text: 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.
target: 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.
feat_title: 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.