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‘‘(vi) EXTENSIONS.—The Director of 
NIH may provide an extension of the 
deadline for submission of clinical trial in-
formation under clause (i) if the respon-
sible party for the trial submits to the Di-
rector a written request that demonstrates 
good cause for the extension and provides 
an estimate of the date on which the infor-
mation will be submitted. The Director of 
NIH may grant more than one such exten-
sion for a clinical trial. 
‘‘(F) NOTICE TO DIRECTOR OF NIH.—The 
Commissioner of Food and Drugs shall notify 
the Director of NIH when there is an action de-
scribed in subparagraph (E)(iv) or item (aa), 
(bb), or (cc) of subparagraph (E)(v)(I) with re-
spect to an application or a report that includes 
a certification required under paragraph (5)(B) 
of such action not later than 30 days after such 
action. 
‘‘(G) POSTING OF DATA.—The Director of 
NIH shall ensure that the clinical trial informa-
tion described in subparagraphs (C) and (D) 
for an applicable clinical trial submitted in ac-
cordance with this paragraph is posted publicly 
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in the registry and results database not later 
than 30 days after such submission. 
‘‘(H) WAIVERS REGARDING CERTAIN CLIN-
ICAL
TRIAL
RESULTS.—The Secretary may 
waive any applicable requirements of this para-
graph for an applicable clinical trial, upon a 
written request from the responsible party, if 
the Secretary determines that extraordinary cir-
cumstances justify the waiver and that pro-
viding the waiver is consistent with the protec-
tion of public health, or in the interest of na-
tional security. Not later than 30 days after 
any part of a waiver is granted, the Secretary 
shall notify, in writing, the appropriate commit-
tees of Congress of the waiver and provide an 
explanation for why the waiver was granted. 
‘‘(I) ADVERSE EVENTS.— 
‘‘(i) REGULATIONS.—Not later than 
18 months after the date of the enactment 
of the Food and Drug Administration 
Amendments Act of 2007, the Secretary 
shall by regulation determine the best 
method for including in the registry and 
results data bank appropriate results infor-
mation on serious adverse and frequent ad-
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verse events for drugs described in sub-
paragraph (C) in a manner and form that 
is useful and not misleading to patients, 
physicians, and scientists. 
‘‘(ii) DEFAULT.—If the Secretary fails 
to issue the regulation required by clause 
(i) by the date that is 24 months after the 
date of the enactment of the Food and 
Drug Administration Amendments Act of 
2007, clause (iii) shall take effect. 
‘‘(iii) ADDITIONAL ELEMENTS.—Upon 
the application of clause (ii), the Secretary 
shall include in the registry and results 
data bank for drugs described in subpara-
graph (C), in addition to the clinical trial 
information described in subparagraph (C), 
the following elements: 
‘‘(I) 
SERIOUS
ADVERSE 
EVENTS.—A table of anticipated and 
unanticipated serious adverse events 
grouped by organ system, with num-
ber and frequency of such event in 
each arm of the clinical trial. 
‘‘(II) 
FREQUENT
ADVERSE 
EVENTS.—A table of anticipated and 
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unanticipated adverse events that are 
not included in the table described in 
subclause (I) that exceed a frequency 
of 5 percent within any arm of the 
clinical trial, grouped by organ sys-
tem, with number and frequency of 
such event in each arm of the clinical 
trial. 
‘‘(iv) POSTING OF OTHER INFORMA-
TION.—In carrying out clause (iii), the 
Secretary shall, in consultation with ex-
perts in risk communication, post with the 
tables information to enhance patient un-
derstanding and to ensure such tables do 
not mislead patients or the lay public. 
‘‘(v) RELATION
TO
SUBPARAGRAPH 
(C).—Clinical trial information included in 
the registry and results data bank pursu-
ant to this subparagraph is deemed to be 
clinical trial information included in such 
data bank pursuant to subparagraph (C). 
‘‘(4) ADDITIONAL
SUBMISSIONS
OF
CLINICAL 
TRIAL INFORMATION.— 
‘‘(A) VOLUNTARY
SUBMISSIONS.—A re-
sponsible party for a clinical trial that is not an 
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applicable clinical trial, or that is an applicable 
clinical trial that is not subject to paragraph 
(2)(C), may submit complete clinical trial infor-
mation described in paragraph (2) or paragraph 
(3) provided the responsible party submits clin-
ical trial information for each applicable clinical 
trial that is required to be submitted under sec-
tion 351 or under section 505, 510(k), 515, or 
520(m) of the Federal Food, Drug, and Cos-
metic Act in an application or report for licen-
sure, approval, or clearance of the drug or de-
vice for the use studied in the clinical trial. 
‘‘(B) REQUIRED SUBMISSIONS.— 
‘‘(i) IN
GENERAL.—Notwithstanding 
paragraphs (2) and (3) and subparagraph 
(A), in any case in which the Secretary de-
termines for a specific clinical trial de-
scribed in clause (ii) that posting in the 
registry and results data bank of clinical 
trial information for such clinical trial is 
necessary to protect the public health— 
‘‘(I) the Secretary may require 
by notification that such information 
be submitted to the Secretary in ac-
cordance with paragraphs (2) and (3) 
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except with regard to timing of sub-
mission; 
‘‘(II) unless the responsible party 
submits a certification under para-
graph (3)(E)(iii), such information 
shall be submitted not later than 30 
days after the date specified by the 
Secretary in the notification; and 
‘‘(III) failure to comply with the 
requirements under subclauses (I) and 
(II) shall be treated as a violation of 
the corresponding requirement of such 
paragraphs. 
