[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4384 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 4384

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 HOUSE OF REPRESENTATIVES

                             April 18, 2012

  Mr. Van Hollen (for himself and Mr. Braley of Iowa) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 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 Drug Labeling 
Improvement Act''.

SEC. 2. PERMITTING LABELING CHANGES FOR GENERICS.

    Section 505(j) of the Federal Food, Drug, and Cosmetics 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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