220 
of a drug subject to section 505 of the 
Federal Food, Drug, and Cosmetic 
Act or to section 351 of this Act. 
‘‘(II) 
CLINICAL
INVESTIGA-
TION.—For purposes of subclause (I), 
the term ‘clinical investigation’ has 
the meaning given that term in sec-
tion 312.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tion). 
‘‘(III) PHASE
I.—For purposes 
of subclause (I), the term ‘phase I’ 
has the meaning given that term in 
section 312.21 of title 21, Code of 
Federal Regulations (or any successor 
regulation). 
‘‘(iv) 
CLINICAL
TRIAL
INFORMA-
TION.—The term ‘clinical trial information’ 
means, with respect to an applicable clin-
ical trial, those data elements that the re-
sponsible party is required to submit under 
paragraph (2) or under paragraph (3). 
‘‘(v) COMPLETION
DATE.—The term 
‘completion date’ means, with respect to an 
applicable clinical trial, the date that the
221 
final subject was examined or received an 
intervention for the purposes of final col-
lection of data for the primary outcome, 
whether the clinical trial concluded accord-
ing to the prespecified protocol or was ter-
minated. 
‘‘(vi) DEVICE.—The term ‘device’ 
means a device as defined in section 
201(h) of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(vii) DRUG.—The term ‘drug’ means 
a drug as defined in section 201(g) of the 
Federal Food, Drug, and Cosmetic Act or 
a biological product as defined in section 
351 of this Act. 
‘‘(viii) ONGOING.—The term ‘ongoing’ 
means, with respect to a clinical trial of a 
drug or a device and to a date, that— 
‘‘(I) 1 or more patients is en-
rolled in the clinical trial; and 
‘‘(II) the date is before the com-
pletion date of the clinical trial. 
‘‘(ix) 
RESPONSIBLE
PARTY.—The 
term ‘responsible party’, with respect to a 
clinical trial of a drug or device, means—
222 
‘‘(I) the sponsor of the clinical 
trial (as defined in section 50.3 of 
title 21, Code of Federal Regulations 
(or any successor regulation)); or 
‘‘(II) the principal investigator of 
such clinical trial if so designated by 
a sponsor, grantee, contractor, or 
awardee, so long as the principal in-
vestigator is responsible for con-
ducting the trial, has access to and 
control over the data from the clinical 
trial, has the right to publish the re-
sults of the trial, and has the ability 
to meet all of the requirements under 
this subsection for the submission of 
clinical trial information. 
‘‘(B) REQUIREMENT.—The Secretary shall 
develop a mechanism by which the responsible 
party for each applicable clinical trial shall sub-
mit the identity and contact information of such 
responsible party to the Secretary at the time 
of submission of clinical trial information under 
paragraph (2).
223 
‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY 
DATA BANK WITH RESPECT TO CLINICAL TRIAL IN-
FORMATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) EXPANSION OF DATA BANK.—To 
enhance patient enrollment and provide a 
mechanism to track subsequent progress of 
clinical 
trials, 
the 
Secretary, 
acting 
through the Director of NIH, shall expand, 
in accordance with this subsection, the 
clinical trials registry of the data bank de-
scribed under subsection (i)(1) (referred to 
in this subsection as the ‘registry data 
bank’). The Director of NIH shall ensure 
that the registry data bank is made pub-
licly available through the Internet. 
‘‘(ii) CONTENT.—The clinical trial in-
formation required to be submitted under 
this paragraph for an applicable clinical 
trial shall include— 
‘‘(I) descriptive information, in-
cluding— 
‘‘(aa) a brief title, intended 
for the lay public;
224 
‘‘(bb) a brief summary, in-
tended for the lay public; 
‘‘(cc) the primary purpose; 
‘‘(dd) the study design; 
‘‘(ee) for an applicable drug 
clinical trial, the study phase; 
‘‘(ff) study type; 
‘‘(gg) the primary disease or 
condition being studied, or the 
focus of the study; 
‘‘(hh) the intervention name 
and intervention type; 
‘‘(ii) the study start date; 
‘‘(jj) the expected completion 
date; 
‘‘(kk) the target number of 
subjects; and 
‘‘(ll) outcomes, including pri-
mary and secondary outcome 
measures; 
‘‘(II) recruitment information, in-
cluding— 
‘‘(aa) eligibility criteria; 
‘‘(bb) gender; 
‘‘(cc) age limits;
225 
‘‘(dd) whether the trial ac-
cepts healthy volunteers; 
‘‘(ee) 
overall 
recruitment 
status; 
‘‘(ff) individual site status; 
and 
‘‘(gg) in the case of an ap-
plicable drug clinical trial, if the 
drug is not approved under sec-
tion 505 of the Federal Food, 
Drug, and Cosmetic Act or li-
censed under section 351 of this 
Act, specify whether or not there 
is expanded access to the drug 
under section 561 of the Federal 
Food, Drug, and Cosmetic Act 
for those who do not qualify for 
enrollment in the clinical trial 
and how to obtain information 
about such access; 
‘‘(III) location and contact infor-
mation, including— 
‘‘(aa) the name of the spon-
sor;
226 
‘‘(bb) the responsible party, 
by official title; and 
‘‘(cc) the facility name and 
facility contact information (in-
cluding the city, State, and zip 
code for each clinical trial loca-
tion, 
or 
a 
toll-free 
number 
through which such location in-
formation may be accessed); and 
‘‘(IV) administrative data (which 
the Secretary may make publicly 
available as necessary), including— 
‘‘(aa) the unique protocol 
identification number; 
‘‘(bb) other protocol identi-
fication numbers, if any; and 
‘‘(cc) the Food and Drug 
Administration 
IND/IDE 
pro-
tocol number and the record 
verification date. 
‘‘(iii) 
MODIFICATIONS.—The 
Sec-
retary may by regulation modify the re-
quirements for clinical trial information 
under this paragraph, if the Secretary pro-
vides a rationale for why such a modifica-
227 
tion improves and does not reduce such 
clinical trial information. 
‘‘(B) FORMAT AND STRUCTURE.— 
‘‘(i) SEARCHABLE CATEGORIES.—The 
Director of NIH shall ensure that the pub-
lic may, in addition to keyword searching, 
search the entries in the registry data bank 
by 1 or more of the following criteria: 
‘‘(I) The disease or condition 
being studied in the clinical trial, 
using 
Medical 
Subject 
Headers 
(MeSH) descriptors. 