‘‘(ii) CLINICAL TRIALS DESCRIBED.— 
A clinical trial described in this clause is— 
‘‘(I) an applicable clinical trial 
for a drug that is approved under sec-
tion 505 of the Federal Food, Drug, 
and Cosmetic Act or licensed under 
section 351 of this Act or for a device 
that is cleared under section 510(k) of 
the Federal Food, Drug, and Cos-
metic Act or approved under section 
515 or section 520(m) of such Act, 
whose completion date is on or after 
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‘‘(III) not later than 30 days 
after the recruitment status of such 
clinical trial changes, shall include an 
update of the recruitment status; and 
‘‘(IV) not later than 30 days 
after the completion date of the clin-
ical trial, shall include notification to 
the Director that such clinical trial is 
complete. 
‘‘(ii) PUBLIC
AVAILABILITY
OF
UP-
DATES.—The Director of NIH shall make 
updates submitted under clause (i) publicly 
available in the registry data bank. Except 
with regard to overall recruitment status, 
individual site status, location, and contact 
information, the Director of NIH shall en-
sure that updates to elements required 
under subclauses (I) to (V) of paragraph 
(2)(A)(ii) do not result in the removal of 
any information from the original submis-
sions or any preceding updates, and infor-
mation in such databases is presented in a 
manner that enables users to readily access 
each original element submission and to 
track the changes made by the updates. 
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The Director of NIH shall provide a link 
from the table of primary and secondary 
outcomes 
required 
under 
paragraph 
(3)(C)(ii) to the tracked history required 
under this clause of the primary and sec-
ondary outcome measures submitted under 
paragraph (2)(A)(ii)(I)(ll). 
‘‘(5) COORDINATION AND COMPLIANCE.— 
‘‘(A) CLINICAL
TRIALS
SUPPORTED
BY 
GRANTS FROM FEDERAL AGENCIES.— 
‘‘(i) GRANTS FROM CERTAIN FEDERAL 
AGENCIES.—If an applicable clinical trial is 
funded in whole or in part by a grant from 
any agency of the Department of Health 
and Human Services, including the Food 
and Drug Administration, the National In-
stitutes of Health, or the Agency for 
Healthcare Research and Quality, any 
grant or progress report forms required 
under such grant shall include a certifi-
cation that the responsible party has made 
all required submissions to the Director of 
NIH under paragraph (2) and (3). 
‘‘(ii) 
VERIFICATION
BY
FEDERAL 
AGENCIES.—The heads of the agencies re-
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ferred to in clause (i), as applicable, shall 
verify that the clinical trial information for 
each applicable clinical trial for which a 
grantee is the responsible party has been 
submitted under paragraph (2) and (3) be-
fore releasing any remaining funding for a 
grant or funding for a future grant to such 
grantee. 
‘‘(iii) NOTICE AND OPPORTUNITY TO 
REMEDY.—If the head of an agency re-
ferred to in clause (i), as applicable, 
verifies that a grantee has not submitted 
clinical trial information as described in 
clause (ii), such agency head shall provide 
notice to such grantee of such non-compli-
ance and allow such grantee 30 days to 
correct such non-compliance and submit 
the required clinical trial information. 
‘‘(iv) CONSULTATION
WITH
OTHER 
FEDERAL
AGENCIES.—The 
Secretary 
shall— 
‘‘(I) consult with other agencies 
that 
conduct 
research 
involving 
human subjects in accordance with 
any section of part 46 of title 45, 
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Code of Federal Regulations (or any 
successor regulations), to determine if 
any such research is an applicable 
clinical trial; and 
‘‘(II) develop with such agencies 
procedures comparable to those de-
scribed in clauses (i), (ii), and (iii) to 
ensure that clinical trial information 
for such applicable clinical trial is 
submitted under paragraph (2) and 
(3). 
‘‘(B) 
CERTIFICATION
TO
ACCOMPANY 
DRUG, BIOLOGICAL PRODUCT, AND DEVICE SUB-
MISSIONS.—At the time of submission of an ap-
plication under section 505 of the Federal 
Food, Drug, and Cosmetic Act, section 515 of 
such Act, section 520(m) of such Act, or section 
351 of this Act, or submission of a report under 
section 510(k) of such Act, such application or 
submission shall be accompanied by a certifi-
cation that all applicable requirements of this 
subsection have been met. Where available, such 
certification shall include the appropriate Na-
tional Clinical Trial control numbers. 
‘‘(C) QUALITY CONTROL.— 
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‘‘(i) 
PILOT
QUALITY
CONTROL 
PROJECT.—Until the effective date of the 
regulations issued under paragraph (3)(D), 
the Secretary, acting through the Director 
of NIH and the Commissioner of Food and 
Drugs, shall conduct a pilot project to de-
termine the optimal method of verification 
to help to ensure that the clinical trial in-
formation 
submitted 
under 
paragraph 
(3)(C) is non-promotional and is not false 
or misleading in any particular under sub-
paragraph (D). The Secretary shall use the 
publicly available information described in 
paragraph (3)(A) and any other informa-
tion available to the Secretary about appli-
cable clinical trials to verify the accuracy 
of the clinical trial information submitted 
under paragraph (3)(C). 
