Title: Preserving Access to Orphan Drugs Act of 2018
Policy area: Health

Summary:
Preserving Access to Orphan Drugs Act of 2018
This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.)

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7324 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 7324

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 17, 2018

  Mr. Kelly of Pennsylvania 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

_______________________________________________________________________

                                 A BILL


 
   To clarify the orphan drug exception to 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 ``Preserving Access to Orphan Drugs 
Act of 2018''.

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

    (a) In General.--Section 9008(e)(3) of the Patient Protection and 
Affordable Care Act 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,
                            ``(ii) with respect to which a credit was 
                        allowable for any taxable year beginning before 
                        January 1, 2011, under such section 45C 
                        (without regard to whether such credit was 
                        claimed or received), or
                            ``(iii) which was any drug or biological 
                        product approved or licensed prior to January 
                        1, 2011, by the Food and Drug Administration, 
                        for marketing solely for 1 or more rare 
                        diseases or conditions.
                    ``(B) Expiration.--Subparagraph (A) shall not apply 
                with respect to any drug or biological product after 
                the date on which such 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.--For purposes of 
                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.''.
    (b) Hold Harmless for Covered Entities With No or Limited Orphan 
Drug Sales.--Section 9008(b) of the Patient Protection and Affordable 
Care Act is amended by adding at the end the following new paragraph:
            ``(5) Adjustment for certain covered entities with no or 
        limited orphan drug sales.--If--
                    ``(A) the fee under this section for a calendar 
                year with respect to a covered entity (determined 
                without regard to this paragraph), exceeds
                    ``(B) the fee that would be determined under this 
                section for such year with respect to such entity if 
                branded prescription drug sales of all covered entities 
                were determined without regard to clauses (ii) and 
                (iii) of subsection (e)(3)(A),
        then such entity's fee under this section for such calendar 
        year shall be determined as described in subparagraph (B).''.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to fees the annual payment date for which under 
section 9008 of the Patient Protection and Affordable Care Act is after 
December 31, 2018.
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