‘‘(i) The requirements under para-
graph (3), including requirements related 
to— 
‘‘(I) informed consent; and 
‘‘(II) continued pursuit of safety 
and efficacy data for purposes of 
gaining approval for such drug under 
section 505 of this Act or section 351 
of the Public Health Service Act. 
‘‘(ii) The rules under paragraphs (4) 
and (5) relating to the length of the termi-
nation of the provisional approval and 
withdrawal of a drug subject to provisional 
approval. 
‘‘(C) REQUEST
FOR
PROVISIONAL
AP-
PROVAL.— 
‘‘(i) IN GENERAL.—The sponsor of a 
drug that is designated as a fast track 
product under this section may request 
that the Secretary grant provisional ap-
proval for such drug under subparagraph 
(A). 
‘‘(ii) RESPONSE
TO
REQUEST.—Not 
later than 90 days after receiving such a 
request, the Secretary shall either— 
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‘‘(I) grant provisional approval 
for the drug under subparagraph (A); 
or 
‘‘(II) provide notice to the spon-
sor of the drug that such request is 
denied. 
‘‘(2) ADEQUATELY SAFE DEFINED.— 
‘‘(A) IN GENERAL.—For purposes of this 
subsection, with respect to a drug, the term 
‘adequately safe’ means that— 
‘‘(i) for at least one population, the 
risk of death or morbidity caused directly 
by an adverse effect of the drug, as deter-
mined in one or more safety studies or 
through other data that the Secretary de-
termines are sufficient, is unlikely to be 
greater than the combined direct and sec-
ondary risks of death or morbidity, as es-
tablished in the literature or historical 
data, of— 
‘‘(I) the disease that such drug is 
intended to treat; and 
‘‘(II) existing therapies (includ-
ing infection) for such disease; or 
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‘‘(ii) the drug has had a valid mar-
keting authorization, for a period of at 
least 4 years, by an authority in a country 
described in section 802(b)(1)(A), or des-
ignated by the Secretary under section 
802(b)(1)(B), and data adequate for the 
approval of such marketing authorization 
for such drug in such country have been 
submitted to the Secretary. 
‘‘(B) LIMITATION.—The Secretary may 
not impose any requirements for purposes of 
the safety studies or data under subparagraph 
(A)(i) that are in addition to, or different than, 
the requirements for studies to establish safety 
for purposes of Phase 1 or Phase 2, as such 
terms are described in subsections (a) and (b), 
respectively, of section 312.21 of title 21, Code 
of Federal Regulations. 
‘‘(3) REQUIREMENTS.—Provisional approval of 
a fast track product under this subsection shall be 
subject to the following requirements: 
‘‘(A) INFORMED CONSENT.— 
‘‘(i) IN GENERAL.—As a condition of 
provisional approval under paragraph (1), 
the sponsor of a drug shall ensure that, be-
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fore such drug is dispensed to an indi-
vidual— 
‘‘(I) the individual shall be in-
formed that the drug is subject to 
provisional approval based on limited 
safety data and that the efficacy of 
the drug has not been proven; 
‘‘(II) the individual shall be in-
formed of the known risks of the drug 
and any unknown but reasonably pre-
dictable risks of the drug, including, 
as appropriate, potential risks of 
death, complications, or injury result-
ing from use of the drug, and risks 
related to the potential ineffectiveness 
of the drug, including progression of 
the disease that may result in death 
or morbidity, or the potential for the 
drug to accelerate or exacerbate the 
disease process; and 
‘‘(III) the individual provides 
written informed consent acknowl-
edging that individual has been pro-
vided with and understands the infor-
mation under subclauses (I) or (II). 
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‘‘(ii) REGULATIONS.—The Secretary 
shall issue regulations on the requirements 
for informed consent under clause (i). 
Such regulations shall be similar to the re-
quirements 
for 
informed 
consent 
for 
human subjects under subpart B of part 
50 of title 21, Code of Federal Regula-
tions, adjusted as appropriate for purposes 
of this subsection. 
‘‘(B) PURSUIT
OF
FULL
APPROVAL
RE-
QUIRED.—A sponsor of a drug that receives a 
provisional approval under paragraph (1) shall 
continue to diligently conduct appropriate stud-
ies, after such provisional approval is granted, 
to— 
‘‘(i) establish that the drug has an ef-
fect on a clinical endpoint or on a surro-
gate endpoint that is reasonably likely to 
predict clinical benefit; and 
‘‘(ii) collect the data necessary to 
demonstrate that the drug is safe and ef-
fective (or, in the case of a biologic, safe 
and potent) for purpose of obtaining ap-
proval for such drug under section 505(c) 
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of this Act or section 351 of the Public 
Health Service Act. 
‘‘(C) PROMOTIONAL
MATERIALS.—During 
the period that provisional approval under para-
graph (1) applies to a drug, the sponsor of the 
drug shall submit copies of all promotional ma-
terials related to the drug at least 30 days prior 
to dissemination of the materials. 
‘‘(D) RISK EVALUATION AND MITIGATION 
STRATEGY.— 
‘‘(i) IN
GENERAL.—Section 505–1 
shall apply to a drug subject to provisional 
approval under this subsection in the same 
manner that such section applies to a drug 
approved under section 505 of this Act or 
section 351 of the Public Health Service 
Act. 
‘‘(ii) 
RULE
OF
CONSTRUCTION.— 
Nothing in this subparagraph shall be con-
strued to limit the Secretary’s authority 
under section 505–1 to determine if a risk 
evaluation and mitigation strategy is nec-
essary. 