‘‘(ii) NOTICE OF COMPLIANCE.—If the 
Secretary determines that any clinical trial 
information was not submitted as required 
under this subsection, or was submitted 
but is false or misleading in any particular, 
the Secretary shall notify the responsible 
party and give such party an opportunity 
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to remedy such noncompliance by submit-
ting the required revised clinical trial infor-
mation not later than 30 days after such 
notification. 
‘‘(D) TRUTHFUL CLINICAL TRIAL INFOR-
MATION.— 
‘‘(i) IN GENERAL.—The clinical trial 
information submitted by a responsible 
party under this subsection shall not be 
false or misleading in any particular. 
‘‘(ii) EFFECT.—Clause (i) shall not 
have the effect of— 
‘‘(I) requiring clinical trial infor-
mation with respect to an applicable 
clinical trial to include information 
from any source other than such clin-
ical trial involved; or 
‘‘(II) requiring clinical trial infor-
mation described in paragraph (3)(D) 
to be submitted for purposes of para-
graph (3)(C). 
‘‘(E) PUBLIC NOTICES.— 
‘‘(i) NOTICE OF VIOLATIONS.—If the 
responsible party for an applicable clinical 
trial fails to submit clinical trial informa-
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‘‘(v) NON-SUBMISSION
OF
STATE-
MENT.—The notice under clause (ii) for a 
violation described in clause (ii) shall in-
clude the following statement: ‘The entry 
for this clinical trial did not contain infor-
mation on the primary and secondary out-
comes at the time of submission, as re-
quired by law. This may or may not have 
any bearing on the accuracy of the infor-
mation in the entry.’. 
‘‘(vi) COMPLIANCE
SEARCHES.—The 
Director of NIH shall provide that the 
public may easily search the registry and 
results data bank for entries that include 
notices required under this subparagraph. 
‘‘(6) LIMITATION ON DISCLOSURE OF CLINICAL 
TRIAL INFORMATION.— 
‘‘(A) IN GENERAL.—Nothing in this sub-
section (or under section 552 of title 5, United 
States Code) shall require the Secretary to pub-
licly disclose, by any means other than the reg-
istry and results data bank, information de-
scribed in subparagraph (B). 
‘‘(B) INFORMATION
DESCRIBED.—Infor-
mation described in this subparagraph is— 
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‘‘(i) information submitted to the Di-
rector of NIH under this subsection, or in-
formation of the same general nature as 
(or integrally associated with) the informa-
tion so submitted; and 
‘‘(ii) information not otherwise pub-
licly available, including because it is pro-
tected from disclosure under section 552 of 
title 5, United States Code. 
‘‘(7) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection $10,000,000 for each fiscal year.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) PROHIBITED
ACTS.—Section 301 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended by adding at the end the following: 
‘‘(jj)(1) The failure to submit the certification re-
quired by section 402(j)(5)(B) of the Public Health Serv-
ice Act, or knowingly submitting a false certification under 
such section. 
‘‘(2) The failure to submit clinical trial information 
required under subsection (j) of section 402 of the Public 
Health Service Act. 
‘‘(3) The submission of clinical trial information 
under subsection (j) of section 402 of the Public Health 
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Service Act that is false or misleading in any particular 
under paragraph (5)(D) of such subsection (j).’’. 
(2) CIVIL MONEY PENALTIES.—Subsection (f) 
of section 303 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333), as redesignated by sec-
tion 226, is amended— 
(A) by redesignating paragraphs (3), (4), 
and (5) as paragraphs (5), (6), and (7), respec-
tively; 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3)(A) Any person who violates section 301(jj) shall 
be subject to a civil monetary penalty of not more than 
$10,000 for all violations adjudicated in a single pro-
ceeding. 
‘‘(B) If a violation of section 301(jj) is not corrected 
within the 30-day period following notification under sec-
tion 402(j)(5)(C)(ii), the person shall, in addition to any 
penalty under subparagraph (A), be subject to a civil mon-
etary penalty of not more than $10,000 for each day of 
the violation after such period until the violation is cor-
rected.’’; 
(C) in paragraph (2)(C), by striking 
‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph 
(5)(A)’’; 
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(D) in paragraph (5), as so redesignated, 
by striking ‘‘paragraph (1) or (2)’’ each place 
it appears and inserting ‘‘paragraph (1), (2),or 
(3)’’; 
(E) in paragraph (6), as so redesignated, 
by striking ‘‘paragraph (3)(A)’’ and inserting 
‘‘paragraph (5)(A)’’; and 
(F) in paragraph (7), as so redesignated, 
by striking ‘‘paragraph (4)’’ each place it ap-
pears and inserting ‘‘paragraph (6)’’. 
(3) NEW DRUGS AND DEVICES.— 
(A) INVESTIGATIONAL NEW DRUGS.—Sec-
tion 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) is amended in 
paragraph (4), by adding at the end the fol-
lowing: ‘‘The Secretary shall update such regu-
lations to require inclusion in the informed con-
sent documents and process a statement that 
clinical trial information for such clinical inves-
tigation has been or will be submitted for inclu-
sion in the registry data bank pursuant to sub-
section (j) of section 402 of the Public Health 
Service Act.’’. 
