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 contraception 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 regulation of breast implants, and to provide for a scientific 

workshop on the use of emergency contraception by 

women under age 18. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Scientific Fair5 ness for Women Act’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) With respect to the Office of Women’s 

4 Health within the Food and Drug Administration: 

5 (A) When first established, the Office re6 ported directly to the Commissioner of Food 

7 and Drugs. 

8 (B) In the current organization of the 

9 Food and Drug Administration (‘‘FDA’’), the 

10 Office of Women’s Health is located at the sec11 ond level reporting within the Office of the 

12 Commissioner and is within the Office of 

13 Science and Health Coordination. 

14 (2) With respect to the regulation by the FDA 

15 of silicone breast implants: 

16 (A) In a draft guidance issued in January 

17 2004, the FDA asked manufacturers of such 

18 implants— 

19 (i) to describe the rates of implant 

20 rupture over the lifetime of the product; 

21 (ii) to describe the incidence of gel mi22 gration resulting from ruptures; and 

23 (iii) to characterize the health con24 sequences of ruptures and associated mi25 gration. 


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1 (B) The FDA approved silicone gel breast 

2 implants in November 2006 despite the lack of 

3 data responding to those three essential ques4 tions. 

5 (C) A study published by FDA researchers 

6 in 2001, using magnetic resonance imaging 

7 (MRI) to analyze women whose silicone gel 

8 breast implants were an average of 17 years old 

9 found that 69 percent of the women had rup10 tures in one or both silicone breast implants, 

11 and 21 percent experienced gel migration out12 side the scar capsule surrounding the implant. 

13 Implant manufacturers have not established 

14 whether the implants in their premarket-ap15 proval applications would have similar or dif16 ferent failure rates and leakage. 

17 (D) In April 2005, a study published in 

18 the American Journal of Surgical Pathology fo19 cusing on gel migration found that 90 percent 

20 of the women studied who had silicone implants 

21 showed silicone in their lymph nodes. The study 

22 also showed that 95 percent of these women 

23 had abnormal cells in their lymph nodes, com24 pared with only 33 percent of women who had 

25 breast cancer surgery but did not have silicone 


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1 implants. The Secretary of Health and Human 

2 Services has not provided enforceable conditions 

3 to ensure that women are not harmed by leak4 ing silicone from their breast implants. 

5 (E) In 2003, the United States Govern6 ment entered into a settlement with breast im7 plant manufacturers for reimbursement for 

8 medical expenses paid by the Government for 

9 women harmed by silicone gel breast implants. 

10 No information has been made public about the 

11 use of those funds to provide health care or dis12 ability benefits for women harmed by breast im13 plants. 

14 (3) With respect to the applications submitted 

15 to the FDA by Barr Laboratories for approval of 

16 the contraceptive drug marketed as Plan B: 

17 (A) The FDA rejected the first Plan B ap18 plication in May 2004 because of concerns that 

19 easier access to Plan B might result in in20 creased promiscuity among women under 16, 

21 despite studies disproving this contention. 

22 (B) The FDA said it would not approve 

23 the Plan B application unless it included an 

24 age-based sales distinction. In response, Barr 

25 Laboratories submitted a new application to 


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1 provide over-the-counter sales of plan B to 

2 women 16 years and older. More than one year 

3 later, FDA expressed concern that the age4 based sales distinction would present regulatory 

5 concerns, even though the amended application 

6 was the result of FDA’s recommendations. 

7 (C) According to court documents released 

8 on August 3, 2006, the director of FDA’s Of9 fice of New Drugs learned early in 2004 that 

10 the then-FDA Commissioner had decided 

11 against approval of Plan B before FDA staff 

12 could complete their analysis. 

13 (D) In another sworn deposition contained 

14 in the same court documents, one FDA official 

15 was told in January 2004 by the FDA Deputy 

16 Commissioner that Plan B needed to be re17 jected to ‘‘appease the administration’s con18 stituents’’. 

19 (E) In a letter and congressional testimony 

20 on August 1, the FDA Commissioner rec21 ommended that the appropriate age range for 

22 over-the-counter Plan B is 18 and older. This 

23 recommendation was established arbitrarily and 

24 acknowledged by FDA as not supported by sci25 entific data. 


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1 (F) A former FDA Commissioner testified 

2 in a sworn statement that he delayed approving 

3 over-the-counter sales of Plan B to determine 

4 how to restrict sales to young teens. 

5 (G) A study in the Journal of Obstetrics & 

6 Gynecology concluded that young women are 

7 able to use Plan B ‘‘effectively and safely with8 out health care provider intervention’’. 

9 (H) In November 2005, the Government 

10 Accountability Office found that the May 2004 

11 decision to deny OTC status to Plan B emer12 gency contraception ‘‘was unusual’’ in that the 

13 decision was made at a much higher level with14 in FDA than is usual practice, that the decision 

15 overruled recommendations by several levels of 

16 professional staff, and that the decision to limit 

17 OTC access to only those over a certain age 

18 was made prior to the completion of the regular 

19 review process. 

