I 

114TH CONGRESS 

1ST SESSION H. R. 3678 

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 

OCTOBER 1, 2015 

Mr. KELLY of Pennsylvania (for himself, Mrs. BLACK, Mr. NEAL, Mr. HOLDING, Mr. RANGEL, Ms. JENKINS of Kansas, Mr. TIBERI, Mr. MARCHANT, 

and Mr. NUNES) 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 2015’’. 


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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.—Paragraph (3) of section 9008(e) 

6 of the Patient Protection and Affordable Care Act (26 

7 U.S.C. 4001 note prec.; Public Law 111–148) is amended 

8 to read as follows: 

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

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

11 prescription drug sales’ shall not include sales 

12 of any drug or biological product— 

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

14 allowed for any taxable year under section 

15 45C of the Internal Revenue Code of 1986; 

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

17 was allowable for any taxable year begin18 ning before January 1, 2011, under such 

19 section 45C (without regard to whether 

20 such credit was claimed or received); or 

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

22 product approved or licensed prior to Jan23 uary 1, 2011, by the Food and Drug Ad24 ministration, for marketing solely for 1 or 

25 more rare diseases or conditions. 


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1 ‘‘(B) EXPIRATION.—Subparagraph (A) 

2 shall not apply with respect to any drug or bio3 logical product after the date on which such 

4 drug or biological product is approved or li5 censed by the Food and Drug Administration 

6 for marketing for any indication other than the 

7 treatment of a rare disease or condition. 

8 ‘‘(C) RARE DISEASE OR CONDITION.—In 

9 this paragraph, the term ‘rare disease or condi10 tion’ has the meaning given such term under 

11 section 45C(d)(1) of the Internal Revenue Code 

12 of 1986.’’. 

13 (b) HOLD HARMLESS FOR COVERED ENTITIES WITH

14 NO OR LIMITED ORPHAN DRUG SALES.—Subsection (b) 

15 of section 9008 of the Patient Protection and Affordable 

16 Care Act (26 U.S.C. 4001 note prec.; Public Law 111– 

17 148) is amended by adding at the end the following new 

18 paragraph: 

19 ‘‘(5) ADJUSTMENT FOR CERTAIN COVERED EN20 TITIES WITH NO OR LIMITED ORPHAN DRUG

21 SALES.—If— 

22 ‘‘(A) the fee under this section for a cal23 endar year with respect to a covered entity (de24 termined without regard to this paragraph), ex25 ceeds 


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

2 under this section for such year with respect to 

3 such entity if branded prescription drug sales of 

4 all covered entities were determined without re5 gard to clauses (ii) and (iii) of subsection 

6 (e)(3)(A), 

7 then such entity’s fee under this section for such cal8 endar year shall be determined as described in sub9 paragraph (B).’’. 

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

11 this section shall apply with respect to fees the annual 

12 payment date for which under section 9008 of the Patient 

13 Protection and Affordable Care Act (26 U.S.C. 4001 note 

14 prec.; Public Law 111–148) is after December 31, 2014. 

Æ 


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