(B) NEW
DRUG
APPLICATIONS.—Section 
505(b) of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 355(b)) is amended by 
adding at the end the following: 
‘‘(6) An application submitted under this sub-
section shall be accompanied by the certification re-
quired under section 402(j)(5)(B) of the Public 
Health Service Act. Such certification shall not be 
considered an element of such application.’’. 
(C) DEVICE
REPORTS
UNDER
SECTION 
510(k).—Section 510(k) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(k)) is 
amended by adding at the end the following: 
‘‘A notification submitted under this subsection that con-
tains clinical trial data for an applicable device clinical 
trial (as defined in section 402(j)(1) of the Public Health 
Service Act) shall be accompanied by the certification re-
quired under section 402(j)(5)(B) of such Act. Such cer-
tification shall not be considered an element of such notifi-
cation.’’. 
(D) DEVICE PREMARKET APPROVAL APPLI-
CATION.—Section 515(c)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
360e(c)(1)) is amended— 
(i) in subparagraph (F), by striking ‘‘; 
and’’ and inserting a semicolon; 
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(ii) by redesignating subparagraph 
(G) as subparagraph (H); and 
(iii) by inserting after subparagraph 
(F) the following: 
‘‘(G) the certification required under sec-
tion 402(j)(5)(B) of the Public Health Service 
Act (which shall not be considered an element 
of such application); and’’. 
(E) 
HUMANITARIAN
DEVICE
EXEMP-
TION.—Section 520(m)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is 
amended in the first sentence in the matter fol-
lowing subparagraph (C), by inserting at the 
end before the period ‘‘and such application 
shall include the certification required under 
section 402(j)(5)(B) of the Public Health Serv-
ice Act (which shall not be considered an ele-
ment of such application)’’. 
(c) SURVEILLANCES.—Not later than 12 months 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services shall issue guidance on 
how the requirements of section 402(j) of the Public 
Health Service Act, as added by this section, apply to a 
pediatric postmarket surveillance described in paragraph 
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(1)(A)(ii)(II) of such section 402(j) that is not a clinical 
trial. 
(d) PREEMPTION.— 
(1) IN GENERAL.—Upon the expansion of the 
registry and results data bank under section 
402(j)(3)(D) of the Public Health Service Act, as 
added by this section, no State or political subdivi-
sion of a State may establish or continue in effect 
any requirement for the registration of clinical trials 
or for the inclusion of information relating to the re-
sults of clinical trials in a database. 
(2) RULE OF CONSTRUCTION.—The fact of sub-
mission of clinical trial information, if submitted in 
compliance with subsection (j) of section 402 of the 
Public Health Service Act (as amended by this sec-
tion), that relates to a use of a drug or device not 
included in the official labeling of the approved drug 
or device shall not be construed by the Secretary of 
Health and Human Services or in any administra-
tive or judicial proceeding, as evidence of a new in-
tended use of the drug or device that is different 
from the intended use of the drug or device set forth 
in the official labeling of the drug or device. The 
availability of clinical trial information through the 
registry and results data bank under such subsection 
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under this paragraph or otherwise under-
taken by the responsible person to inves-
tigate a safety issue, the Secretary shall 
require the responsible person to periodi-
cally report to the Secretary on the status 
of such clinical trial including whether en-
rollment has begun, the number of partici-
pants enrolled, the expected completion 
date, whether any difficulties completing 
the clinical trial have been encountered, 
and registration information with respect 
to the requirements under section 402(j) of 
the Public Health Service Act. If the re-
sponsible person fails to comply with such 
timetable or violates any other requirement 
of this subparagraph, the responsible per-
son shall be considered in violation of this 
subsection, unless the responsible person 
demonstrates good cause for such non-
compliance or such other violation. The 
Secretary shall determine what constitutes 
good cause under the preceding sentence. 
‘‘(F) DISPUTE RESOLUTION.—The respon-
sible person may appeal a requirement to con-
duct a study or clinical trial under this para-
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graph using dispute resolution procedures es-
tablished by the Secretary in regulation and 
guidance. 
‘‘(4) SAFETY LABELING CHANGES REQUESTED 
BY SECRETARY.— 
‘‘(A) NEW SAFETY INFORMATION.—If the 
Secretary becomes aware of new safety informa-
tion that the Secretary believes should be in-
cluded in the labeling of the drug, the Secretary 
shall promptly notify the responsible person or, 
if the same drug approved under section 505(b) 
is not currently marketed, the holder of an ap-
proved application under 505(j). 
‘‘(B) RESPONSE TO NOTIFICATION.—Fol-
lowing notification pursuant to subparagraph 
(A), the responsible person or the holder of the 
approved application under section 505(j) shall 
within 30 days— 
‘‘(i) submit a supplement proposing 
changes to the approved labeling to reflect 
the new safety information, including 
changes to boxed warnings, contraindica-
tions, warnings, precautions, or adverse re-
actions; or 
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‘‘(ii) notify the Secretary that the re-
sponsible person or the holder of the ap-
proved application under section 505(j) 
does not believe a labeling change is war-
ranted and submit a statement detailing 
the reasons why such a change is not war-
ranted. 
‘‘(C) REVIEW.—Upon receipt of such sup-
plement, the Secretary shall promptly review 
and act upon such supplement. If the Secretary 
disagrees with the proposed changes in the sup-
plement or with the statement setting forth the 
reasons why no labeling change is necessary, 
the Secretary shall initiate discussions to reach 
agreement on whether the labeling for the drug 
should be modified to reflect the new safety in-
formation, and if so, the contents of such label-
ing changes. 