20 SEC. 3. OFFICE OF WOMEN’S HEALTH WITHIN FOOD AND 

21 DRUG ADMINISTRATION. 

22 (a) ESTABLISHMENT.—Section 903 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 392) is amend24 ed— 


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1 (1) by redesignating subsections (f) and (g) as 

2 subsections (g) and (h), respectively; 

3 (2) in subsection (h) (as so redesignated), in 

4 paragraph (1), by striking ‘‘subsection (f)’’ and in5 serting ‘‘subsection (g)’’; and 

6 (3) by inserting after subsection (e) the fol7 lowing subsection: 

8 ‘‘(f) OFFICE OF WOMEN’S HEALTH.— 

9 ‘‘(1) IN GENERAL.—There is established within 

10 the Office of the Commissioner an office to be 

11 known as the Office of Women’s Health (referred to 

12 in this subsection as the ‘Office’). The Office shall 

13 be headed by a director, who shall report directly to 

14 the Commissioner. 

15 ‘‘(2) DUTIES.—With respect to activities of the 

16 Food and Drug Administration that relate to wom17 en’s health, the Director of the Office shall— 

18 ‘‘(A) assess the level of agency activity; 

19 ‘‘(B) set short-range and long-range goals; 

20 and 

21 ‘‘(C) be responsible for activities related to 

22 prevention, research, education and training, 

23 service delivery, and policy development.’’. 

24 (b) PROHIBITION AGAINST TRANSFER OF FUNDS.— 

25 Notwithstanding any other provision of law authorizing 


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1 the transfer of funds within the Department of Health and 

2 Human Services or within the Food and Drug Administra3 tion, any funds appropriated for the Office of Women’s 

4 Health within the Food and Drug Administration shall not 

5 be transferred to any other agency or office. 

6 SEC. 4. SCIENCE ON BREAST IMPLANTS. 

7 (a) CLASSIFICATION OF BREAST IMPLANTS.—Section 

8 513(f) of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 360c(f)) is amended by adding at the end the fol10 lowing: 

11 ‘‘(6) A breast implant (as such term is defined in sec12 tion 515A(f)) is deemed to be a class III device and shall 

13 be required to have an approval under section 515 of an 

14 application for premarket approval. This paragraph ap15 plies to a breast implant irrespective of whether the im16 plant has been cleared under section 510(k) before the 

17 date of the enactment of this paragraph.’’. 

18 (b) DEMONSTRATION OF SAFETY.—Subchapter A of 

19 chapter V of the Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 351 et seq.) is amended by inserting after sec21 tion 515 the following section: 

22 ‘‘SEC. 515A. BREAST IMPLANTS. 

23 ‘‘(a) DEMONSTRATION OF SAFETY FOR LIFE OF THE

24 DEVICE.— 


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1 ‘‘(1) IN GENERAL.—In the case of an applica2 tion for a breast implant filed under section 515, the 

3 Secretary shall not find that a reasonable assurance 

4 of safety has been shown under section 515(d)(2) 

5 unless, prior to the approval of the application, the 

6 applicant involved has established— 

7 ‘‘(A) the life of the implant; and 

8 ‘‘(B) that safety has been demonstrated 

9 for the life of the implant. 

10 ‘‘(2) PREVIOUSLY APPROVED APPLICATIONS.— 

11 In the case of an application for a breast implant 

12 approved under section 515 before the date of the 

13 enactment of this section, the breast implant is 

14 deemed to be unsafe for purposes of section 

15 515(e)(1)(A), and the Secretary shall withdraw ap16 proval of the application for such breast implant 

17 under section 515(e), unless the holder of the appli18 cation establishes the life of the implant and dem19 onstrates that safety has been demonstrated for the 

20 life of the implant. 

21 ‘‘(b) GUIDANCE FOR CLINICAL CARE, REMOVAL AND

22 REPLACEMENT.— 

23 ‘‘(1) IN GENERAL.—In approving an application 

24 for a breast implant under section 515, the Sec25 retary shall— 


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1 ‘‘(A) issue appropriate, voluntary guidance 

2 for clinical care, removal, and replacement for 

3 the implant, including appropriate coverage by 

4 government health care systems; and 

5 ‘‘(B) require such guidance to be clearly 

6 expressed in the labeling and all marketing ma7 terials for such implant. 

8 ‘‘(2) PREVIOUSLY APPROVED APPLICATIONS.— 

9 In the case of each application for a breast implant 

10 approved under section 515 before the date of the 

11 enactment of this section, the Secretary shall— 

12 ‘‘(A) not later than 90 days after such 

13 date of enactment, issue guidance for the im14 plant in accordance with paragraph (1)(A); 

15 ‘‘(B) require such guidance to be clearly 

16 expressed in the labeling and all marketing ma17 terials for the implant; and 

18 ‘‘(C) require dissemination of such guid19 ance to patients who received the implant be20 fore the inclusion of such guidance into the la21 beling for the implant. 