‘‘(II) The name of the interven-
tion, including any drug or device 
being studied in the clinical trial. 
‘‘(III) The location of the clinical 
trial. 
‘‘(IV) The age group studied in 
the clinical trial, including pediatric 
subpopulations. 
‘‘(V) The study phase of the clin-
ical trial. 
‘‘(VI) The sponsor of the clinical 
trial, which may be the National Insti-
tutes of Health or another Federal
228 
agency, a private industry source, or a 
university or other organization. 
‘‘(VII) The recruitment status of 
the clinical trial. 
‘‘(VIII) The National Clinical 
Trial number or other study identi-
fication for the clinical trial. 
‘‘(ii) ADDITIONAL SEARCHABLE CAT-
EGORY.—Not later than 18 months after 
the date of the enactment of the Food and 
Drug Administration Amendments Act of 
2007, the Director of NIH shall ensure 
that the public may search the entries of 
the registry data bank by the safety issue, 
if any, being studied in the clinical trial as 
a primary or secondary outcome. 
‘‘(iii) OTHER ELEMENTS.—The Direc-
tor of NIH shall also ensure that the pub-
lic may search the entries of the registry 
data bank by such other elements as the 
Director deems necessary on an ongoing 
basis. 
‘‘(iv) FORMAT.—The Director of the 
NIH shall ensure that the registry data
229 
bank is easily used by the public, and that 
entries are easily compared. 
‘‘(C) DATA SUBMISSION.—The responsible 
party for an applicable clinical trial, including 
an applicable drug clinical trial for a serious or 
life-threatening disease or condition, that is ini-
tiated after, or is ongoing on the date that is 
90 days after, the date of the enactment of the 
Food and Drug Administration Amendments 
Act of 2007, shall submit to the Director of 
NIH for inclusion in the registry data bank the 
clinical trial information described in of sub-
paragraph (A)(ii) not later than the later of— 
‘‘(i) 90 days after such date of enact-
ment; 
‘‘(ii) 21 days after the first patient is 
enrolled in such clinical trial; or 
‘‘(iii) in the case of a clinical trial that 
is not for a serious or life-threatening dis-
ease or condition and that is ongoing on 
such date of enactment, 1 year after such 
date of enactment. 
‘‘(D) POSTING OF DATA.— 
‘‘(i) 
APPLICABLE
DRUG
CLINICAL 
TRIAL.—The Director of NIH shall ensure
230 
that clinical trial information for an appli-
cable drug clinical trial submitted in ac-
cordance with this paragraph is posted in 
the registry data bank not later than 30 
days after such submission. 
‘‘(ii) APPLICABLE
DEVICE
CLINICAL 
TRIAL.—The Director of NIH shall ensure 
that clinical trial information for an appli-
cable device clinical trial submitted in ac-
cordance with this paragraph is posted 
publicly in the registry data bank— 
‘‘(I) not earlier than the date of 
clearance under section 510(k) of the 
Federal Food, Drug, and Cosmetic 
Act, or approval under section 515 or 
520(m) of such Act, as applicable, for 
a device that was not previously 
cleared or approved, and not later 
than 30 days after such date; or 
‘‘(II) for a device that was pre-
viously cleared or approved, not later 
than 30 days after the clinical trial in-
formation under paragraph (3)(C) is 
required to be posted by the Sec-
retary.
231 
‘‘(3) EXPANSION OF REGISTRY DATA BANK TO 
INCLUDE RESULTS OF CLINICAL TRIALS.— 
‘‘(A) LINKING REGISTRY DATA BANK TO 
EXISTING RESULTS.— 
‘‘(i) IN
GENERAL.—Beginning not 
later than 90 days after the date of the en-
actment of the Food and Drug Administra-
tion Amendments Act of 2007, for those 
clinical trials that form the primary basis 
of an efficacy claim or are conducted after 
the drug involved is approved or after the 
device involved is cleared or approved, the 
Secretary shall ensure that the registry 
data bank includes links to results infor-
mation as described in clause (ii) for such 
clinical trial— 
‘‘(I) not earlier than 30 days 
after the date of the approval of the 
drug involved or clearance or approval 
of the device involved; or 
‘‘(II) not later than 30 days after 
the results information described in 
clause (ii) becomes publicly available. 
‘‘(ii) REQUIRED INFORMATION.—
232 
‘‘(I) FDA INFORMATION.—The 
Secretary shall ensure that the reg-
istry data bank includes links to the 
following information: 
‘‘(aa) If an advisory com-
mittee considered at a meeting 
an applicable clinical trial, any 
posted Food and Drug Adminis-
tration summary document re-
garding such applicable clinical 
trial. 
‘‘(bb) If an applicable drug 
clinical trial was conducted under 
section 505A or 505B of the 
Federal Food, Drug, and Cos-
metic Act, a link to the posted 
Food and Drug Administration 
assessment of the results of such 
trial. 
‘‘(cc) Food and Drug Ad-
ministration 
public 
health 
advisories regarding the drug or 
device that is the subject of the 
applicable clinical trial, if any.
233 
‘‘(dd) For an applicable 
drug clinical trial, the Food and 
Drug 
Administration 
action 
package for approval document 
required under section 505(l)(2) 
of the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(ee) For an applicable de-
vice clinical trial, in the case of a 
premarket application under sec-
tion 515 of the Federal Food, 
Drug, and Cosmetic Act, the de-
tailed summary of information 
respecting the safety and effec-
tiveness of the device required 
under section 520(h)(1) of such 
Act, or, in the case of a report 
under section 510(k) of such Act, 
the section 510(k) summary of 
the safety and effectiveness data 
required under section 807.95(d) 
of title 21, Code of Federal Reg-
ulations (or any successor regula-
tion).
238 
of the enactment of the Food and Drug 
Administration Amendments Act of 2007, 
the Secretary shall by regulation expand 
the registry and results data bank as pro-
vided under this subparagraph. 
‘‘(ii) CLINICAL TRIALS.— 
‘‘(I) APPROVED PRODUCTS.—The 
regulations under this subparagraph 
shall require the inclusion of the re-
sults information described in clause 
(iii) for— 
‘‘(aa) each applicable drug 
clinical trial for a drug that is 
approved under section 505 of 
the Federal Food, Drug, and 
Cosmetic Act or licensed under 
section 351 of this Act; and 
‘‘(bb) each applicable device 
clinical trial for a device that is 
cleared under section 510(k) of 
the Federal Food, Drug, and 
Cosmetic Act or approved under 
section 515 or 520(m) of such 
Act.