‘‘(D) 
DISCUSSIONS.—Such 
discussions 
shall not extend for more than 30 days after 
the response to the notification under subpara-
graph (B), unless the Secretary determines an 
extension of such discussion period is war-
ranted. 
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‘‘(E) ORDER.—Within 15 days of the con-
clusion of the discussions under subparagraph 
(D), the Secretary may issue an order directing 
the responsible person or the holder of the ap-
proved application under section 505(j) to make 
such a labeling change as the Secretary deems 
appropriate to address the new safety informa-
tion. Within 15 days of such an order, the re-
sponsible person or the holder of the approved 
application under section 505(j) shall submit a 
supplement containing the labeling change. 
‘‘(F) DISPUTE
RESOLUTION.—Within 5 
days of receiving an order under subparagraph 
(E), the responsible person or the holder of the 
approved application under section 505(j) may 
appeal using dispute resolution procedures es-
tablished by the Secretary in regulation and 
guidance. 
‘‘(G) VIOLATION.—If the responsible per-
son or the holder of the approved application 
under section 505(j) has not submitted a sup-
plement within 15 days of the date of such 
order under subparagraph (E), and there is no 
appeal or dispute resolution proceeding pend-
ing, the responsible person or holder shall be 
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considered to be in violation of this subsection. 
If at the conclusion of any dispute resolution 
procedures the Secretary determines that a sup-
plement must be submitted and such a supple-
ment is not submitted within 15 days of the 
date of that determination, the responsible per-
son or holder shall be in violation of this sub-
section. 
‘‘(H) PUBLIC HEALTH THREAT.—Notwith-
standing subparagraphs (A) through (F), if the 
Secretary concludes that such a labeling change 
is necessary to protect the public health, the 
Secretary may accelerate the timelines in such 
subparagraphs. 
‘‘(I) RULE OF CONSTRUCTION.—This para-
graph shall not be construed to affect the re-
sponsibility of the responsible person or the 
holder of the approved application under section 
505(j) to maintain its label in accordance with 
existing requirements, including subpart B of 
part 201 and sections 314.70 and 601.12 of 
title 21, Code of Federal Regulations (or any 
successor regulations). 
‘‘(5) 
NON-DELEGATION.—Determinations 
by 
the Secretary under this subsection for a drug shall 
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be made by individuals at or above the level of indi-
viduals empowered to approve a drug (such as divi-
sion directors within the Center for Drug Evaluation 
and Research). 
‘‘(p) RISK EVALUATION AND MITIGATION STRAT-
EGY.— 
‘‘(1) IN GENERAL.—A person may not intro-
duce or deliver for introduction into interstate com-
merce a new drug if— 
‘‘(A)(i) the application for such drug is ap-
proved under subsection (b) or (j) and is sub-
ject to section 503(b); or 
‘‘(ii) the application for such drug is ap-
proved under section 351 of the Public Health 
Service Act; and 
‘‘(B) a risk evaluation and mitigation 
strategy is required under section 505–1 with 
respect to the drug and the person fails to 
maintain compliance with the requirements of 
the approved strategy or with other require-
ments under section 505–1, including require-
ments regarding assessments of approved strat-
egies. 
‘‘(2) CERTAIN
POSTMARKET
STUDIES.—The 
failure to conduct a postmarket study under section 
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506, subpart H of part 314, or subpart E of part 
601 of title 21, Code of Federal Regulations (or any 
successor regulations), is deemed to be a violation of 
paragraph (1).’’. 
(b) REQUIREMENTS
REGARDING
STRATEGIES.— 
Chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 505 the following section: 
‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATE-
GIES. 
‘‘(a) SUBMISSION OF PROPOSED STRATEGY.— 
‘‘(1) INITIAL APPROVAL.—If the Secretary, in 
consultation with the office responsible for reviewing 
the drug and the office responsible for postapproval 
safety with respect to the drug, determines that a 
risk evaluation and mitigation strategy is necessary 
to ensure that the benefits of the drug outweigh the 
risks of the drug, and informs the person who sub-
mits such application of such determination, then 
such person shall submit to the Secretary as part of 
such application a proposed risk evaluation and miti-
gation strategy. In making such a determination, the 
Secretary shall consider the following factors: 
‘‘(A) The estimated size of the population 
likely to use the drug involved. 
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‘‘(B) The seriousness of the disease or con-
dition that is to be treated with the drug. 
‘‘(C) The expected benefit of the drug with 
respect to such disease or condition. 
‘‘(D) The expected or actual duration of 
treatment with the drug. 
‘‘(E) The seriousness of any known or po-
tential adverse events that may be related to 
the drug and the background incidence of such 
events in the population likely to use the drug. 
‘‘(F) Whether the drug is a new molecular 
entity. 
‘‘(2) POSTAPPROVAL REQUIREMENT.— 
‘‘(A) IN GENERAL.—If the Secretary has 
approved a covered application (including an 
application approved before the effective date of 
this section) and did not when approving the 
application require a risk evaluation and mitiga-
tion strategy under paragraph (1), the Sec-
retary, in consultation with the offices described 
in paragraph (1), may subsequently require 
such a strategy for the drug involved (including 
when acting on a supplemental application seek-
ing approval of a new indication for use of the 
drug) if the Secretary becomes aware of new 
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safety information and makes a determination 
that such a strategy is necessary to ensure that 
the benefits of the drug outweigh the risks of 
the drug. 