22 ‘‘(c) REPORTS TO CONGRESS.— 

23 ‘‘(1) REQUIREMENT.—On an annual basis, the 

24 Secretary shall submit to the Congress a report that 

25 summarizes the progress of postmarket studies and 


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1 findings with respect to the safety and effectiveness 

2 of each breast implant approved under section 515, 

3 including the findings on safety for the life of the 

4 implant under subsection (a). 

5 ‘‘(2) FIRST REPORT.—The Secretary shall sub6 mit the first report under this subsection for a 

7 breast implant not later than— 

8 ‘‘(A) 120 days after approving an applica9 tion for the implant under section 515; or 

10 ‘‘(B) if an application for the implant was 

11 approved under section 515 before the date of 

12 the enactment of this section, 120 days after 

13 such date of enactment. 

14 ‘‘(d) BREAST IMPLANT ADVISORY PANELS.— 

15 ‘‘(1) REVIEW OF 10-YEAR LONGITUDINAL STUD16 IES.—The Breast Implant Advisory Panel of the 

17 General and Plastic Surgery Advisory Committee of 

18 the Food and Drug Administration shall meet— 

19 ‘‘(A) in 2007 to review the results and 

20 quality of the research under the 10-year longi21 tudinal studies required by the Food and Drug 

22 Administration for saline breast implants ap23 proved under section 515; and 

24 ‘‘(B) in each of 2008 and 2009 to review 

25 the progress of the 10-year longitudinal studies 


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1 required by the Food and Drug Administration 

2 for silicone gel breast implants approved under 

3 section 515. 

4 ‘‘(2) MEMBERSHIP.—With respect to member5 ship on any advisory committee of the Food and 

6 Drug Administration (including any subcommittee 

7 or panel thereof) that considers issues concerning 

8 breast implants, the following applies: 

9 ‘‘(A) The Secretary may not grant any ex10 emptions for conflicts related to personal finan11 cial interests. 

12 ‘‘(B) Before adding a member to the com13 mittee, the Secretary shall post a notice on the 

14 Internet site of such Administration that the in15 dividual involved will become a member of the 

16 committee. The notice shall include a summary 

17 of the professional and educational background 

18 of the individual. 

19 ‘‘(C) The individual may not serve at any 

20 meeting of the committee until 30 days after 

21 the notice is posted on such site. 

22 ‘‘(e) STUDY ON THE IONIZATION OF PLATINUM.— 

23 ‘‘(1) IN GENERAL.—Not later than 365 days 

24 after the date of the enactment of this section, the 


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1 Secretary shall complete a study and submit a re2 port to the Congress on— 

3 ‘‘(A) the ionization and levels of platinum 

4 in silicone breast implants, analyzing the plat5 inum found in silicone gel breast implants in 

6 vivo as well as levels and ionization found in 

7 women’s tissues, breast milk, and other bodily 

8 fluids; and 

9 ‘‘(B) the potential short-term and long10 term risks of the presence of platinum or plat11 inum salts. 

12 ‘‘(2) PANEL OF INDEPENDENT SCIENTISTS.— 

13 The Secretary shall establish a panel of independent 

14 scientists, including scientists from the Centers for 

15 Disease Control and Prevention and the National In16 stitutes of Health, for the purpose of designing and 

17 conducting the study under this subsection. No sci18 entist with financial ties to a breast implant com19 pany, silicone company, or plastic surgeon shall 

20 serve on such panel or participate in the design or 

21 conduct of such studies. 

22 ‘‘(f) DEFINITION.—For purposes of this section, the 

23 term ‘breast implant’ means a device intended to be im24 planted to augment or reconstruct the female breast that, 

25 except as provided in subsection (d)(1)(A), contains a filler 


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1 material comprised of a substance or substances other 

2 than sterile isotonic saline.’’. 

3 SEC. 5. SCIENTIFIC WORKSHOP ON USE OF EMERGENCY 

4 CONTRACEPTION BY WOMEN UNDER AGE 18. 

5 The Secretary of Health and Human Services, acting 

6 through the Commissioner of Food and Drugs, shall con7 vene a scientific workshop within six months after the date 

8 of the enactment of this Act to review and evaluate current 

9 scientific data on the use of emergency contraception by 

10 females of childbearing potential under the age of 18. The 

11 scientific workshop shall— 

12 (1) address the scientific questions identified in 

13 the recent limited approval of Plan B emergency 

14 contraception; and 

15 (2) include among the participants in the work16 shop— 

17 (A) scientific and clinical representatives 

18 from the American Academy of Pediatrics, the 

19 American College of Obstetricians and Gyne20 cologists, the Society of Adolescent Medicine, 

21 the American Medical Association, the National 

22 Institutes of Health, and the Agency for 

23 Healthcare Research and Quality; 

24 (B) scientific and clinical researchers who 

25 have carried out research on use of contracepVerDate Aug 31 2005 22:05 May 29, 2007 Jkt 059196 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H2503.IH H2503

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1 tives, including emergency contraceptives, by 

2 women under the age of 18; and 

3 (C) the appropriate review divisions of the 

4 Food and Drug Administration and the profes5 sional scientific and clinical staff within such 

6 divisions. 

Æ 


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