[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4242 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 4242

 To amend section 527 of the Federal Food, Drug and Cosmetic Act with 
respect to clinically superior modifications to previously approved or 
                            licensed drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 11, 2000

Mr. Thornberry introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend section 527 of the Federal Food, Drug and Cosmetic Act with 
respect to clinically superior modifications to previously approved or 
                            licensed drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; PURPOSE.

    (a) Short Title.--This Act may be cited as the ``Orphan Drug 
Innovation Act''.
    (b) Purpose.--The purpose of the amendments made by this Act is to 
increase patient choice and ensure appropriate market protections under 
the orphan drug provisions of the Federal Food, Drug, and Cosmetic Act.

SEC. 2. AMENDMENT TO THE FEDERAL FOOD, DRUG AND COSMETIC ACT.

    Section 527 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
360cc) is amended--
            (1) in subsection (a) by striking ``subsection (b)'' and 
        inserting ``subsections (b) and (c)''; and
            (2) by adding at the end the following:
    ``(c)(1) In a case in which the Secretary approves an application 
filed pursuant to section 505, or issues a license under section 351 of 
the Public Health Service Act for a drug designated under section 526 
for a rare disease or condition, and such drug is approved or licensed 
because it is considered to be clinically superior to a previously 
approved or licensed drug designated under section 526, the seven-year 
period of prohibition against approval described in subsection (a) 
shall apply only to prohibit approval of drugs that claim the same 
clinical superiority.
    ``(2) In paragraph (1), the term `clinically superior' means a drug 
(that is otherwise the same drug) that is shown to provide a 
significant therapeutic advantage over and above that provided by an 
approved orphan drug.
    ``(3) Paragraph (1) shall apply to any drug designated on or after 
January 1, 1990.''.
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