[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 2295 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 2295

To permit manufacturers of generic drugs to provide additional warnings 
 with respect to such drugs in the same manner that the Food and Drug 
              Administration allows brand names to do so.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 18, 2012

  Mr. Leahy (for himself, Mr. Franken, Mr. Coons, Mr. Whitehouse, Mr. 
    Bingaman, Mr. Brown of Ohio, and Mr. Blumenthal) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To permit manufacturers of generic drugs to provide additional warnings 
 with respect to such drugs in the same manner that the Food and Drug 
              Administration allows brand names to do so.

    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 ``Patient Safety and Generic Labeling 
Improvement Act''.

SEC. 2. WARNING LABELING WITH RESPECT TO GENERIC DRUGS.

    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:
            ``(11)(A) Notwithstanding any other provision of this Act, 
        the holder of an approved application under this subsection may 
        change the labeling of a drug so approved in the same manner 
        authorized by regulation for the holder of an approved new drug 
        application under subsection (b).
            ``(B) In the event of a labeling change made under 
        subparagraph (A), the Secretary may order conforming changes to 
        the labeling of the equivalent listed drug and each drug 
        approved under this subsection that corresponds to such listed 
        drug.''.
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