I 
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 contracep-
tion 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. SA´NCHEZ 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 regula-
tion 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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Scientific Fair-
ness for Women Act’’. 
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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 re-
ported 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 sec-
ond 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(A) In a draft guidance issued in January 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 mi-
gration resulting from ruptures; and 
(iii) to characterize the health con-
sequences of ruptures and associated mi-
gration. 
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(B) The manufacturers of silicone breast 
implants have not complied with that draft 
guidance for the specific implants in their pre-
market-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 estab-
lished whether the implants in their premarket- 
approval applications would have similar or dif-
ferent failure rates and leakage after 17 years. 
(D) In April 2005, a study published in 
the American Journal of Surgical Pathology fo-
cusing 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. 
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(E) In 2003, the U.S. government entered 
into a settlement with breast implant manufac-
turers for reimbursement for medical expenses 
paid by the Federal Government for women 
harmed by silicone gel breast implants. 
(F) FDA’s Office of Criminal Investiga-
tions (‘‘OCI’’) has investigated whether one 
manufacturer of breast implants submitted in-
accurate 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 Ad-
junct 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 ap-
plication in May 2004 because of concerns that 
easier access to Plan B might result in in-
creased 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 
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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 Of-
fice 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 re-
jected to ‘‘appease the administration’s con-
stituents’’. 
(E) In a letter and congressional testimony 
on August 1, the FDA Commissioner rec-
ommended that the appropriate age range for 
over-the-counter Plan B is 18 and older. This 
recommendation was established arbitrarily and 
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acknowledged by FDA as not supported by sci-
entific 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 with-
out 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 emer-
gency contraception ‘‘was unusual’’ in that the 
decision was made at a much higher level with-
in 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— 
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(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 in-
serting ‘‘subsection (g)’’; and 
(3) by inserting after subsection (e) the fol-
lowing 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 wom-
en’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.’’. 
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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 amend-
ed 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 sec-
tion 515(d)(2) unless the applicant involved has estab-
lished the lifetime of the implant, and demonstrates, prior 
to approval of the application, that safety has been dem-
onstrated for the life of the implant. 
‘‘(b) CERTAIN PRODUCT REQUIREMENTS.—In ap-
proving an application under section 515 for a breast im-
plant, 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 im-
plant shall be clearly defined in all materials, including 
labeling, patient information, and marketing materials. 
‘‘(c) REPORT
TO
CONGRESS
REGARDING
AP-
PROVAL.—Not later than 30 days after approving an ap-
plication under section 515 regarding a breast implant, 
the Secretary shall submit to the Congress a report that 
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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 sub-
committee or panel thereof) that considers issues con-
cerning breast implants, the following applies: 
‘‘(1) The Secretary may not grant any exemp-
tions for conflicts related to personal financial inter-
ests. 
‘‘(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 edu-
cational background of the individual. 
‘‘(3) The individual may not serve at any meet-
ing 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, ana-
lyzing the platinum found in silicone gel breast implants 
in vivo as well as levels and ionization found in the wom-
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en’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 sci-
entists, 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 im-
planted to augment or reconstruct the female breast that 
contains a filler material comprised of a substance or sub-
stances 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 con-
vene 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 
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(2) include among the participants in the work-
shop— 
(A) scientific and clinical representatives 
from the American Academy of Pediatrics, the 
American College of Obstetricians and Gyne-
cologists, 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 contracep-
tives, including emergency contraceptives, by 
women under the age of 18; and 
(C) the appropriate review divisions of the 
Food and Drug Administration and the profes-
sional scientific and clinical staff within such 
divisions. 
Æ 
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