[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3618 Introduced in House (IH)]

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114th CONGRESS
  1st Session
                                H. R. 3618

 To clarify the exclusion of orphan drug sales from the calculation of 
the annual fee on branded prescription pharmaceutical manufacturers and 
                   importers, and for other purposes.


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                    IN THE HOUSE OF REPRESENTATIVES

                           September 25, 2015

     Mr. Lance (for himself, Mr. Pascrell, Ms. Linda T. Sanchez of 
California, Mr. Tiberi, and Mr. Holding) introduced the following bill; 
which was referred to the Committee on Ways and Means, and in addition 
      to the Committee on Energy and Commerce, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

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                                 A BILL


 
 To clarify the exclusion of orphan drug sales from the calculation of 
the annual fee on branded prescription pharmaceutical manufacturers and 
                   importers, and for other purposes.

    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 Fairness Act''.

SEC. 2. EXCLUSION OF ORPHAN DRUG SALES.

    (a) In General.--Paragraph (3) of section 9008(e) of the Patient 
Protection and Affordable Care Act (26 U.S.C. 4001 note prec.; Public 
Law 111-148) is amended to read as follows:
            ``(3) Exclusion of orphan drug sales.--The term `branded 
        prescription drug sales' shall not include sales of any drug or 
        biological product with respect to which a credit was allowable 
        for any taxable year under section 45C of the Internal Revenue 
        Code of 1986, regardless of whether such credit was claimed and 
        received. The preceding sentence shall not apply with respect 
        to any such drug or biological product after the date on which 
        such drug or biological product is approved by the Food and 
        Drug Administration for marketing for any indication other than 
        the treatment of the rare disease or condition with respect to 
        which such credit was allowable.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect as if included in section 9008 of the Patient Protection 
and Affordable Care Act (26 U.S.C. 4001 note prec.; Public Law 111-
148).
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