[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2315 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 2315

   To clarify the orphan drug exception to the annual fee on branded 
        prescription pharmaceutical manufacturers and importers.


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                    IN THE HOUSE OF REPRESENTATIVES

                             June 11, 2013

 Mr. Gerlach (for himself and Mr. Neal) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, 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 orphan drug exception to the annual fee on branded 
        prescription pharmaceutical manufacturers and importers.

    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 ``Preserving Access to Orphan Drugs 
Act of 2013''.

SEC. 2. CLARIFICATION OF ORPHAN DRUG EXCEPTION TO ANNUAL FEE ON BRANDED 
              PRESCRIPTION PHARMACEUTICAL MANUFACTURERS AND IMPORTERS.

    (a) In General.--Paragraph (3) of section 9008(e) of the Patient 
Protection and Affordable Care Act (Public Law 111-148) is amended to 
read as follows:
            ``(3) Exclusion of orphan drug sales.--
                    ``(A) In general.--The term `branded prescription 
                drug sales' shall not include sales of any drug or 
                biological product--
                            ``(i) with respect to which a credit was 
                        allowed for any taxable year under section 45C 
                        of the Internal Revenue Code of 1986; or
                            ``(ii) which is approved or licensed by the 
                        Food and Drug Administration for marketing 
                        solely for one or more rare diseases or 
                        conditions.
                    ``(B) Limitation.--Subparagraph (A) shall not apply 
                with respect to any drug or biological product after 
                the date on which the drug or biological product is 
                approved or licensed by the Food and Drug 
                Administration for marketing for any indication other 
                than the treatment of a rare disease or condition.
                    ``(C) Rare disease or condition.--In this 
                paragraph, the term `rare disease or condition' has the 
                meaning given such term under section 45C(d)(1) of the 
                Internal Revenue Code of 1986, except that in the case 
                of any drug or biological product that has not been 
                designated under section 526 of the Federal Food, Drug, 
                and Cosmetic Act for a particular indication, 
                determinations under such section 45C(d)(1) shall be 
                made on the basis of the facts and circumstances as of 
                the date such drug or biological product is approved or 
                licensed by the Food and Drug Administration for 
                marketing for the treatment of such disease or 
                condition.''.
    (b) Effective Date.--The amendment made by this section shall take 
effect as if included in section 9008 of the Patient Protection and 
Affordable Care Act (Public Law 111-148).
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