239 
‘‘(II) UNAPPROVED PRODUCTS.— 
The regulations under this subpara-
graph shall establish whether or not 
the results information described in 
clause (iii) shall be required for— 
‘‘(aa) an applicable drug 
clinical trial for a drug that is 
not approved under section 505 
of the Federal Food, Drug, and 
Cosmetic Act and not licensed 
under section 351 of this Act 
(whether approval or licensure 
was sought or not); and 
‘‘(bb) an applicable device 
clinical trial for a device that is 
not cleared under section 510(k) 
of the Federal Food, Drug, and 
Cosmetic Act and not approved 
under section 515 or section 
520(m) of such Act (whether 
clearance or approval was sought 
or not). 
‘‘(iii) 
REQUIRED
ELEMENTS.—The 
regulations under this subparagraph shall 
require, in addition to the elements de-
240 
scribed in subparagraph (C), information 
within each of the following categories: 
‘‘(I) A summary of the clinical 
trial and its results that is written in 
non-technical, 
understandable 
lan-
guage for patients, if the Secretary 
determines that such types of sum-
mary can be included without being 
misleading or promotional. 
‘‘(II) A summary of the clinical 
trial and its results that is technical 
in nature, if the Secretary determines 
that such types of summary can be in-
cluded without being misleading or 
promotional. 
‘‘(III) The full protocol or such 
information on the protocol for the 
trial as may be necessary to help to 
evaluate the results of the trial. 
‘‘(IV) Such other categories as 
the Secretary determines appropriate. 
‘‘(iv) RESULTS SUBMISSION.—The re-
sults information described in clause (iii) 
shall be submitted to the Director of NIH 
for inclusion in the registry and results
241 
data bank as provided by subparagraph 
(E), except that the Secretary shall by reg-
ulation determine— 
‘‘(I) whether the 1-year period 
for submission of clinical trial infor-
mation described in subparagraph 
(E)(i) should be increased from 1 year 
to a period not to exceed 18 months; 
‘‘(II) whether the clinical trial in-
formation described in clause (iii) 
should be required to be submitted for 
an applicable clinical trial for which 
the clinical trial information described 
in subparagraph (C) is submitted to 
the registry and results data bank be-
fore the effective date of the regula-
tions issued under this subparagraph; 
and 
‘‘(III) in the case when the clin-
ical trial information described in 
clause (iii) is required to be submitted 
for the applicable clinical trials de-
scribed in clause (ii)(II), the date by 
which such clinical trial information
242 
shall be required to be submitted, tak-
ing into account— 
‘‘(aa) the certification proc-
ess under subparagraph (E)(iii) 
when 
approval, 
licensure, 
or 
clearance is sought; and 
‘‘(bb) whether there should 
be a delay of submission when 
approval, licensure, or clearance 
will not be sought. 
‘‘(v) ADDITIONAL
PROVISIONS.—The 
regulations under this subparagraph shall 
also establish— 
‘‘(I) a standard format for the 
submission of clinical trial information 
under this paragraph to the registry 
and results data bank; 
‘‘(II) additional information on 
clinical trials and results that is writ-
ten in nontechnical, understandable 
language for patients; 
‘‘(III) considering the experience 
under the pilot quality control project 
described in paragraph (5)(C), proce-
dures for quality control, including
245 
regulation under subparagraph (D), after 
the earlier of— 
‘‘(I) the estimated completion 
date of the trial as described in para-
graph (2)(A)(ii)(I)(jj)); or 
‘‘(II) the actual date of comple-
tion. 
‘‘(ii) CLINICAL TRIALS DESCRIBED.— 
An applicable clinical trial described in this 
clause is an applicable clinical trial subject 
to— 
‘‘(I) paragraph (2)(C); and 
‘‘(II)(aa) subparagraph (C); or 
‘‘(bb) 
the 
regulations 
issued 
under subparagraph (D). 
‘‘(iii) DELAYED SUBMISSION OF RE-
SULTS
WITH
CERTIFICATION.—If the re-
sponsible party for an applicable clinical 
trial submits a certification that clause (iv) 
or (v) applies to such clinical trial, the re-
sponsible party shall submit to the Direc-
tor of NIH for inclusion in the registry 
and results data bank the clinical trial in-
formation described in subparagraphs (C)
246 
and (D) as required under the applicable 
clause. 
‘‘(iv) SEEKING INITIAL APPROVAL OF 
A DRUG OR DEVICE.—With respect to an 
applicable clinical trial that is completed 
before the drug is initially approved under 
section 505 of the Federal Food, Drug, 
and Cosmetic Act or initially licensed 
under section 351 of this Act, or the device 
is initially cleared under section 510(k) or 
initially approved under section 515 or 
520(m) of the Federal Food, Drug, and 
Cosmetic Act, the responsible party shall 
submit to the Director of NIH for inclu-
sion in the registry and results data bank 
the clinical trial information described in 
subparagraphs (C) and (D) not later than 
30 days after the drug or device is ap-
proved under such section 505, licensed 
under such section 351, cleared under such 
section 510(k), or approved under such 
section 515 or 520(m), as applicable. 
‘‘(v) SEEKING APPROVAL OF A NEW 
USE FOR THE DRUG OR DEVICE.—
247 
‘‘(I) IN GENERAL.—With respect 
to an applicable clinical trial where 
the manufacturer of the drug or de-
vice is the sponsor of an applicable 
clinical trial, and such manufacturer 
has filed, or will file within 1 year, an 
application seeking approval under 
section 505 of the Federal Food, 
Drug, and Cosmetic Act, licensing 
under section 351 of this Act, or 
clearance under section 510(k), or ap-
proval under section 515 or 520(m), 
of the Federal Food, Drug, and Cos-
metic Act for the use studied in such 
clinical trial (which use is not included 
in the labeling of the approved drug 
or device), then the responsible party 
shall submit to the Director of NIH 
for inclusion in the registry and re-
sults data bank the clinical trial infor-
mation described in subparagraphs 
(C) and (D) on the earlier of the date 
that is 30 days after the date— 
‘‘(aa) the new use of the 
drug or device is approved under
248 
such section 505, licensed under 
such section 351, cleared under 
such section 510(k), or approved 
under 
such 
section 
515 
or 
520(m); 
‘‘(bb) the Secretary issues a 
letter, such as a complete re-
sponse letter, not approving the 
submission or not clearing the 
submission, a not approvable let-
ter, or a not substantially equiva-
lent letter for the new use of the 
drug or device under such section 
505, 
351, 
510(k), 
515, 
or 
520(m); or 
‘‘(cc) except as provided in 
subclause (III), the application or 
premarket 
notification 
under 
such section 505, 351, 510(k), 
515, or 520(m) is withdrawn 
without resubmission for no less 
than 210 days. 
