SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN-
SURE OF ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), by striking ‘‘Except as 
provided in subsection (b)’’ and inserting ‘‘Except as 
provided in subsection (b) or (f)’’; and 
(2) by adding at the end the following: 
‘‘(f) LIMITATIONS ON EXCLUSIVE APPROVAL, CER-
TIFICATION, OR LICENSE.— 
‘‘(1) IN
GENERAL.—For a drug designated 
under section 526 for a rare disease or condition 
pursuant to the criteria set forth in subsection 
(a)(2)(B) of such section, the Secretary shall not 
grant, recognize, or apply exclusive approval or licen-
sure under subsection (a), and, if such exclusive ap-
proval or licensure has been granted, recognized, or 
applied, shall revoke such exclusive approval or licen-
sure, unless the sponsor of the application for such 
drug demonstrates— 
‘‘(A) with respect to an application ap-
proved or a license issued after the date of en-
actment of this subsection, upon such approval 
or issuance, that there is no reasonable expecta-
tion at the time of such approval or issuance 
that the cost of developing and making avail-
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able in the United States such drug for such 
disease or condition will be recovered from sales 
in the United States of such drug, taking into 
account all sales made or reasonably expected 
to be made within 12 years of first marketing 
the drug; or 
‘‘(B) with respect to an application ap-
proved or a license issued on or prior to the 
date of enactment of this subsection, not later 
than 60 days after such date of enactment, that 
there was no reasonable expectation at the time 
of such approval or issuance that the cost of de-
veloping and making available in the United 
States such drug for such disease or condition 
would be recovered from sales in the United 
States of such drug, taking into account all 
sales made or reasonably expected to be made 
within 12 years of first marketing the drug. 
‘‘(2) CONSIDERATIONS.—For purposes of sub-
paragraphs (A) and (B) of paragraph (1), the Sec-
retary and the sponsor of the application for the 
drug designated for a rare disease or condition de-
scribed in such paragraph shall consider sales from 
all drugs that— 
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‘‘(A) are developed or marketed by the 
same sponsor or manufacturer of the drug (or 
a licensor, predecessor in interest, or other re-
lated entity to the sponsor or manufacturer); 
and 
‘‘(B) are covered by the same designation 
under section 526. 
‘‘(3) CRITERIA.—No drug designated under 
section 526 for a rare disease or condition pursuant 
to the criteria set forth in subsection (a)(2)(B) of 
such section shall be eligible for exclusive approval 
or licensure under this section unless it met such 
criteria under such subsection on the date on which 
the drug was approved or licensed.’’. 
(b) RULE
OF CONSTRUCTION.—The amendments 
made in subsection (a) shall apply to any drug that has 
been or is hereafter designated under section 526 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) 
for a rare disease or condition pursuant to the criteria 
under subsection (a)(2)(B) of such section regardless of— 
(1) the date on which such drug is designated 
or becomes the subject of a designation request 
under such section; 
(2) the date on which such drug is approved 
under section 505 of such Act (21 U.S.C. 355) or 
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licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262) or becomes the subject 
of an application for such approval or licensure; and 
(3) the date on which such drug is granted ex-
clusive approval or licensure under section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360cc) or becomes the subject of a request 
for such exclusive approval or licensure. 
SEC. 3. DETERMINATION OF BUDGETARY EFFECTS. 
The budgetary effects of this Act, for the purpose of 
complying with the Statutory Pay-As-You-Go Act of 2010, 
shall be determined by reference to the latest statement 
titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 
Act, submitted for printing in the Congressional Record 
by the Chairman of the House Budget Committee, pro-
vided that such statement has been submitted prior to the 
vote on passage. 
Æ 
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