Plan B for Plan B Act of 2005

Plan B for Plan B Act of 2005 - Requires the Commissioner of Food and Drugs to approve or disapprove within 30 days the supplemental new drug application submitted by Women's Capital Corporation for Plan B (defined as .75 mg levonorgestrel tablets [commonly referred to as the morning-after pill]), as amended by a formal response to the Food and Drug Administration's non-approvable determination, that would switch the drug from prescription-only to nonprescription status for women 16 years or older. Deems the Commissioner as having approved the application if the deadline is not met and continues such approval unless the Commissioner publishes in the Federal Register a determination to approve or disapprove the application.

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4229 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4229

 To require the Commissioner of Food and Drugs to determine whether to 
allow the marketing of Plan B as a prescription drug for women 15 years 
of age or younger and a nonprescription drug for women 16 years of age 
                   or older, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 3, 2005

  Mrs. Maloney (for herself, Mr. Shays, Mr. Inslee, Mr. Crowley, Ms. 
 Wasserman Schultz, Mr. Bishop of New York, Mr. Farr, Mrs. Capps, Ms. 
Eshoo, Mr. Berman, Ms. Linda T. Sanchez of California, Ms. Schakowsky, 
   Mr. Waxman, Ms. Baldwin, Mr. DeFazio, Mr. Rothman, Mr. Honda, Mr. 
 Filner, Ms. Solis, Mr. Frank of Massachusetts, Mr. Moran of Virginia, 
Ms. Matsui, Mr. Grijalva, Mr. Larsen of Washington, Mr. Gutierrez, Mr. 
  Engel, Ms. McCollum of Minnesota, Mr. Kennedy of Rhode Island, Mr. 
   Hinchey, Mr. McGovern, Mr. Ackerman, Mr. Sabo, Mrs. McCarthy, Ms. 
DeLauro, Mr. Evans, Mr. Israel, Ms. Woolsey, Mr. Kucinich, and Mr. Wu) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To require the Commissioner of Food and Drugs to determine whether to 
allow the marketing of Plan B as a prescription drug for women 15 years 
of age or younger and a nonprescription drug for women 16 years of age 
                   or older, 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 ``Plan B for Plan B Act of 2005''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The Food and Drug Administration has declared Plan B to 
        be safe and effective in preventing unintended pregnancy, 
        reducing the risk by as much as 89 percent if taken within days 
        of unprotected intercourse and up to 95 percent if taken in the 
        first 24 hours.
            (2) On April 21, 2003, product manufacturers Women's 
        Capital Corporation, controlled by Barr Pharmaceuticals, 
        submitted a supplemental new drug application to the Food and 
        Drug Administration to switch Plan B from prescription-only to 
        over-the-counter status for women of all ages.
            (3) On December 16, 2003, a joint panel of the Food and 
        Drug Administration's Reproductive Health Drugs Advisory 
        Committee and Non-Prescription Drugs Advisory Committee voted 
        28-0 that Plan B could be used safely in a non-prescription 
        setting.
            (4) On December 16, 2003, a joint panel of the Food and 
        Drug Administration's Reproductive Health Drugs Advisory 
        Committee and Non-Prescription Drugs Advisory Committee voted 
        23-4 to recommend that the Food and Drug Administration approve 
        the application to make Plan B available over-the-counter for 
        women of all ages.
            (5) On May 6, 2004, the Food and Drug Administration deemed 
        the application not approvable, directly contradicting the 
        overwhelming weight of their own scientific evidence.
            (6) At the suggestion of the Food and Drug Administration, 
        Barr Pharmaceutical submitted a formal response, dated July 16, 
        2003, to the Administration's non-approvable determination, 
        supporting the marketing of Plan B as a prescription drug for 
        women 15 years of age or younger and a nonprescription drug for 
        women 16 years of age or older.
            (7) On January 21, 2005, the Food and Drug Administration 
        delayed issuing a decision on the Plan B application.
            (8) A letter dated July 13, 2005, from Secretary of Health 
        and Human Services Michael O. Leavitt to Chairman Mike Enzi of 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate stated that the Food and Drug Administration would act 
        on the Plan B application by September 1, 2005.
            (9) On August 26, 2005, the Food and Drug Administration 
        did not approve or disapprove the Plan B application, and 
        instead decided to publish an advance notice of proposed 
        rulemaking in the Federal Register, even while concluding that 
        ``the available scientific data are sufficient to support the 
        safe use of Plan B as an OTC product . . . for women who are 17 
        years of age or older''.
            (10) On August 31, 2005, Susan F. Wood, serving as the Food 
        and Drug Administration's assistant commissioner for women's 
        health and director of the Office of Women's Health, resigned 
        her position because of the Administration's refusal to issue a 
        final decision on the Plan B application, saying that she could 
        not serve at the Administration when ``scientific and clinical 
        evidence, fully evaluated and recommended for approval by the 
        professional staff [at the Administration], has been 
        overruled''.
            (11) On September 1, 2005, the Food and Drug Administration 
        issued an advance notice of proposed rulemaking (70 FR 52050) 
        to request comment by November 1, 2005, on whether to initiate 
        a rulemaking to codify the Administration's interpretation of 
        section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 353(b)) regarding when an active ingredient may be 
        simultaneously marketed in both a prescription drug product and 
        an over-the-counter (OTC) drug product, potentially adding 
        years of unnecessary regulatory delays to an already extended 
        process which is keeping Plan B from over-the-counter status.

SEC. 3. DECISION BY FDA ON MARKETING OF EMERGENCY CONTRACEPTION.

    (a) In General.--Not later than 30 days after the date of the 
enactment of this Act, the Commissioner of Food and Drugs shall approve 
or disapprove the supplemental new drug application for Plan B, as 
amended by the formal response to the non-approvable letter.
    (b) Failure to Approve or Disapprove.--If the Commissioner fails to 
approve or disapprove the application described in subsection (a) by 
the deadline described in such subsection--
            (1) the Commissioner is deemed to have approved the 
        application; and
            (2) such deemed approval shall continue in effect unless 
        the Commissioner publishes in the Federal Register a 
        determination to approve or disapprove the application.
    (c) Definitions.--In this Act:
            (1) The term ``Commissioner'' means the Commissioner of 
        Food and Drugs.
            (2) The term ``formal response'' means the formal response, 
        dated July 16, 2003, to the non-approvable letter, supporting 
        the marketing of Plan B as a prescription drug for women 15 
        years of age or younger and a nonprescription drug for women 16 
        years of age or older.
            (3) The term ``Plan B'' means 0.75 mg levonorgestrel 
        tablets.
            (4) The term ``prescription drug'' means a drug subject to 
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 353(b)(1)).
            (5) The term ``supplemental new drug application for Plan 
        B'' means the supplemental new drug application submitted under 
        section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(b)) on April 21, 2003, by product manufacturers 
        Women's Capital Corporation, controlled by Barr 
        Pharmaceuticals, to the Food and Drug Administration to switch 
        Plan B from prescription-only to nonprescription status for 
        women of all ages.
            (6) The term ``non-approvable letter'' means the non-
        approvable letter dated May 6, 2004, from the Food and Drug 
        Administration to Barr Pharmaceuticals.
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