ms. Solis, Mr. McDermott, Ms. Linda T.
Sanchez of California, Mr. Stark, Mr. Moran of Virginia, Mr. Grijalva,
and Mrs. Capps) introduced the following bill; which was referred to
the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
Office of Women's Health and the regulation of breast implants, and to
provide for a scientific workshop on the use of emergency contraception
by women under age 18.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Scientific Fairness for Women
Act''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) With respect to the Office of Women's Health within the
Food and Drug Administration:
(A) When first established, the Office reported
directly to the Commissioner of Food and Drugs.
(B) In the current organization of the Food and
Drug Administration (``FDA''), the Office of Women's
Health is located at the second level reporting within
the Office of the Commissioner and is within the Office
of Science and Health Coordination.
(2) With respect to the regulation by the FDA of silicone
breast implants:
(A) In a draft guidance issued in January 2004, the
FDA asked manufacturers of such implants--
(i) to describe the rates of implant
rupture over the lifetime of the product;
(ii) to describe the incidence of gel
migration resulting from ruptures; and
(iii) to characterize the health
consequences of ruptures and associated
migration.
(B) The manufacturers of silicone breast implants
have not complied with that draft guidance for the
specific implants in their premarket-approval
applications.
(C) A study released by FDA researchers in 2000
reviewed silicone breast implants that were an average
age of 17 years and concluded that 69 percent of the
women had ruptures in one or more silicone breast
implants, and 21 percent experienced gel migration
outside the implant. Implant manufacturers have not
established whether the implants in their premarket-
approval applications would have similar or different
failure rates and leakage after 17 years.
(D) In April 2005, a study published in the
American Journal of Surgical Pathology focusing on gel
migration found that 90 percent of the women studied
who had silicone implants showed silicone droplets in
their lymph nodes. The study also showed that 95
percent of these women had abnormal cells in their
lymph nodes, compared with only 33 percent of women who
had breast cancer surgery without the addition of
silicone implants.
(E) In 2003, the U.S. government entered into a
settlement with breast implant manufacturers for
reimbursement for medical expenses paid by the Federal
Government for women harmed by silicone gel breast
implants.
(F) FDA's Office of Criminal Investigations
(``OCI'') has investigated whether one manufacturer of
breast implants submitted inaccurate data on ruptures
in its application. The FDA OCI also is investigating
allegations regarding whether that same manufacturer
failed to ensure that their implants were used in
compliance with FDA restrictions for the Adjunct Study.
(3) With respect to the applications submitted to the FDA
by Barr Laboratories for approval of the contraceptive drug
marketed as Plan B:
(A) The FDA rejected the first Plan B application
in May 2004 because of concerns that easier access to
Plan B might result in increased promiscuity among
women under 16, despite studies disproving this
contention.
(B) The FDA said it would not approve the Plan B
application unless it included an age-based sales
distinction. In response, Barr Laboratories submitted a
new application to provide over-the-counter sales of
plan B to women 16 years and older. More than one-year
later, FDA expressed concern that the age-based sales
distinction would present regulatory concerns, even
though the amended application was the result of FDA's
recommendations.
(C) According to court documents released on August
3, 2006, the director of FDA's Office of New Drugs
learned early in 2004 that the then-FDA Commissioner
had decided against approval of Plan B before FDA staff
could complete their analysis.
(D) In another sworn deposition contained in the
same court documents, one FDA official was told in
January 2004 by the FDA Deputy Commissioner that Plan B
needed to be rejected to ``appease the administration's
constituents''.
(E) In a letter and congressional testimony on
August 1, the FDA Commissioner recommended that the
appropriate age range for over-the-counter Plan B is 18
and older. This recommendation was established
arbitrarily and acknowledged by FDA as not supported by
scientific data.
(F) A former FDA Commissioner testified in a sworn
statement that he delayed approving over-the-counter
sales of Plan B to determine how to restrict sales to
young teens.
(G) A study in the Journal of Obstetrics &
Gynecology concluded that young women are able to use
Plan B ``effectively and safely without health care
provider intervention''.
(H) In November 2005, the Governmental
Accountability Office found that the May 2004 decision
to deny OTC status to Plan B emergency contraception
``was unusual'' in that the decision was made at a much
higher level within FDA than is usual practice, that
the decision overruled recommendations by several
levels of professional staff, and that the decision to
limit OTC access to only those over a certain age was
made prior to the completion of the regular review
process.
