[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                    (A) In a draft guidance issued in January 2004, the 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>