I 
110TH CONGRESS 
1ST SESSION H. R. 2503 
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 
MAY 24, 2007 
Ms. DELAURO (for herself, Ms. SOLIS, Mr. FARR, Ms. WOOLSEY, Mr. 
GRIJALVA, Mr. WEXLER, Mrs. NAPOLITANO, Ms. SCHAKOWSKY, Ms. 
SUTTON, and Mr. RUSH) 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(A) In a draft guidance issued in January 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 FDA approved silicone gel breast 
implants in November 2006 despite the lack of 
data responding to those three essential ques-
tions. 
(C) A study published by FDA researchers 
in 2001, using magnetic resonance imaging 
(MRI) to analyze women whose silicone gel 
breast implants were an average of 17 years old 
found that 69 percent of the women had rup-
tures in one or both silicone breast implants, 
and 21 percent experienced gel migration out-
side the scar capsule surrounding the implant. 
Implant manufacturers have not established 
whether the implants in their premarket-ap-
proval applications would have similar or dif-
ferent failure rates and leakage. 
(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 in their lymph nodes. The study 
also showed that 95 percent of these women 
had abnormal cells in their lymph nodes, com-
pared with only 33 percent of women who had 
breast cancer surgery but did not have silicone 
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implants. The Secretary of Health and Human 
Services has not provided enforceable conditions 
to ensure that women are not harmed by leak-
ing silicone from their breast implants. 
(E) In 2003, the United States Govern-
ment entered into a settlement with breast im-
plant manufacturers for reimbursement for 
medical expenses paid by the Government for 
women harmed by silicone gel breast implants. 
No information has been made public about the 
use of those funds to provide health care or dis-
ability benefits for women harmed by breast im-
plants. 
(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 
Laboratories submitted a new application to 
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