[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1734 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                S. 1734

    To amend the Federal Food, Drug, and Cosmetic Act to expand the 
               provisions relating to market exclusivity.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

            November 20 (legislative day, November 2), 1993

 Mr. Simon (for himself, Mr. Hatch, and Ms. Moseley-Braun) introduced 
the following bill; which was read twice and referred to the Committee 
                            on the Judiciary

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to expand the 
               provisions relating to market exclusivity.

    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 ``Market Exclusivity Act of 1993''.

SEC. 2. MARKET EXCLUSIVITY.

    Section 505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(4)(D)) is amended by adding at the end the following 
new clause:
    ``(vi) If--
            ``(I) an application (other than an abbreviated new drug 
        application) was submitted under subsection (b) for a drug;
            ``(II) no active ingredient of the drug (including an ester 
        or salt of the active ingredient) has been approved in any 
        other application under subsection (b);
            ``(III) the application was filed before September 1, 1982;
            ``(IV) the application was under regulatory review for a 
        regulatory review period (as defined in section 156(g) of title 
        35, United States Code) for at least 78 months; and
            ``(V) the application was approved October 29, 1992,
no application may be submitted under this subsection that refers to 
the drug for which the subsection (b) application was submitted before 
the expiration of 5 years from the date of the approval of the 
subsection (b) application, and no application submitted under this 
subsection that refers to such drug may be approved before the 
expiration of 5 years from the date of approval of the subsection (b) 
application plus the amount by which the regulatory review period 
exceeds 84 months, except that the period for such amount of additional 
market exclusivity shall not exceed 24 months.''.

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