‘‘(II) REQUIREMENT THAT EACH 
CLINICAL TRIAL IN APPLICATION BE 
TREATED THE SAME.—If a manufac-
256 
the date 10 years before the date of 
the enactment of the Food and Drug 
Administration Amendments Act of 
2007; or 
‘‘(II) an applicable clinical trial 
that is described by both by para-
graph 
(2)(C) 
and 
paragraph 
(3)(D)(ii)(II)). 
‘‘(C) UPDATES TO CLINICAL TRIAL DATA 
BANK.— 
‘‘(i) SUBMISSION OF UPDATES.—The 
responsible party for an applicable clinical 
trial shall submit to the Director of NIH 
for inclusion in the registry and results 
data bank updates to reflect changes to the 
clinical trial information submitted under 
paragraph (2). Such updates— 
‘‘(I) shall be provided not less 
than once every 12 months, unless 
there were no changes to the clinical 
trial information during the preceding 
12-month period; 
‘‘(II) shall include identification 
of the dates of any such changes;
257 
‘‘(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.
258 
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-
259 
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,
260 
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.—
261 
‘‘(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
262 
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-
263 
tion for such clinical trial as required 
under paragraphs (2) or (3), the Director 
of NIH shall include in the registry and re-
sults data bank entry for such clinical trial 
a notice— 
‘‘(I) that the responsible party is 
not in compliance with this Act by— 
‘‘(aa) failing to submit re-
quired clinical trial information; 
or 
‘‘(bb) submitting false or 
misleading clinical trial informa-
tion; 
‘‘(II) of the penalties imposed for 
the violation, if any; and 
‘‘(III) whether the responsible 
party has corrected the clinical trial 
information in the registry and results 
data bank. 
‘‘(ii) NOTICE OF FAILURE TO SUBMIT 
PRIMARY AND SECONDARY OUTCOMES.—If 
the responsible party for an applicable clin-
ical trial fails to submit the primary and 
secondary outcomes as required under sec-
tion 2(A)(ii)(I)(ll), the Director of NIH
264 
shall include in the registry and results 
data bank entry for such clinical trial a no-
tice that the responsible party is not in 
compliance by failing to register the pri-
mary and secondary outcomes in accord-
ance with this act, and that the primary 
and secondary outcomes were not publicly 
disclosed in the database before conducting 
the clinical trial. 
‘‘(iii) FAILURE
TO
SUBMIT
STATE-
MENT.—The notice under clause (i) for a 
violation described in clause (i)(I)(aa) shall 
include the following statement: ‘The entry 
for this clinical trial was not complete at 
the time of submission, as required by law. 
This may or may not have any bearing on 
the accuracy of the information in the 
entry.’. 
‘‘(iv) SUBMISSION OF FALSE INFOR-
MATION
STATEMENT.—The notice under 
clause (i) for a violation described in clause 
(i)(I)(bb) shall include the following state-
ment: ‘The entry for this clinical trial was 
found to be false or misleading and there-
fore not in compliance with the law.’.
265 
‘‘(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—
266 
‘‘(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
269 
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;
270 
(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
271 
(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
272 
(j), if submitted in compliance with such subsection, 
shall not be considered as labeling, adulteration, or 
misbranding of the drug or device under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). 
TITLE IX—ENHANCED AUTHORI-
TIES 
REGARDING 
POSTMARKET 
SAFETY 
OF 
DRUGS 
Subtitle A—Postmarket Studies 
and Surveillance 
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS RE-
GARDING HUMAN DRUGS; RISK EVALUATION 
AND MITIGATION STRATEGIES. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following subsections: 
‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; 
LABELING.— 
‘‘(1) IN GENERAL.—A responsible person may 
not introduce or deliver for introduction into inter-
state commerce the new drug involved if the person 
is in violation of a requirement established under 
paragraph (3) or (4) with respect to the drug.
273 
‘‘(2) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) RESPONSIBLE
PERSON.—The term 
‘responsible person’ means a person who— 
‘‘(i) has submitted to the Secretary a 
covered application that is pending; or 
‘‘(ii) is the holder of an approved cov-
ered application. 
‘‘(B) COVERED
APPLICATION.—The term 
‘covered application’ means— 
‘‘(i) an application under subsection 
(b) for a drug that is subject to section 
503(b); and 
‘‘(ii) an application under section 351 
of the Public Health Service Act. 
‘‘(C) NEW SAFETY INFORMATION; SERIOUS 
RISK.—The terms ‘new safety information’, ‘se-
rious risk’, and ‘signal of a serious risk’ have 
the meanings given such terms in section 505– 
1(b). 
‘‘(3) STUDIES AND CLINICAL TRIALS.— 
‘‘(A) IN GENERAL.—For any or all of the 
purposes specified in subparagraph (B), the 
Secretary may, subject to subparagraph (D), 
require a responsible person for a drug to con-
274 
duct a postapproval study or studies of the 
drug, or a postapproval clinical trial or trials of 
the drug, on the basis of scientific data deemed 
appropriate by the Secretary, including infor-
mation regarding chemically-related or pharma-
cologically-related drugs. 
‘‘(B) PURPOSES OF STUDY OR CLINICAL 
TRIAL.—The purposes referred to in this sub-
paragraph with respect to a postapproval study 
or postapproval clinical trial are the following: 
‘‘(i) To assess a known serious risk 
related to the use of the drug involved. 
‘‘(ii) To assess signals of serious risk 
related to the use of the drug. 
‘‘(iii) To identify an unexpected seri-
ous risk when available data indicates the 
potential for a serious risk. 
‘‘(C) ESTABLISHMENT
OF
REQUIREMENT 
AFTER APPROVAL OF COVERED APPLICATION.— 
The Secretary may require a postapproval study 
or studies or postapproval clinical trial or trials 
for a drug for which an approved covered appli-
cation is in effect as of the date on which the 
Secretary seeks to establish such requirement
275 
only if the Secretary becomes aware of new 
safety information. 