‘‘(B) SUBMISSION
OF
PROPOSED
STRAT-
EGY.—Not later than 120 days after the Sec-
retary notifies the holder of an approved cov-
ered application that the Secretary has made a 
determination under subparagraph (A) with re-
spect to the drug involved, or within such other 
reasonable time as the Secretary requires to 
protect the public health, the holder shall sub-
mit to the Secretary a proposed risk evaluation 
and mitigation strategy. 
‘‘(3) 
ABBREVIATED
NEW
DRUG
APPLICA-
TIONS.—The applicability of this section to an appli-
cation under section 505(j) is subject to subsection 
(i). 
‘‘(4) 
NON-DELEGATION.—Determinations 
by 
the Secretary under this subsection for a drug shall 
be made by individuals at or above the level of indi-
viduals empowered to approve a drug (such as divi-
sion directors within the Center for Drug Evaluation 
and Research). 
‘‘(b) DEFINITIONS.—For purposes of this section: 
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‘‘(1) ADVERSE DRUG EXPERIENCE.—The term 
‘adverse drug experience’ means any adverse event 
associated with the use of a drug in humans, wheth-
er or not considered drug related, including— 
‘‘(A) an adverse event occurring in the 
course of the use of the drug in professional 
practice; 
‘‘(B) an adverse event occurring from an 
overdose of the drug, whether accidental or in-
tentional; 
‘‘(C) an adverse event occurring from 
abuse of the drug; 
‘‘(D) an adverse event occurring from 
withdrawal of the drug; and 
‘‘(E) any failure of expected pharma-
cological action of the drug. 
‘‘(2) COVERED APPLICATION.—The term ‘cov-
ered application’ means an application referred to in 
section 505(p)(1)(A). 
‘‘(3) NEW
SAFETY
INFORMATION.—The term 
‘new safety information’, with respect to a drug, 
means information derived from a clinical trial, an 
adverse event report, a postapproval study (including 
a study under section 505(o)(3)), or peer-reviewed 
biomedical 
literature; 
data 
derived 
from 
the 
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postmarket risk identification and analysis system 
under section 505(k); or other scientific data deemed 
appropriate by the Secretary about— 
‘‘(A) a serious risk or an unexpected seri-
ous risk associated with use of the drug that 
the Secretary has become aware of (that may 
be based on a new analysis of existing informa-
tion) since the drug was approved, since the 
risk evaluation and mitigation strategy was re-
quired, or since the last assessment of the ap-
proved risk evaluation and mitigation strategy 
for the drug; or 
‘‘(B) the effectiveness of the approved risk 
evaluation and mitigation strategy for the drug 
obtained since the last assessment of such 
strategy. 
‘‘(4) SERIOUS ADVERSE DRUG EXPERIENCE.— 
The term ‘serious adverse drug experience’ is an ad-
verse drug experience that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) an adverse drug experience that 
places the patient at immediate risk of 
death from the adverse drug experience as 
it occurred (not including an adverse drug 
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experience that might have caused death 
had it occurred in a more severe form); 
‘‘(iii) inpatient hospitalization or pro-
longation of existing hospitalization; 
‘‘(iv) a persistent or significant inca-
pacity or substantial disruption of the abil-
ity to conduct normal life functions; or 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(B) based on appropriate medical judg-
ment, may jeopardize the patient and may re-
quire a medical or surgical intervention to pre-
vent an outcome described under subparagraph 
(A). 
‘‘(5) SERIOUS RISK.—The term ‘serious risk’ 
means a risk of a serious adverse drug experience. 
‘‘(6) SIGNAL OF A SERIOUS RISK.—The term 
‘signal of a serious risk’ means information related 
to a serious adverse drug experience associated with 
use of a drug and derived from— 
‘‘(A) a clinical trial; 
‘‘(B) adverse event reports; 
‘‘(C) a postapproval study, including a 
study under section 505(o)(3); 
‘‘(D) peer-reviewed biomedical literature; 
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‘‘(E) data derived from the postmarket 
risk identification and analysis system under 
section 505(k)(4); or 
‘‘(F) other scientific data deemed appro-
priate by the Secretary. 
‘‘(7) RESPONSIBLE
PERSON.—The term ‘re-
sponsible person’ means the person submitting a 
covered application or the holder of the approved 
such application. 
‘‘(8) UNEXPECTED SERIOUS RISK.—The term 
‘unexpected serious risk’ means a serious adverse 
drug experience that is not listed in the labeling of 
a drug, or that may be symptomatically and 
pathophysiologically related to an adverse drug expe-
rience identified in the labeling, but differs from 
such adverse drug experience because of greater se-
verity, specificity, or prevalence. 
‘‘(c) CONTENTS.—A proposed risk evaluation and 
mitigation strategy under subsection (a) shall— 
‘‘(1) include the timetable required under sub-
section (d); and 
‘‘(2) to the extent required by the Secretary, in 
consultation with the office responsible for reviewing 
the drug and the office responsible for postapproval 
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safety with respect to the drug, include additional 
elements described in subsections (e) and (f). 
