I 
113TH CONGRESS 
1ST SESSION H. R. 2315 
To clarify the orphan drug exception to the annual fee on branded prescription 
pharmaceutical manufacturers and importers. 
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 provi-
sions 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. 
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 2013’’. 
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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 dis-
eases or conditions. 
‘‘(B) 
LIMITATION.—Subparagraph 
(A) 
shall not apply with respect to any drug or bio-
logical product after the date on which the drug 
or biological product is approved or licensed by 
the Food and Drug Administration for mar-
keting for any indication other than the treat-
ment of a rare disease or condition. 
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‘‘(C) RARE
DISEASE
OR
CONDITION.—In 
this paragraph, the term ‘rare disease or condi-
tion’ 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 cir-
cumstances as of the date such drug or biologi-
cal 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). 
Æ 
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