‘‘(D) DETERMINATION BY SECRETARY.— 
‘‘(i) POSTAPPROVAL
STUDIES.—The 
Secretary may not require the responsible 
person to conduct a study under this para-
graph, unless the Secretary makes a deter-
mination that the reports under subsection 
(k)(1) and the active postmarket risk iden-
tification and analysis system as available 
under subsection (k)(3) will not be suffi-
cient to meet the purposes set forth in sub-
paragraph (B). 
‘‘(ii) 
POSTAPPROVAL
CLINICAL 
TRIALS.—The Secretary may not require 
the responsible person to conduct a clinical 
trial under this paragraph, unless the Sec-
retary makes a determination that a post-
approval study or studies will not be suffi-
cient to meet the purposes set forth in sub-
paragraph (B). 
‘‘(E) NOTIFICATION; TIMETABLES; PERI-
ODIC REPORTS.— 
‘‘(i) NOTIFICATION.—The Secretary 
shall notify the responsible person regard-
276 
ing a requirement under this paragraph to 
conduct a postapproval study or clinical 
trial by the target dates for communication 
of feedback from the review team to the re-
sponsible person regarding proposed label-
ing and postmarketing study commitments 
as set forth in the letters described in sec-
tion 101(c) of the Food and Drug Admin-
istration Amendments Act of 2007. 
‘‘(ii) 
TIMETABLE; 
PERIODIC
RE-
PORTS.—For each study or clinical trial re-
quired to be conducted under this para-
graph, the Secretary shall require that the 
responsible person submit a timetable for 
completion of the study or clinical trial. 
With respect to each study required to be 
conducted under this paragraph or other-
wise undertaken by the responsible person 
to investigate a safety issue, the Secretary 
shall require the responsible person to peri-
odically report to the Secretary on the sta-
tus of such study including whether any 
difficulties in completing the study have 
been encountered. With respect to each 
clinical trial required to be conducted
277 
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-
278 
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
279 
‘‘(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.
280 
‘‘(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
281 
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
283 
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.
284 
‘‘(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
285 
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:
286 
‘‘(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
287 
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
288 
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;
299 
‘‘(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
300 
(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
301 
investigate a safety issue, the status of such 
study, including whether any difficulties com-
pleting the study have been encountered; and 
‘‘(C) with respect to any postapproval clin-
ical trial required under section 505(o) or oth-
erwise undertaken by the responsible party to 
investigate a safety issue, the status of such 
clinical trial, including whether enrollment has 
begun, the number of participants enrolled, the 
expected completion date, whether any difficul-
ties completing the clinical trial have been en-
countered, and registration information with re-
spect to requirements under subsections (i) and 
(j) of section 402 of the Public Health Service 
Act. 
‘‘(4) MODIFICATION.—A modification (whether 
an enhancement or a reduction) to the approved risk 
evaluation and mitigation strategy for a drug may 
include the addition or modification of any element 
under subsection (d) or the addition, modification, 
or removal of any element under subsection (e) or 
(f), such as— 
‘‘(A) modifying the timetable for assess-
ments of the strategy as provided in subsection 
(d)(3), including to eliminate assessments; or
302 
‘‘(B) adding, modifying, or removing an 
element to assure safe use under subsection (f). 
‘‘(h) REVIEW OF PROPOSED STRATEGIES; REVIEW 
OF ASSESSMENTS OF APPROVED STRATEGIES.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the offices described in subsection (c)(2), 
shall promptly review each proposed risk evaluation 
and mitigation strategy for a drug submitted under 
subsection (a) and each assessment of an approved 
risk evaluation and mitigation strategy for a drug 
submitted under subsection (g). 
‘‘(2) DISCUSSION.—The Secretary, in consulta-
tion with the offices described in subsection (c)(2), 
shall initiate discussions with the responsible person 
for purposes of this subsection to determine a strat-
egy not later than 60 days after any such assess-
ment is submitted or, in the case of an assessment 
submitted under subsection (g)(2)(D), not later than 
30 days after such assessment is submitted. 
‘‘(3) ACTION.— 
‘‘(A) IN
GENERAL.—Unless the dispute 
resolution process described under paragraph 
(4) or (5) applies, the Secretary, in consultation 
with the offices described in subsection (c)(2), 
shall describe any required risk evaluation and
303 
mitigation strategy for a drug, or any modifica-
tion to any required strategy— 
‘‘(i) as part of the action letter on the 
application, when a proposed strategy is 
submitted under subsection (a) or a modi-
fication to the strategy is proposed as part 
of an assessment of the strategy submitted 
under subsection (g)(1); or 
‘‘(ii) in an order issued not later than 
90 days after the date discussions of such 
modification begin under paragraph (2), 
when a modification to the strategy is pro-
posed as part of an assessment of the 
strategy submitted under subsection (g)(1) 
or under any of subparagraphs (B) 
through (D) of subsection (g)(2). 
‘‘(B) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
fails to act as provided under subparagraph 
(A). 
‘‘(C) PUBLIC
AVAILABILITY.—Any action 
letter described in subparagraph (A)(i) or order 
described in subparagraph (A)(ii) shall be made 
publicly available.
304 
‘‘(4) DISPUTE
RESOLUTION
AT
INITIAL
AP-
PROVAL.—If a proposed risk evaluation and mitiga-
tion strategy is submitted under subsection (a)(1) in 
an application for initial approval of a drug and 
there is a dispute about the strategy, the responsible 
person shall use the major dispute resolution proce-
dures as set forth in the letters described in section 
101(c) of the Food and Drug Administration 
Amendments Act of 2007. 
‘‘(5) DISPUTE
RESOLUTION
IN
ALL
OTHER 
CASES.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 
15 days, and not later than 35 days, after 
discussions under paragraph (2) have 
begun, the responsible person may request 
in writing that a dispute about the strat-
egy be reviewed by the Drug Safety Over-
sight Board under subsection (j), except 
that the determination of the Secretary to 
require a risk evaluation and mitigation 
strategy is not subject to review under this 
paragraph. The preceding sentence does 
not prohibit review under this paragraph of 
the particular elements of such a strategy.
