[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 58 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                 H. R. 58

  To amend section 804 of the Federal Food, Drug, and Cosmetic Act to 
 correct impediments in the implementation of the Medicine Equity and 
                        Drug Safety Act of 2000.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 3, 2001

 Mr. Deutsch introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend section 804 of the Federal Food, Drug, and Cosmetic Act to 
 correct impediments in the implementation of the Medicine Equity and 
                        Drug Safety Act of 2000.

    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 ``Medicine Equity and Drug Safety Act 
Corrections of 2001''.

SEC. 2. CORRECTION OF IMPEDIMENTS IN IMPLEMENTATION OF MEDICINE EQUITY 
              AND DRUG SAFETY ACT OF 2000.

    (a) Access to Labeling to Permit Importation.--Section 804 of the 
Federal Food, Drug, and Cosmetic Act (as added by section 745(c)(2) of 
Public Law 106-387) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (2), by striking ``and'' at the 
                end ;
                    (B) in paragraph (3), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following paragraph:
            ``(4) specify a fair and reasonable fee that a manufacturer 
        may charge an importer for the use of labeling of a covered 
        product.'';
            (2) in subsection (e)(2), by inserting after ``used only 
        for purposes of testing'' the following: ``or the labeling of 
        covered products''; and
            (3) in subsection (h), by adding at the end the following 
        sentence: ``No manufacturer of a covered product may impose any 
        condition for the privilege of an importer using labeling for a 
        covered product, except a requirement that the importer pay a 
        fee for such use established by regulation under subsection 
        (a)(4).''.
    (b) Preventing Discrimination Against Importers.--Section 804(h) of 
such Act is amended by inserting before the period at the end of the 
first sentence the following: ``or that discriminates against a person 
on the basis of the person's importation of covered products imported 
pursuant to subsection (a) or the sale or distribution of such covered 
products''.
    (c) Conditions for Taking Effect.--Section 804(l) of such Act is 
amended in the matter preceding paragraph (1) by striking ``This 
section shall become effective'' and all that follows through ``will'' 
and inserting the following: ``This section shall become effective only 
if the Secretary certifies to the Congress that, in the determination 
of the Secretary, there is a reasonable probability that the 
implementation of this section will''.
    (d) Elimination of Sunset.--Section 804 of such Act is amended by 
striking subsection (m).
    (e) Authorization of Appropriations.--Section 804 of such Act, as 
amended by subsection (d) of this section, is amended by inserting 
after subsection (l) the following subsection:
    ``(m) Authorization of Appropriations.--There are authorized to be 
appropriated for fiscal year 2002 and each subsequent fiscal year such 
sums as may be necessary to carry out this section.''.
                                 <all>