[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1778 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1778

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                 generic drugs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 14, 2009

  Mrs. Shaheen (for herself and Mr. Vitter) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                 generic drugs, 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 ``Access to Affordable Medicines 
Act''.

SEC. 2. LABELING CHANGES.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is amended by adding at the end the following:
    ``(10) If the proposed labeling of a drug that is the subject of an 
application under this subsection is different from the labeling of the 
listed drug at the time the Secretary evaluates the application under 
this subsection, the drug that is the subject of such application 
shall, notwithstanding any other provision of this Act, be eligible for 
approval and shall not be considered misbranded under section 502 if--
            ``(A) a revision to the labeling of the listed drug has 
        been approved by the Secretary within 60 days of the expiration 
        of the patent or exclusivity period that otherwise prohibited 
        the approval of the drug under this subsection;
            ``(B) the Secretary has not determined the applicable text 
        of the labeling for the drug that is the subject the 
        application under this subsection at the time of expiration of 
        such patent or exclusivity period;
            ``(C) the labeling revision described under subparagraph 
        (A) does not include a change to the `Warnings' section of the 
        labeling;
            ``(D) the Secretary does not deem that the continued 
        presence in commerce of the labeling of the listed drug (as in 
        effect before the revision described under subparagraph (A)) 
        adversely impacts the safe use of the drug;
            ``(E) the sponsor of the application under this subsection 
        agrees to submit revised labeling of the drug that is the 
        subject of such application not later than 60 days after the 
        notification of any changes to such labeling required by the 
        Secretary; and
            ``(F) such application otherwise meets the applicable 
        requirements for approval under this subsection.''.
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