305 
‘‘(ii) SCHEDULING.—Upon receipt of 
a request under clause (i), the Secretary 
shall schedule the dispute involved for re-
view under subparagraph (B) and, not 
later than 5 business days of scheduling 
the dispute for review, shall publish by 
posting on the Internet or otherwise a no-
tice that the dispute will be reviewed by 
the Drug Safety Oversight Board. 
‘‘(B) SCHEDULING REVIEW.—If a respon-
sible person requests review under subpara-
graph (A), the Secretary— 
‘‘(i) shall schedule the dispute for re-
view at 1 of the next 2 regular meetings of 
the Drug Safety Oversight Board, which-
ever meeting date is more practicable; or 
‘‘(ii) may convene a special meeting of 
the Drug Safety Oversight Board to review 
the matter more promptly, including to 
meet an action deadline on an application 
(including a supplemental application). 
‘‘(C) AGREEMENT AFTER DISCUSSION OR 
ADMINISTRATIVE APPEALS.— 
‘‘(i) FURTHER DISCUSSION OR ADMIN-
ISTRATIVE APPEALS.—A request for review
308 
‘‘(F) 
RECOMMENDATION
OF
THE 
BOARD.—Not later than 5 days after any such 
meeting, the Drug Safety Oversight Board shall 
provide a written recommendation on resolving 
the dispute to the Secretary. Not later than 5 
days after the Board provides such written rec-
ommendation to the Secretary, the Secretary 
shall make the recommendation available to the 
public. 
‘‘(G) ACTION BY THE SECRETARY.— 
‘‘(i) ACTION
LETTER.—With respect 
to a proposal or assessment referred to in 
paragraph (1), the Secretary shall issue an 
action letter that resolves the dispute not 
later than the later of— 
‘‘(I) the action deadline for the 
action letter on the application; or 
‘‘(II) 7 days after receiving the 
recommendation of the Drug Safety 
Oversight Board. 
‘‘(ii) ORDER.—With respect to an as-
sessment of an approved risk evaluation 
and mitigation strategy under subsection 
(g)(1) or under any of subparagraphs (B) 
through (D) of subsection (g)(2), the Sec-
309 
retary shall issue an order, which shall be 
made public, that resolves the dispute not 
later than 7 days after receiving the rec-
ommendation of the Drug Safety Oversight 
Board. 
‘‘(H) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
fails to act as provided for under subparagraph 
(G). 
‘‘(I) EFFECT
ON
ACTION
DEADLINE.— 
With respect to a proposal or assessment re-
ferred to in paragraph (1), the Secretary shall 
be considered to have met the action deadline 
for the action letter on the application if the re-
sponsible person requests the dispute resolution 
process described in this paragraph and if the 
Secretary— 
‘‘(i) has initiated the discussions de-
scribed under paragraph (2) not less than 
60 days before such action deadline; and 
‘‘(ii) has complied with the timing re-
quirements of scheduling review by the 
Drug Safety Oversight Board, providing a 
written recommendation, and issuing an
310 
action letter under subparagraphs (B), 
(F), and (G), respectively. 
‘‘(J) DISQUALIFICATION.—No individual 
who is an employee of the Food and Drug Ad-
ministration and who reviews a drug or who 
participated in an administrative appeal under 
subparagraph (C)(i) with respect to such drug 
may serve on the Drug Safety Oversight Board 
at a meeting under subparagraph (D) to review 
a dispute about the risk evaluation and mitiga-
tion strategy for such drug. 
‘‘(K) ADDITIONAL EXPERTISE.—The Drug 
Safety Oversight Board may add members with 
relevant expertise from the Food and Drug Ad-
ministration, including the Office of Pediatrics, 
the Office of Women’s Health, or the Office of 
Rare Diseases, or from other Federal public 
health or health care agencies, for a meeting 
under subparagraph (D) of the Drug Safety 
Oversight Board. 
‘‘(6) USE
OF
ADVISORY
COMMITTEES.—The 
Secretary may convene a meeting of 1 or more advi-
sory committees of the Food and Drug Administra-
tion to—
311 
‘‘(A) review a concern about the safety of 
a drug or class of drugs, including before an as-
sessment of the risk evaluation and mitigation 
strategy or strategies of such drug or drugs is 
required to be submitted under any of subpara-
graphs (B) through (D) of subsection (g)(2); 
‘‘(B) review the risk evaluation and mitiga-
tion strategy or strategies of a drug or group 
of drugs; or 
‘‘(C) review a dispute under paragraph (4) 
or (5). 
‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS 
EFFECTS.— 
‘‘(A) IN GENERAL.—When a concern about 
a serious risk of a drug may be related to the 
pharmacological class of the drug, the Sec-
retary, in consultation with the offices described 
in subsection (c)(2), may defer assessments of 
the approved risk evaluation and mitigation 
strategies for such drugs until the Secretary 
has convened 1 or more public meetings to con-
sider possible responses to such concern. 
‘‘(B) NOTICE.—If the Secretary defers an 
assessment under subparagraph (A), the Sec-
retary shall—
312 
‘‘(i) give notice of the deferral to the 
holder of the approved covered application 
not later than 5 days after the deferral; 
‘‘(ii) publish the deferral in the Fed-
eral Register; and 
‘‘(iii) give notice to the public of any 
public meetings to be convened under sub-
paragraph (A), including a description of 
the deferral. 
‘‘(C) PUBLIC
MEETINGS.—Such public 
meetings may include— 
‘‘(i) 1 or more meetings of the respon-
sible person for such drugs; 
‘‘(ii) 1 or more meetings of 1 or more 
advisory committees of the Food and Drug 
Administration, as provided for under 
paragraph (6); or 
‘‘(iii) 1 or more workshops of sci-
entific experts and other stakeholders. 
‘‘(D) ACTION.—After considering the dis-
cussions from any meetings under subpara-
graph (A), the Secretary may— 
‘‘(i) announce in the Federal Register 
a planned regulatory action, including a 
modification to each risk evaluation and
315 
new drug application, and the holder of the 
reference drug product; or 
‘‘(ii) an aspect of the elements to as-
sure safe use for the applicable listed drug 
is claimed by a patent that has not expired 
or is a method or process that, as a trade 
secret, is entitled to protection, and the ap-
plicant for the abbreviated new drug appli-
cation certifies that it has sought a license 
for use of an aspect of the elements to as-
sure safe use for the applicable listed drug 
and that it was unable to obtain a license. 