‘‘(d) MINIMAL STRATEGY.—For purposes of sub-
section (c)(1), the risk evaluation and mitigation strategy 
for a drug shall require a timetable for submission of as-
sessments of the strategy that— 
‘‘(1) includes an assessment, by the date that is 
18 months after the strategy is initially approved; 
‘‘(2) includes an assessment by the date that is 
3 years after the strategy is initially approved; 
‘‘(3) includes an assessment in the seventh year 
after the strategy is so approved; and 
‘‘(4) subject to paragraphs (1), (2), and (3)— 
‘‘(A) is at a frequency specified in the 
strategy; 
‘‘(B) is increased or reduced in frequency 
as necessary as provided for in subsection 
(g)(4)(A); and 
‘‘(C) is eliminated after the 3-year period 
described in paragraph (1) if the Secretary de-
termines that serious risks of the drug have 
been adequately identified and assessed and are 
being adequately managed. 
‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRAT-
EGY.— 
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‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the offices described in subsection (c)(2), 
may under such subsection require that the risk 
evaluation and mitigation strategy for a drug include 
1 or more of the additional elements described in 
this subsection if the Secretary makes the deter-
mination required with respect to each element in-
volved. 
‘‘(2) MEDICATION
GUIDE; PATIENT
PACKAGE 
INSERT.—The risk evaluation and mitigation strat-
egy for a drug may require that, as applicable, the 
responsible person develop for distribution to each 
patient when the drug is dispensed— 
‘‘(A) a Medication Guide, as provided for 
under part 208 of title 21, Code of Federal 
Regulations (or any successor regulations); and 
‘‘(B) a patient package insert, if the Sec-
retary determines that such insert may help 
mitigate a serious risk of the drug. 
‘‘(3) COMMUNICATION PLAN.—The risk evalua-
tion and mitigation strategy for a drug may require 
that the responsible person conduct a communica-
tion plan to health care providers, if, with respect to 
such drug, the Secretary determines that such plan 
may support implementation of an element of the 
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strategy (including under this paragraph). Such plan 
may include— 
‘‘(A) sending letters to health care pro-
viders; 
‘‘(B) disseminating information about the 
elements of the risk evaluation and mitigation 
strategy to encourage implementation by health 
care providers of components that apply to such 
health care providers, or to explain certain safe-
ty protocols (such as medical monitoring by 
periodic laboratory tests); or 
‘‘(C) disseminating information to health 
care providers through professional societies 
about any serious risks of the drug and any 
protocol to assure safe use. 
‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO 
DRUGS WITH KNOWN SERIOUS RISKS THAT WOULD 
OTHERWISE BE UNAVAILABLE.— 
‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH 
KNOWN
SERIOUS
RISKS.—The Secretary, in con-
sultation with the offices described in subsection 
(c)(2), may require that the risk evaluation and 
mitigation strategy for a drug include such elements 
as are necessary to assure safe use of the drug, be-
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cause of its inherent toxicity or potential harmful-
ness, if the Secretary determines that— 
‘‘(A) the drug, which has been shown to be 
effective, but is associated with a serious ad-
verse drug experience, can be approved only if, 
or would be withdrawn unless, such elements 
are required as part of such strategy to miti-
gate a specific serious risk listed in the labeling 
of the drug; and 
‘‘(B) for a drug initially approved without 
elements to assure safe use, other elements 
under subsections (c), (d), and (e) are not suffi-
cient to mitigate such serious risk. 
‘‘(2) ASSURING ACCESS AND MINIMIZING BUR-
DEN.—Such elements to assure safe use under para-
graph (1) shall— 
‘‘(A) be commensurate with the specific se-
rious risk listed in the labeling of the drug; 
‘‘(B) within 30 days of the date on which 
any element under paragraph (1) is imposed, be 
posted publicly by the Secretary with an expla-
nation of how such elements will mitigate the 
observed safety risk; 
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‘‘(C) considering such risk, not be unduly 
burdensome on patient access to the drug, con-
sidering in particular— 
‘‘(i) patients with serious or life- 
threatening diseases or conditions; and 
‘‘(ii) patients who have difficulty ac-
cessing health care (such as patients in 
rural or medically underserved areas); and 
‘‘(D) to the extent practicable, so as to 
minimize the burden on the health care delivery 
system— 
‘‘(i) conform with elements to assure 
safe use for other drugs with similar, seri-
ous risks; and 
‘‘(ii) be designed to be compatible 
with established distribution, procurement, 
and dispensing systems for drugs. 
‘‘(3) ELEMENTS TO ASSURE SAFE USE.—The 
elements to assure safe use under paragraph (1) 
shall include 1 or more goals to mitigate a specific 
serious risk listed in the labeling of the drug and, 
to mitigate such risk, may require that— 
‘‘(A) health care providers who prescribe 
the drug have particular training or experience, 
or are specially certified (the opportunity to ob-
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tain such training or certification with respect 
to the drug shall be available to any willing pro-
vider from a frontier area in a widely available 
training or certification method (including an 
on-line course or via mail) as approved by the 
Secretary at reasonable cost to the provider); 
‘‘(B) pharmacies, practitioners, or health 
care settings that dispense the drug are spe-
cially certified (the opportunity to obtain such 
certification shall be available to any willing 
provider from a frontier area); 
‘‘(C) the drug be dispensed to patients only 
in certain health care settings, such as hos-
pitals; 
‘‘(D) the drug be dispensed to patients 
with evidence or other documentation of safe- 
use conditions, such as laboratory test results; 
‘‘(E) each patient using the drug be sub-
ject to certain monitoring; or 
‘‘(F) each patient using the drug be en-
rolled in a registry. 
