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 with-
in 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 Representa-
tives 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’’. 
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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 begin-
ning 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 Jan-
uary 1, 2011, by the Food and Drug Ad-
ministration, for marketing solely for 1 or 
more rare diseases or conditions. 
‘‘(B) 
EXPIRATION.—Subparagraph 
(A) 
shall not apply with respect to any drug or bio-
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logical product after the date on which such 
drug or biological product is approved or li-
censed 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 dis-
ease 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 para-
graph: 
‘‘(5) ADJUSTMENT FOR CERTAIN COVERED EN-
TITIES
WITH
NO
OR
LIMITED
ORPHAN
DRUG 
SALES.—If— 
‘‘(A) the fee under this section for a cal-
endar year with respect to a covered entity (de-
termined without regard to this paragraph), ex-
ceeds 
‘‘(B) the fee that would be determined 
under this section for such year with respect to 
such entity if branded prescription drug sales of 
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all covered entities were determined without re-
gard to clauses (ii) and (iii) of subsection 
(e)(3)(A), 
then such entity’s fee under this section for such cal-
endar year shall be determined as described in sub-
paragraph (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. 
Æ 
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