[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 386 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 386

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                             orphan drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 31, 2001

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

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                             orphan drugs.

    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 ``Orphan Drug Program Improvement Act 
of 2001''.

SEC. 2. FEDERAL FOOD, DRUG, AND COSMETIC ACT; AMENDMENTS TO PROGRAM FOR 
              ORPHAN DRUGS.

    (a) Conforming Orphan-Drug Designation to Reflect Labeling of 
Approved Drug.--Section 526(a) of the Federal Food, Drug and Cosmetic 
Act (21 U.S.C. 360bb(a)) is amended--
            (1) by redesignating paragraph (2) as paragraph (3); and
            (2) by inserting after paragraph (1) the following 
        paragraph:
    ``(2) In approving an application filed pursuant to section 505 for 
a drug designated under paragraph (1), or approving the issuance of a 
license under section 351 of the Public Health Service Act for a drug 
so designated, the Secretary shall, with respect to the intended use of 
the drug, conform the designation of the drug under paragraph (1) to 
reflect the labeling that is approved for the drug.''.
    (b) Clinical Superiority of Subsequent Drug.--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 exhibit the same 
clinically superior features.
    ``(2) In paragraph (1), the term `clinically superior' means a drug 
(that is otherwise the same drug) that is shown to provide better 
safety or better efficacy, or to provide a major contribution to 
patient care.
    ``(3) In making a determination of whether a drug is clinically 
superior for purposes of this subsection, the Secretary, upon request 
of the applicant involved, shall refer a determination as to whether 
the drug provides a major contribution to patient care to an advisory 
committee.''.
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