(II) that the license holder failed 
to comply with an order issued under 
clause (i). 
(B) MAXIMUM
MONETARY
AMOUNT.—A 
monetary amount awarded under subparagraph 
(A)(iii) shall not be greater than the revenue 
that the license holder earned on the covered 
product during the period— 
(i) beginning on— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
the date that is 31 days after the date 
on which the license holder received 
the request; or 
(II) for a covered product that is 
subject to a REMS with ETASU, the 
date that is 31 days after the later 
of— 
(aa) the date on which the 
license holder received the re-
quest; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization 
issued by the Secretary in ac-
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cordance with paragraph (2)(B); 
and 
(ii) ending on the date on which the 
eligible product developer received suffi-
cient quantities of the covered product. 
(C) AVOIDANCE
OF
DELAY.—The court 
may issue an order under subparagraph (A)(i) 
before conducting further proceedings that may 
be necessary to determine whether the eligible 
product developer is entitled to an award under 
clause (ii) or (iii) of subparagraph (A), or the 
amount of any such award. 
(c) LIMITATION OF LIABILITY.—A license holder for 
a covered product shall not be liable for any claim arising 
out of the failure of an eligible product developer to follow 
adequate safeguards to assure safe use of the covered 
product during development or testing activities described 
in this section, including transportation, handling, use, or 
disposal of the covered product by the eligible product de-
veloper. 
(d) RULE OF CONSTRUCTION.— 
(1) DEFINITION.—In this subsection, the term 
‘‘antitrust laws’’— 
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(A) has the meaning given the term in 
subsection (a) of the first section of the Clayton 
Act (15 U.S.C. 12); and 
(B) includes section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the 
extent that such section applies to unfair meth-
ods of competition. 
(2) ANTITRUST LAWS.—Nothing in this section 
shall be construed to limit the operation of any pro-
vision of the antitrust laws. 
SEC. 4. REMS APPROVAL PROCESS FOR SUBSEQUENT FIL-
ERS. 
Section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1) is amended— 
(1) in subsection (g)(4)(B)— 
(A) in clause (i) by striking ‘‘or’’ after the 
semicolon; 
(B) in clause (ii) by striking the period at 
the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(iii) accommodate different approved 
risk evaluation and mitigation strategies 
for a reference drug product and a drug 
that is the subject of an abbreviated new 
drug application.’’; and 
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(2) in subsection (i)(1), by striking subpara-
graph (B) and inserting the following: 
‘‘(B) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug. 
‘‘(i) Subject to clause (ii), a drug that 
is the subject of an abbreviated new drug 
application may use— 
‘‘(I) a single, shared system with 
the listed drug under subsection (f); 
or 
‘‘(II) a different, comparable as-
pect of the elements to assure safe use 
under subsection (f). 
‘‘(ii) The Secretary may require a 
drug that is the subject of an abbreviated 
new drug application and the listed drug to 
use a single, shared system under sub-
section (f), if the Secretary determines 
that no different, comparable aspect of the 
elements to assure safe use could satisfy 
the requirements of subsection (f).’’. 
Æ 
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