‘‘(4) IMPLEMENTATION SYSTEM.—The elements 
to assure safe use under paragraph (1) that are de-
scribed in subparagraphs (B), (C), and (D) of para-
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graph (3) may include a system through which the 
applicant is able to take reasonable steps to— 
‘‘(A) monitor and evaluate implementation 
of such elements by health care providers, phar-
macists, and other parties in the health care 
system who are responsible for implementing 
such elements; and 
‘‘(B) work to improve implementation of 
such elements by such persons. 
‘‘(5) EVALUATION OF ELEMENTS TO ASSURE 
SAFE USE.—The Secretary, through the Drug Safety 
and Risk Management Advisory Committee (or suc-
cessor committee) of the Food and Drug Adminis-
tration, shall— 
‘‘(A) seek input from patients, physicians, 
pharmacists, and other health care providers 
about how elements to assure safe use under 
this subsection for 1 or more drugs may be 
standardized so as not to be— 
‘‘(i) unduly burdensome on patient ac-
cess to the drug; and 
‘‘(ii) to the extent practicable, mini-
mize the burden on the health care delivery 
system; 
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‘‘(B) at least annually, evaluate, for 1 or 
more drugs, the elements to assure safe use of 
such drug to assess whether the elements— 
‘‘(i) assure safe use of the drug; 
‘‘(ii) are not unduly burdensome on 
patient access to the drug; and 
‘‘(iii) to the extent practicable, mini-
mize the burden on the health care delivery 
system; and 
‘‘(C) considering such input and evalua-
tions— 
‘‘(i) issue or modify agency guidance 
about how to implement the requirements 
of this subsection; and 
‘‘(ii) modify elements under this sub-
section for 1 or more drugs as appropriate. 
‘‘(6) ADDITIONAL MECHANISMS TO ASSURE AC-
CESS.—The mechanisms under section 561 to pro-
vide for expanded access for patients with serious or 
life-threatening diseases or conditions may be used 
to provide access for patients with a serious or life- 
threatening disease or condition, the treatment of 
which is not an approved use for the drug, to a drug 
that is subject to elements to assure safe use under 
this subsection. The Secretary shall promulgate reg-
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ulations for how a physician may provide the drug 
under the mechanisms of section 561. 
‘‘(7) WAIVER
IN
PUBLIC
HEALTH
EMER-
GENCIES.—The Secretary may waive any require-
ment of this subsection during the period described 
in section 319(a) of the Public Health Service Act 
with respect to a qualified countermeasure described 
under section 319F–1(a)(2) of such Act, to which a 
requirement under this subsection has been applied, 
if the Secretary has— 
‘‘(A) declared a public health emergency 
under such section 319; and 
‘‘(B) determined that such waiver is re-
quired to mitigate the effects of, or reduce the 
severity of, such public health emergency. 
‘‘(8) LIMITATION.—No holder of an approved 
covered application shall use any element to assure 
safe use required by the Secretary under this sub-
section to block or delay approval of an application 
under section 505(b)(2) or (j) or to prevent applica-
tion of such element under subsection (i)(1)(B) to a 
drug that is the subject of an abbreviated new drug 
application. 
‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED 
STRATEGY.— 
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‘‘(1) VOLUNTARY ASSESSMENTS.—After the ap-
proval of a risk evaluation and mitigation strategy 
under subsection (a), the responsible person involved 
may, subject to paragraph (2), submit to the Sec-
retary an assessment of, and propose a modification 
to, the approved strategy for the drug involved at 
any time. 
‘‘(2) REQUIRED ASSESSMENTS.—A responsible 
person shall, subject to paragraph (5), submit an as-
sessment of, and may propose a modification to, the 
approved risk evaluation and mitigation strategy for 
a drug— 
‘‘(A) when submitting a supplemental ap-
plication for a new indication for use under sec-
tion 505(b) or under section 351 of the Public 
Health Service Act, unless the drug is not sub-
ject to section 503(b) and the risk evaluation 
and mitigation strategy for the drug includes 
only the timetable under subsection (d); 
‘‘(B) when required by the strategy, as 
provided for in such timetable under subsection 
(d); 
‘‘(C) within a time period to be determined 
by the Secretary, if the Secretary, in consulta-
tion with the offices described in subsection 
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(c)(2), determines that new safety or effective-
ness information indicates that— 
‘‘(i) an element under subsection (d) 
or (e) should be modified or included in 
the strategy; or 
‘‘(ii) an element under subsection (f) 
should be modified or included in the strat-
egy; or 
‘‘(D) within 15 days when ordered by the 
Secretary, in consultation with the offices de-
scribed in subsection (c)(2), if the Secretary de-
termines that there may be a cause for action 
by the Secretary under section 505(e). 
‘‘(3) REQUIREMENTS FOR ASSESSMENTS.—An 
assessment under paragraph (1) or (2) of an ap-
proved risk evaluation and mitigation strategy for a 
drug shall include— 
‘‘(A) with respect to any goal under sub-
section (f), an assessment of the extent to 
which the elements to assure safe use are meet-
ing the goal or whether the goal or such ele-
ments should be modified; 
‘‘(B) with respect to any postapproval 
study required under section 505(o) or other-
wise undertaken by the responsible person to 
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