‘‘(5) confirmatory clinical trials are difficult or 
costly to conduct; and 
‘‘(6) such drug is intended to treat a disease or 
condition for which no more than 2 meaningful 
treatments currently exist. 
‘‘(b) APPROVAL REQUIREMENTS.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date on which the Secretary receives a re-
quest for conditional approval under subsection (a) 
with respect to a new drug, the Secretary shall re-
quire the sponsor of such drug to— 
‘‘(A) complete in a timely manner clinical 
investigations to provide full demonstration of 
safety and effectiveness as described under sec-
tion 505 of the Federal Food, Drug, and Cos-
metic Act or section 351 of the Public Health 
Service Act, as applicable; 
‘‘(B) conduct clinical trials other than con-
firmatory trials, to demonstrate a certain de-
gree of safety and efficacy of the drug; and 
‘‘(C) demonstrate that necessary post-mar-
ket surveillance and risk-management tools are 
in place with respect to the drug. 
‘‘(2) PERIOD
OF
CONDITIONAL
APPROVAL.— 
The period of conditional approval for a drug under 
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this section is effective for a 1-year period and is 
thereafter renewable by the Secretary annually for 
up to 4 additional 1-year terms. A conditional ap-
proval shall be in effect for no more than 5 years 
from the date of approval under this section. 
‘‘(3) TIME
LIMITATION.—If any conditionally 
drug approved under this section is not brought to 
market within 3 years of the conditional approval, 
any conditional approval granted under this section 
with respect to such drug shall be deemed invalid. 
‘‘(4) REQUIREMENTS.—As a condition on re-
ceipt of conditional approval under this section, the 
Secretary shall require the sponsor of the drug to 
agree to the following: 
‘‘(A) Complete in a timely manner such 
clinical investigations to provide a full dem-
onstration of effectiveness as the Secretary de-
termines to be necessary for approval of the 
drug under section 505 of this Act or section 
351 of the Public Health Service Act, as appli-
cable. 
‘‘(B) Submit to the Secretary an annual 
report on the progress of the sponsor in con-
ducting the clinical investigations required 
under this section. 
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‘‘(C) Ensure that all labeling and pro-
motional materials for the drug bear the state-
ment ‘conditionally approved by the FDA pend-
ing a full demonstration of effectiveness under 
applicable lll’ (specifying the application 
number assigned by the Secretary in place of 
the blank). 
‘‘(5) APPLYING
FOR
FULL
APPROVAL.—The 
sponsor of a drug granted conditional approval pur-
suant to this section may, at any point, submit an 
application for full approval as described under sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act or section 351 of the Public Health Service Act, 
as applicable. 
‘‘(6) UTILIZATION OF REAL WORLD EVIDENCE 
TO SUPPORT FULL APPROVAL.—The Secretary shall 
allow the use of real world evidence, as defined in 
section 505F(b), and collected by the sponsor of a 
drug during the duration of conditional approval 
granted approval to this subsection, to supplement 
an application for full approval, in addition to other 
post-approval studies. 
‘‘(c) LIMITATION ON LIABILITY.— 
‘‘(1) IN GENERAL.—With respect to any claim 
under State law alleging that a drug sold or other-
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wise made available pursuant to a grant of condi-
tional approval under this section is unsafe or inef-
fective, no liability in a cause of action shall lie 
against a sponsor or manufacturer, unless the rel-
evant conduct constitutes reckless or willful mis-
conduct, gross negligence, or an intention tort under 
any applicable State law. 
‘‘(2) RULE OF CONSTRUCTION.—Except as set 
forth in subparagraph (A), nothing in this sub-
section shall be construed to modify or otherwise af-
fect the right of any person to bring private action 
under any Federal or State product liability, tort, 
consumer protection, or warranty law. 
‘‘(d) DEFINITIONS.—In this Act: 
‘‘(1) SERIOUSLY
DEBILITATING
DISEASES.— 
The term ‘severely debilitating diseases’ means dis-
eases or conditions that cause major irreversible 
morbidity. 
‘‘(2) LIFE-THREATENING DISEASES.—The term 
‘life-threatening diseases’ means— 
‘‘(A) a disease or condition where the like-
lihood of death is high unless the course of the 
disease is interrupted; or 
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‘‘(B) a disease or condition with potentially 
fatal outcomes, where the end point of clinical 
trial analysis is survival. 
‘‘(3) CHRONIC CONDITION.—The term ‘chronic 
condition’ means a disease or condition that— 
‘‘(A) usually lasts for 3 months or longer; 
and 
‘‘(B)(i) requires ongoing medical attention; 
or 
‘‘(ii) limits activities of daily living.’’. 
(b) REGULATIONS AND GUIDANCE.—Not later than 
1 year after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall issue final 
regulations and guidance for carrying out section 524B 
of the Federal Food, Drug, and Cosmetic Act. 
(c) CONFORMING AMENDMENT.—Section 505(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(a)) is amended by inserting ‘‘, or there is in effect 
a conditional approval under section 524B with respect 
to such drug’’ before the period. 
Æ 
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