I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preserving Access to 

5 Orphan Drugs Act of 2018’’. 


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1 SEC. 2. CLARIFICATION OF ORPHAN DRUG EXCEPTION TO 

2 ANNUAL FEE ON BRANDED PRESCRIPTION 

3 PHARMACEUTICAL MANUFACTURERS AND 

4 IMPORTERS. 

5 (a) IN GENERAL.—Section 9008(e)(3) of the Patient 

6 Protection and Affordable Care Act is amended to read 

7 as follows: 

8 ‘‘(3) EXCLUSION OF ORPHAN DRUG SALES.— 

9 ‘‘(A) IN GENERAL.—The term ‘branded 

10 prescription drug sales’ shall not include sales 

11 of any drug or biological product— 

12 ‘‘(i) with respect to which a credit was 

13 allowed for any taxable year under section 

14 45C of the Internal Revenue Code of 1986, 

15 ‘‘(ii) with respect to which a credit 

16 was allowable for any taxable year begin17 ning before January 1, 2011, under such 

18 section 45C (without regard to whether 

19 such credit was claimed or received), or 

20 ‘‘(iii) which was any drug or biological 

21 product approved or licensed prior to Jan22 uary 1, 2011, by the Food and Drug Ad23 ministration, for marketing solely for 1 or 

24 more rare diseases or conditions. 

25 ‘‘(B) EXPIRATION.—Subparagraph (A) 

26 shall not apply with respect to any drug or bioVerDate Sep 11 2014 23:40 Dec 19, 2018 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7324.IH H7324

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1 logical product after the date on which such 

2 drug or biological product is approved or li3 censed by the Food and Drug Administration 

4 for marketing for any indication other than the 

5 treatment of a rare disease or condition. 

6 ‘‘(C) RARE DISEASE OR CONDITION.—For 

7 purposes of this paragraph, the term ‘rare dis8 ease or condition’ has the meaning given such 

9 term under section 45C(d)(1) of the Internal 

10 Revenue Code of 1986.’’. 

11 (b) HOLD HARMLESS FOR COVERED ENTITIES WITH

12 NO OR LIMITED ORPHAN DRUG SALES.—Section 9008(b) 

13 of the Patient Protection and Affordable Care Act is 

14 amended by adding at the end the following new para15 graph: 

16 ‘‘(5) ADJUSTMENT FOR CERTAIN COVERED EN17 TITIES WITH NO OR LIMITED ORPHAN DRUG

18 SALES.—If— 

19 ‘‘(A) the fee under this section for a cal20 endar year with respect to a covered entity (de21 termined without regard to this paragraph), ex22 ceeds 

23 ‘‘(B) the fee that would be determined 

24 under this section for such year with respect to 

25 such entity if branded prescription drug sales of 


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1 all covered entities were determined without re2 gard to clauses (ii) and (iii) of subsection 

3 (e)(3)(A), 

4 then such entity’s fee under this section for such cal5 endar year shall be determined as described in sub6 paragraph (B).’’. 

7 (c) EFFECTIVE DATE.—The amendments made by 

8 this section shall apply with respect to fees the annual 

9 payment date for which under section 9008 of the Patient 

10 Protection and Affordable Care Act is after December 31, 

11 2018. 

Æ 


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