SEC. 3. OFFICE OF WOMEN'S HEALTH WITHIN FOOD AND DRUG ADMINISTRATION.
Section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
392) is amended--
(1) by redesignating subsections (f) and (g) as subsections
(g) and (h), respectively;
(2) in subsection (g) (as so redesignated), in paragraph
(1), by striking ``subsection (f)'' and inserting ``subsection
(g)''; and
(3) by inserting after subsection (e) the following
subsection:
``(f) Office of Women's Health.--
``(1) In general.--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 subsection as the
`Office'). The Office shall be headed by a director, who shall
report directly to the Commissioner.
``(2) Duties.--With respect to activities of the Food and
Drug Administration that relate to women's health, the Director
of the Office shall--
``(A) assess the level of agency activity;
``(B) set short-range and long-range goals; and
``(C) be responsible for activities related to
prevention, research, education and training, service
delivery, and policy development.''.
SEC. 4. SCIENCE ON BREAST IMPLANTS.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515
the following section:
``SEC. 515A. BREAST IMPLANTS.
``(a) Demonstration of Safety for Life of the Device.--In the case
of an application under section 515 for a breast implant, the Secretary
shall not find that a reasonable assurance of safety has been shown
under section 515(d)(2) unless the applicant involved has established
the lifetime of the implant, and demonstrates, prior to approval of the
application, that safety has been demonstrated for the life of the
implant.
``(b) Certain Product Requirements.--In approving an application
under section 515 for a breast implant, the Secretary shall determine
appropriate clinical care and removal and replacement requirements for
the implant, including appropriate coverage by government health care
systems. In addition, the life of the implant and follow-up care and
removal requirements of the implant shall be clearly defined in all
materials, including labeling, patient information, and marketing
materials.
``(c) Report to Congress Regarding Approval.--Not later than 30
days after approving an application under section 515 regarding a
breast implant, the Secretary shall submit to the Congress a report
that summarizes the findings of the Secretary with respect to the
safety and effectiveness of the implant, including the finding under
subsection (a).
``(d) Breast Implant Advisory Committees.--With respect to
membership on any advisory committee of the Food and Drug
Administration (including any subcommittee or panel thereof) that
considers issues concerning breast implants, the following applies:
``(1) The Secretary may not grant any exemptions for
conflicts related to personal financial interests.
``(2) Before adding a member to the committee, the
Secretary shall post a notice on the Internet site of such
Administration that the individual involved will become a
member of the committee. The notice shall include a summary of
the professional and educational background of the individual.
``(3) The individual may not serve at any meeting of the
committee until 30 days after the notice is posted on such
site.
``(e) Study on the Ionization of Platinum.--The Secretary shall
provide for a study on the ionization and levels of platinum in
silicone breast implants, analyzing the platinum found in silicone gel
breast implants in vivo as well as levels and ionization found in the
women's tissues, breast milk, and other bodily fluids. The study shall
also report the potential short-term and long-term risks of the
presence of platinum or platinum salts. The Secretary shall establish a
panel of independent scientists, including scientists from the Centers
for Disease Control and Prevention and the National Institutes of
Health, for the purpose of designing and conducting the study.
``(f) Definition.--For purposes of this section, the term `breast
implant' means a device intended to be implanted to augment or
reconstruct the female breast that contains a filler material comprised
of a substance or substances other than sterile isotonic saline.''.
SEC. 5. SCIENTIFIC WORKSHOP ON USE OF EMERGENCY CONTRACEPTION BY WOMEN
UNDER AGE 18.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall convene a scientific workshop
within six months after the date of the enactment of this Act to review
and evaluate current scientific data on the use of emergency
contraception by females of childbearing potential under the age of 18.
The scientific workshop shall--
(1) address the scientific questions identified in the
recent limited approval of Plan B emergency contraception; and
(2) include among the participants in the workshop--
(A) scientific and clinical representatives from
the American Academy of Pediatrics, the American
College of Obstetricians and Gynecologists, the Society
of Adolescent Medicine, the American Medical
Association, the National Institutes of Health, and the
Agency for Healthcare Research and Quality;
(B) scientific and clinical researchers who have
carried out research on use of contraceptives,
including emergency contraceptives, by women under the
age of 18; and
(C) the appropriate review divisions of the Food
and Drug Administration and the professional scientific
and clinical staff within such divisions.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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