A certification under clause (ii) shall include a 
description of the efforts made by the applicant 
for the abbreviated new drug application to ob-
tain a license. In a case described in clause (ii), 
the Secretary may seek to negotiate a voluntary 
agreement with the owner of the patent, meth-
od, or process for a license under which the ap-
plicant for such abbreviated new drug applica-
tion may use an aspect of the elements to as-
sure safe use, if required under subsection (f) 
for the applicable listed drug, that is claimed by 
a patent that has not expired or is a method or
316 
process that as a trade secret is entitled to pro-
tection. 
‘‘(2) ACTION BY SECRETARY.—For an applica-
ble listed drug for which a drug is approved under 
section 505(j), the Secretary— 
‘‘(A) shall undertake any communication 
plan to health care providers required under 
subsection (e)(3) for the applicable listed drug; 
and 
‘‘(B) shall inform the responsible person 
for the drug that is so approved if the risk eval-
uation and mitigation strategy for the applica-
ble listed drug is modified. 
‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— 
‘‘(1) IN
GENERAL.—There is established a 
Drug Safety Oversight Board. 
‘‘(2) COMPOSITION; 
MEETINGS.—The Drug 
Safety Oversight Board shall— 
‘‘(A) be composed of scientists and health 
care practitioners appointed by the Secretary, 
each of whom is an employee of the Federal 
Government; 
‘‘(B) include representatives from offices 
throughout the Food and Drug Administration,
317 
including the offices responsible for post-
approval safety of drugs; 
‘‘(C) include at least 1 representative each 
from the National Institutes of Health and the 
Department of Health and Human Services 
(other than the Food and Drug Administra-
tion); 
‘‘(D) include such representatives as the 
Secretary shall designate from other appro-
priate agencies that wish to provide representa-
tives; and 
‘‘(E) meet at least monthly to provide 
oversight and advice to the Secretary on the 
management of important drug safety issues.’’. 
(c) REGULATION OF BIOLOGICAL PRODUCTS.—Sec-
tion 351 of the Public Health Service Act (42 U.S.C. 262) 
is amended— 
(1) in subsection (a)(2), by adding at the end 
the following: 
‘‘(D) POSTMARKET STUDIES AND CLINICAL TRIALS; 
LABELING; RISK EVALUATION AND MITIGATION STRAT-
EGY.—A person that submits an application for a license 
under this paragraph is subject to sections 505(o), 505(p), 
and 505–1 of the Federal Food, Drug, and Cosmetic 
Act.’’; and
318 
(2) in subsection (j), by inserting ‘‘, including 
the requirements under sections 505(o), 505(p), and 
505–1 of such Act,’’ after ‘‘, and Cosmetic Act’’. 
(d) ADVERTISEMENTS
OF
DRUGS.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
as amended by section 801(b), is amended— 
(1) in section 301 (21 U.S.C. 331), by adding 
at the end the following: 
‘‘(kk) The dissemination of a television advertisement 
without complying with section 503B.’’; and 
(2) by inserting after section 503A the fol-
lowing: 
‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS. 
‘‘(a) IN GENERAL.—The Secretary may require the 
submission of any television advertisement for a drug (in-
cluding any script, story board, rough, or a completed 
video production of the television advertisement) to the 
Secretary for review under this section not later than 45 
days before dissemination of the television advertisement. 
‘‘(b) REVIEW.—In conducting a review of a television 
advertisement under this section, the Secretary may make 
recommendations with respect to information included in 
the label of the drug— 
‘‘(1) on changes that are—
319 
‘‘(A) necessary to protect the consumer 
good and well-being; or 
‘‘(B) consistent with prescribing informa-
tion for the product under review; and 
‘‘(2) if appropriate and if information exists, on 
statements for inclusion in the advertisement to ad-
dress the specific efficacy of the drug as it relates 
to specific population groups, including elderly popu-
lations, children, and racial and ethnic minorities. 
‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Ex-
cept as provided by subsection (e), this section does not 
authorize the Secretary to make or direct changes in any 
material submitted pursuant to subsection (a). 
‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY 
AND ETHNICALLY DIVERSE COMMUNITIES.—In formu-
lating recommendations under subsection (b), the Sec-
retary shall take into consideration the impact of the ad-
vertised drug on elderly populations, children, and racially 
and ethnically diverse communities. 
‘‘(e) SPECIFIC DISCLOSURES.— 
‘‘(1) SERIOUS
RISK; SAFETY
PROTOCOL.—In 
conducting a review of a television advertisement 
under this section, if the Secretary determines that 
the advertisement would be false or misleading with-
out a specific disclosure about a serious risk listed
320 
in the labeling of the drug involved, the Secretary 
may require inclusion of such disclosure in the ad-
vertisement. 
‘‘(2) DATE OF APPROVAL.—In conducting a re-
view of a television advertisement under this section, 
the Secretary may require the advertisement to in-
clude, for a period not to exceed 2 years from the 
date of the approval of the drug under section 505 
or section 351 of the Public Health Service Act, a 
specific disclosure of such date of approval if the 
Secretary determines that the advertisement would 
otherwise be false or misleading. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion may be construed as having any effect on require-
ments under section 502(n) or on the authority of the Sec-
retary under section 314.550, 314.640, 601.45, or 601.94 
of title 21, Code of Federal Regulations (or successor reg-
ulations).’’. 
(3) DIRECT-TO-CONSUMER ADVERTISEMENTS.— 
(A) IN GENERAL.—Section 502(n) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(n)) is amended by adding at the 
end the following: ‘‘In the case of an advertise-
ment for a drug subject to section 503(b)(1) 
presented directly to consumers in television or
326 
beginning on the date the order making such assessments 
was issued. 
‘‘(7) If any person fails to pay an assessment of a 
civil penalty under paragraph (1)— 
‘‘(A) after the order making the assessment be-
comes final, and if such person does not file a peti-
tion for judicial review of the order in accordance 
with paragraph (6), or 
‘‘(B) after a court in an action brought under 
paragraph (6) has entered a final judgment in favor 
of the Secretary, 
the Attorney General of the United States shall recover 
the amount assessed (plus interest at currently prevailing 
rates from the date of the expiration of the 60-day period 
referred to in paragraph (6) or the date of such final judg-
ment, as the case may be) in an action brought in any 
appropriate district court of the United States. In such 
an action, the validity, amount, and appropriateness of 
such penalty shall not be subject to review.’’. 
