[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2503 Introduced in House (IH)]







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.

    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                    (A) In a draft guidance issued in January 2004, the 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 FDA approved silicone gel breast implants 
                in November 2006 despite the lack of data responding to 
                those three essential questions.
                    (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 
                ruptures in one or both silicone breast implants, and 
                21 percent experienced gel migration outside the scar 
                capsule surrounding the implant. Implant manufacturers 
                have not established whether the implants in their 
                premarket-approval applications would have similar or 
                different failure rates and leakage.
                    (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 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 but did not have silicone implants. The 
                Secretary of Health and Human Services has not provided 
                enforceable conditions to ensure that women are not 
                harmed by leaking silicone from their breast implants.
                    (E) In 2003, the United States Government entered 
                into a settlement with breast implant 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 disability 
                benefits for women harmed by breast implants.
            (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 Government 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.

    (a) Establishment.--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 (h) (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.''.
    (b) Prohibition Against Transfer of Funds.--Notwithstanding any 
other provision of law authorizing the transfer of funds within the 
Department of Health and Human Services or within the Food and Drug 
Administration, any funds appropriated for the Office of Women's Health 
within the Food and Drug Administration shall not be transferred to any 
other agency or office.

SEC. 4. SCIENCE ON BREAST IMPLANTS.

    (a) Classification of Breast Implants.--Section 513(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)) is amended by 
adding at the end the following:
    ``(6) A breast implant (as such term is defined in section 515A(f)) 
is deemed to be a class III device and shall be required to have an 
approval under section 515 of an application for premarket approval. 
This paragraph applies to a breast implant irrespective of whether the 
implant has been cleared under section 510(k) before the date of the 
enactment of this paragraph.''.
    (b) Demonstration of Safety.--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.--
            ``(1) In general.--In the case of an application for a 
        breast implant filed under section 515, the Secretary shall not 
        find that a reasonable assurance of safety has been shown under 
        section 515(d)(2) unless, prior to the approval of the 
        application, the applicant involved has established--
                    ``(A) the life of the implant; and
                    ``(B) that safety has been demonstrated for the 
                life of the implant.
            ``(2) Previously approved applications.--In the case of an 
        application for a breast implant approved under section 515 
        before the date of the enactment of this section, the breast 
        implant is deemed to be unsafe for purposes of section 
        515(e)(1)(A), and the Secretary shall withdraw approval of the 
        application for such breast implant under section 515(e), 
        unless the holder of the application establishes the life of 
        the implant and demonstrates that safety has been demonstrated 
        for the life of the implant.
    ``(b) Guidance for Clinical Care, Removal and Replacement.--
            ``(1) In general.--In approving an application for a breast 
        implant under section 515, the Secretary shall--
                    ``(A) issue appropriate, voluntary guidance for 
                clinical care, removal, and replacement for the 
                implant, including appropriate coverage by government 
                health care systems; and
                    ``(B) require such guidance to be clearly expressed 
                in the labeling and all marketing materials for such 
                implant.
            ``(2) Previously approved applications.--In the case of 
        each application for a breast implant approved under section 
        515 before the date of the enactment of this section, the 
        Secretary shall--
                    ``(A) not later than 90 days after such date of 
                enactment, issue guidance for the implant in accordance 
                with paragraph (1)(A);
                    ``(B) require such guidance to be clearly expressed 
                in the labeling and all marketing materials for the 
                implant; and
                    ``(C) require dissemination of such guidance to 
                patients who received the implant before the inclusion 
                of such guidance into the labeling for the implant.
    ``(c) Reports to Congress.--
            ``(1) Requirement.--On an annual basis, the Secretary shall 
        submit to the Congress a report that summarizes the progress of 
        postmarket studies and findings with respect to the safety and 
        effectiveness of each breast implant approved under section 
        515, including the findings on safety for the life of the 
        implant under subsection (a).
            ``(2) First report.--The Secretary shall submit the first 
        report under this subsection for a breast implant not later 
        than--
                    ``(A) 120 days after approving an application for 
                the implant under section 515; or
                    ``(B) if an application for the implant was 
                approved under section 515 before the date of the 
                enactment of this section, 120 days after such date of 
                enactment.
    ``(d) Breast Implant Advisory Panels.--
            ``(1) Review of 10-year longitudinal studies.--The Breast 
        Implant Advisory Panel of the General and Plastic Surgery 
        Advisory Committee of the Food and Drug Administration shall 
        meet--
                    ``(A) in 2007 to review the results and quality of 
                the research under the 10-year longitudinal studies 
                required by the Food and Drug Administration for saline 
                breast implants approved under section 515; and
                    ``(B) in each of 2008 and 2009 to review the 
                progress of the 10-year longitudinal studies required 
                by the Food and Drug Administration for silicone gel 
                breast implants approved under section 515.
            ``(2) Membership.--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:
                    ``(A) The Secretary may not grant any exemptions 
                for conflicts related to personal financial interests.
                    ``(B) 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.
                    ``(C) 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.--
            ``(1) In general.--Not later than 365 days after the date 
        of the enactment of this section, the Secretary shall complete 
        a study and submit a report to the Congress on--
                    ``(A) 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 women's tissues, breast 
                milk, and other bodily fluids; and
                    ``(B) the potential short-term and long-term risks 
                of the presence of platinum or platinum salts.
            ``(2) Panel of independent scientists.--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 under this subsection. No 
        scientist with financial ties to a breast implant company, 
        silicone company, or plastic surgeon shall serve on such panel 
        or participate in the design or conduct of such studies.
    ``(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, except as provided in subsection 
(d)(1)(A), 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>