[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4377 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 4377

To provide for the review by the Commissioner of Food and Drugs of the 
process by which the Food and Drug Administration made the decision not 
 to approve the commercial distribution of the emergency-contraceptive 
    drug Plan B as an over-the-counter drug, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 17, 2004

 Mrs. Maloney (for herself, Mr. Grijalva, Mr. Conyers, Mr. Jackson of 
Illinois, Mrs. Capps, Ms. Millender-McDonald, Mr. Lantos, Mr. Crowley, 
  Ms. Jackson-Lee of Texas, Ms. Woolsey, Mr. Nadler, Mr. Filner, Ms. 
 Schakowsky, Mr. Frank of Massachusetts, Ms. Lee, Ms. DeLauro, and Mr. 
    Shays) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To provide for the review by the Commissioner of Food and Drugs of the 
process by which the Food and Drug Administration made the decision not 
 to approve the commercial distribution of the emergency-contraceptive 
    drug Plan B as an over-the-counter drug, and for other purposes.

    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 ``Science Over Politics Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Emergency contraceptive pills (``ECPs'') are approved 
        for use by the Food and Drug Administration (``FDA'').
            (2) Emergency contraceptive pills are a concentrated dosage 
        of ordinary birth control pills that can dramatically reduce a 
        woman's chance of becoming pregnant.
            (3) If ECPs are taken within 72 hours of contraceptive 
        failure or unprotected sex, ECPs can reduce a woman's risk of 
        pregnancy by up to 89 percent.
            (4) Emergency contraceptive pills do not cause abortion but 
        rather prevent pregnancy by inhibiting ovulation, 
        fertilization, or implantation before a pregnancy occurs.
            (5) Emergency contraception cannot interrupt or disrupt an 
        established pregnancy.
            (6) Increased use of ECPs could reduce the number of 
        unintended pregnancies and abortions by half.
            (7) A 2002 study revealed that ECP use was likely 
        responsible for up to 43 percent of the decline in abortions 
        between 1994 and 2000, with ECP use preventing over 50,000 
        abortions in 2000 alone.
            (8) Over-the-counter sales of ECPs would be particularly 
        beneficial for sexual assault victims as approximately 25,000 
        women per year in the United States become pregnant as a result 
        of rape. An estimated 22,000 of these pregnancies, 88 percent, 
        could be prevented if sexual assault victims had timely access 
        to emergency contraception.
            (9) More than 70 organizations, including the American 
        Nurses Association, the American College of Obstetricians and 
        Gynecologists, the American Academy of Pediatrics, the American 
        Medical Association, the American Public Health Association, 
        and the Association of Reproductive Health Professionals, 
        support over-the-counter access to ECPs.
            (10) On April 21, 2003, product manufacturers Women's 
        Capital Corporation submitted an application to the Food and 
        Drug Administration requesting to switch the emergency 
        contraceptive Plan B from prescription-only to over-the-counter 
        (``OTC'') status.
            (11) ECPs meet all the customary FDA criteria for over-the-
        counter status in that they are safe and effective, are not 
        associated with any serious or harmful side-effects, are easily 
        self-administered, and require no need for medical supervision. 
        Moreover, ECPs are not harmful to an existing pregnancy and 
        their use does not lead to riskier behavior or less frequent 
        use of other forms of contraception, has no potential for 
        overdose or addiction, is not harmful to an existing pregnancy, 
        is easily self-administered, and requires no need for medical 
        screening.
            (12) FDA staff and experts appointed to the advisory 
        committees considered volumes of evidence showing that making 
        Plan B available over-the-counter was safe and effective for 
        women of all reproductive age.
            (13) On December 16, 2003, a joint panel of the FDA's 
        Reproductive Health Drugs Advisory Committee and Non-
        Prescription Drugs Advisory Committee voted 28-0 that Plan B 
        could be safely sold as an over-the-counter medication.
            (14) On December 16, 2003, a joint panel of the FDA's 
        Reproductive Health Drugs Advisory Committee and Non-
        prescription Drugs Advisory Committee voted 23-4 to recommend 
        that the FDA approve the application to make Plan B available 
        over-the-counter for women of all ages.
            (15) The FDA's rejection of over-the-counter status for 
        Plan B on May 6, 2004, directly contradicted the overwhelming 
        weight of scientific evidence.
            (16) The limited options offered by the FDA for future 
        consideration of over-the-counter sale of Plan B are not 
        warranted by the volumes of existing evidence and run counter 
        to the advice of the FDA's independent experts, staff, and 
        precedent.
            (17) Evidence suggests that the FDA's decision resulted 
        from an unprecedented political takeover of what is supposed to 
        be an independent scientific review.

SEC. 3. FDA DENIAL OF OTC STATUS FOR EMERGENCY-CONTRACEPTIVE DRUG PLAN 
              B; REVIEW BY COMMISSIONER OF FOOD AND DRUGS.

    (a) In General.--Not later than 30 days after the date of the 
enactment of this Act, the Commissioner of Food and Drugs shall--
            (1) review the decision of the Food and Drug Administration 
        not to approve the supplemental application submitted under 
        section 505(b) of the Federal Food, Drug, and Cosmetic Act to 
        obtain approval for the commercial distribution of the drug 
        Plan B (levonorgestrel in 0.75 mg. tablet form) as a drug that 
        is not subject to the requirements of section 503(b)(1) of such 
        Act (commonly known as an over-the-counter, or OTC, drug); and
            (2) affirm, under penalty of law, that such decision--
                    (A) was not politically influenced;
                    (B) was based on sound science; and
                    (C) conformed to precedents and procedures of the 
                Food and Drug Administration.
    (b) Publication in Federal Register.--The affirmation under 
subsection (a) shall be made through a statement published in the 
Federal Register.
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