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‘‘(E) INDICATION
OF
USE.—The provi-
sional approval under paragraph (1) shall only 
apply to the indication of use for the drug— 
‘‘(i) which is related to the treatment 
of the condition with respect to which such 
drug was designated as a fast track prod-
uct; and 
‘‘(ii) for which the drug is dem-
onstrated to be adequately safe. 
‘‘(4) 
TERMINATION
OF
PROVISIONAL
AP-
PROVAL.— 
‘‘(A) IN GENERAL.—In the case of a drug 
that is not designated under section 526, the 
provisional approval of the drug under para-
graph (1) shall terminate on the earlier of the 
following: 
‘‘(i) The date that the drug is ap-
proved under section 505(c) of this Act or 
section 351 of the Public Health Service 
Act. 
‘‘(ii) At the end of the 5-year period 
beginning on the date on which provisional 
approval was granted for such drug, ex-
cept— 
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‘‘(I) if the Secretary determines 
that the sponsor of the drug is dili-
gently engaging in actions (including 
conducting clinical trials) for the pur-
pose of seeking approval under section 
505(c) of this Act or section 351 of 
the Public Health Service Act (exclud-
ing provisional approval under para-
graph (1)) and the Secretary deter-
mines that the sponsor requires addi-
tional time to complete such actions 
and attain such approval, the Sec-
retary may extend such period for an 
appropriate length of time to allow 
the sponsor to complete such actions 
and attain such approval; or 
‘‘(II) if the Secretary determines 
that the termination of the provisional 
approval is adverse to protecting or 
promoting the public health, the Sec-
retary may extend such period for an 
appropriate length of time to protect 
or promote the public health. 
‘‘(B) 
SPECIAL
RULE
FOR
ORPHAN 
DRUGS.—In the case of a drug designated 
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under section 526, the provisional approval of 
the drug under paragraph (1) shall terminate 
on the date that the drug is approved under 
section 505(c) of this Act or section 351 of the 
Public Health Service Act. 
‘‘(C) RULE OF CONSTRUCTION.—For pur-
poses of this paragraph, the phrase ‘approved 
under section 505(c) of this Act or section 351 
of the Public Health Service Act’ shall not be 
construed to include a provisional approval 
under paragraph (1). 
‘‘(5) WITHDRAWAL.— 
‘‘(A) IN
GENERAL.—Subsection (b)(3) 
shall apply to a drug subject to a provisional 
approval under this subsection in the same 
manner as such subsection applies to any fast 
track product. 
‘‘(B) ADDITIONAL WITHDRAWAL AUTHOR-
ITY.—In addition to subparagraph (A), the Sec-
retary may withdraw approval of a fast track 
product using the expedited procedures applied 
under subsection (b)(3) if the requirements of 
paragraph (3)(A) have not been met with re-
spect to the drug. 
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‘‘(6) IMPACT ON MARKETING EXCLUSIVITY.— 
The rules related to marketing exclusivity under sec-
tions 505(c)(3)(E), 505(j)(5)(F), 505A, and 527 
shall apply to a drug subject to provisional approval 
under this subsection in the same manner that such 
rules apply to drugs approved under section 505 of 
this Act or section 351 of the Public Health Service 
Act, except that the period of provisional approval 
under this subsection for a drug shall be an addition 
to the applicable period of marketing exclusivity for 
such drug.’’. 
(b) MISBRANDING FOR MARKETING OF TERMINATED 
DRUG.—Section 502 of the Federal Food, Drug, and Cos-
metic Act is amended by adding at the end the following: 
‘‘(bb) If it is a drug that is introduced or delivered 
for introduction into interstate commerce after the date 
of the termination of the provisional approval for such 
drug under section 506(f), unless, on or before the date 
such drug is so introduced or delivered, such drug is ap-
proved under section 505(c) of this Act or section 351 of 
the Public Health Service Act.’’. 
(c) CONFORMING AMENDMENTS.—The chapter V of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351) is further amended— 
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(1) in section 502(a), by inserting ‘‘(or an indi-
cation subject to a provisional approval under sec-
tion 506(f))’’ after ‘‘an indication approved under 
section 505 or under section 351(a) of the Public 
Health Service Act’’; 
(2) in section 506A— 
(A) in subsection (a), by inserting ‘‘(or a 
provisional approval under section 506(f))’’ 
after ‘‘a license under section 351 of the Public 
Health Service Act’’; and 
(B) by adding at the end the following: 
‘‘(e) SPECIAL RULE FOR DRUGS SUBJECT TO PROVI-
SIONAL APPROVAL.—In the case of a drug subject to a 
provisional approval under section 506(f), any reference 
to safety and efficacy under this section shall be treated 
as a reference to adequate safety, as such term is defined 
for purposes of such section 506(f).’’; 
(3) in section 506B(a), by adding at the end 
the following: 
‘‘(3) SPECIAL
RULE
FOR
PROVISIONAL
AP-
PROVAL.—A sponsor of a drug that is subject to a 
provisional approval under section 506(f) shall sub-
mit the reports required under this section on the 
studies conducted on such drug that are described in 
section 506(f)(3)(B). For purposes of this section, 
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such reports shall be treated as reports on post-
marketing studies described in paragraph (1).’’; and 
(4) in section 551(b)(1)(A) by inserting ‘‘(or a 
provisional approval under section 506(f))’’ after 
‘‘Public Health Service Act’’. 
Æ 
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