(5) REPORT ON DIRECT-TO-CONSUMER ADVER-
TISING.—Not later than 24 months after the date of 
the enactment of this Act, the Secretary of Health 
and Human Services shall report to the Congress on 
direct-to-consumer advertising and its ability to com-
municate to subsets of the general population, in-
327 
cluding elderly populations, children, and racial and 
ethnic minority communities. The Secretary shall 
utilize the Advisory Committee on Risk Communica-
tion established under this Act to advise the Sec-
retary with respect to such report. The Advisory 
Committee shall study direct-to-consumer adver-
tising as it relates to increased access to health in-
formation and decreased health disparities for these 
populations. The report required by this paragraph 
shall recommend effective ways to present and dis-
seminate information to these populations. Such re-
port shall also make recommendations regarding im-
pediments to the participation of elderly populations, 
children, racially and ethnically diverse communities, 
and medically underserved populations in clinical 
drug trials and shall recommend best practice ap-
proaches for increasing the inclusion of such subsets 
of the general population. The Secretary of Health 
and Human Services shall submit the report under 
this paragraph to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House 
of Representatives. 
(6) RULEMAKING.—Section 502(n) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
328 
352(n)) is amended by striking ‘‘the procedure spec-
ified in section 701(e) of this Act’’ and inserting 
‘‘section 701(a)’’. 
(e) RULE OF CONSTRUCTION REGARDING PEDIATRIC 
STUDIES.—This title and the amendments made by this 
title may not be construed as affecting the authority of 
the Secretary of Health and Human Services to request 
pediatric studies under section 505A of the Federal Food, 
Drug, and Cosmetic Act or to require such studies under 
section 505B of such Act. 
SEC. 902. ENFORCEMENT. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(y) If it is a drug subject to an approved risk evalua-
tion and mitigation strategy pursuant to section 505(p) 
and the responsible person (as such term is used in section 
505–1) fails to comply with a requirement of such strategy 
provided for under subsection (d), (e), or (f) of section 
505–1. 
‘‘(z) If it is a drug, and the responsible person (as 
such term is used in section 505(o)) is in violation of a 
requirement established under paragraph (3) (relating to 
postmarket studies and clinical trials) or paragraph (4)
329 
(relating to labeling) of section 505(o) with respect to such 
drug.’’. 
(b) CIVIL PENALTIES.—Section 303(f) of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 
801(b), is amended— 
(1) by inserting after paragraph (3), as added 
by section 801(b)(2), the following: 
‘‘(4)(A) Any responsible person (as such term is used 
in section 505–1) that violates a requirement of section 
505(o), 505(p), or 505–1 shall be subject to a civil mone-
tary penalty of— 
‘‘(i) not more than $250,000 per violation, and 
not to exceed $1,000,000 for all such violations ad-
judicated in a single proceeding; or 
‘‘(ii) in the case of a violation that continues 
after the Secretary provides written notice to the re-
sponsible person, the responsible person shall be sub-
ject to a civil monetary penalty of $250,000 for the 
first 30-day period (or any portion thereof) that the 
responsible person continues to be in violation, and 
such amount shall double for every 30-day period 
thereafter that the violation continues, not to exceed 
$1,000,000 for any 30-day period, and not to exceed 
$10,000,000 for all such violations adjudicated in a 
single proceeding.
330 
‘‘(B) In determining the amount of a civil penalty 
under subparagraph (A)(ii), the Secretary shall take into 
consideration whether the responsible person is making ef-
forts toward correcting the violation of the requirement 
of section 505(o), 505(p), or 505–1 for which the respon-
sible person is subject to such civil penalty.’’; and 
(2) in paragraph (5), as redesignated by section 
801(b)(2)(A), by striking ‘‘paragraph (1), (2), or 
(3)’’ each place it appears and inserting ‘‘paragraph 
(1), (2), (3), or (4)’’. 
SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF 
APPROVAL. 
Section 505(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(e)) is amended by adding at 
the end the following: ‘‘The Secretary may withdraw the 
approval of an application submitted under this section, 
or suspend the approval of such an application, as pro-
vided under this subsection, without first ordering the ap-
plicant to submit an assessment of the approved risk eval-
uation and mitigation strategy for the drug under section 
505–1(g)(2)(D).’’. 
SEC. 904. BENEFIT-RISK ASSESSMENTS. 
Not later than 1 year after the date of the enactment 
of this Act, the Commissioner of Food and Drugs shall 
submit to the Congress a report on how best to commu-
331 
nicate to the public the risks and benefits of new drugs 
and the role of the risk evaluation and mitigation strategy 
in assessing such risks and benefits. As part of such study, 
the Commissioner may consider the possibility of including 
in the labeling and any direct-to-consumer advertisements 
of a newly approved drug or indication a unique symbol 
indicating the newly approved status of the drug or indica-
tion for a period after approval. 
SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND 
ANALYSIS. 
(a) IN GENERAL.—Subsection (k) of section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following: 
‘‘(3) ACTIVE
POSTMARKET
RISK
IDENTIFICA-
TION.— 
‘‘(A) DEFINITION.—In this paragraph, the 
term ‘data’ refers to information with respect to 
a drug approved under this section or under 
section 351 of the Public Health Service Act, 
including claims data, patient survey data, 
standardized analytic files that allow for the 
pooling and analysis of data from disparate 
data environments, and any other data deemed 
appropriate by the Secretary.
353 
SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS 
OR 
BIOLOGICAL 
PRODUCTS 
HAVE 
BEEN 
ADDED. 
(a) PROHIBITION.—Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by 
section 901(d), is amended by adding at the end the fol-
lowing: 
‘‘(ll) The introduction or delivery for introduction 
into interstate commerce of any food to which has been 
added a drug approved under section 505, a biological 
product licensed under section 351 of the Public Health 
Service Act, or a drug or a biological product for which 
substantial clinical investigations have been instituted and 
for which the existence of such investigations has been 
made public, unless— 
‘‘(1) such drug or such biological product was 
marketed in food before any approval of the drug 
under section 505, before licensure of the biological 
product under such section 351, and before any sub-
stantial clinical investigations involving the drug or 
the biological product have been instituted; 
‘‘(2) the Secretary, in the Secretary’s discre-
tion, has issued a regulation, after notice and com-
ment, approving the use of such drug or such bio-
logical product in the food;