[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3552 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 3552

            Respecting market exclusivity for certain drugs.


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                    IN THE HOUSE OF REPRESENTATIVES

                           November 19, 1993

   Mrs. Collins of Illinois introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
            Respecting market exclusivity for certain drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, That section 
505(j)(4)(D)(ii) of the Federal Food, Drug, and Cosmetic Act is amended 
by adding the following: ``If an application (other than an abbreviated 
new drug application) submitted under subsection (b) for a drug, no 
active ingredient (including an ester or salt of the active ingredient) 
of which has been approved in any other application under subsection 
(b), was filed before September 1, 1982, was under regulatory review 
(as the regulatory review period is defined in section 156(g) of title 
35, United States Code) for at least 78 months and was approved October 
29, 1992, no application may be submitted under this subsection which 
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 such application can 
be approved before the expiration of 5 years from the date of the 
approval of the subsection (b) application plus the amount by which the 
regulatory review period exceeds 84 months, except that the period of 
additional market exclusivity may not exceed 24 months.''.

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