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; 
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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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296 
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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298 
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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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 
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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. 
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‘‘(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 
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under subparagraph (A) shall not preclude 
further discussions to reach agreement on 
the risk evaluation and mitigation strategy, 
and such a request shall not preclude the 
use of administrative appeals within the 
Food and Drug Administration to reach 
agreement on the strategy, including ap-
peals as described in the letters described 
in section 101(c) of the Food and Drug 
Administration Amendments Act of 2007 
for procedural or scientific matters involv-
ing the review of human drug applications 
and supplemental applications that cannot 
be resolved at the divisional level. At the 
time a review has been scheduled under 
subparagraph (B) and notice of such re-
view has been posted, the responsible per-
son shall either withdraw the request 
under subparagraph (A) or terminate the 
use of such administrative appeals. 
‘‘(ii) AGREEMENT
TERMINATES
DIS-
PUTE RESOLUTION.—At any time before a 
decision and order is issued under sub-
paragraph (G) , the Secretary (in consulta-
tion with the offices described in sub-
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section (c)(2)) and the responsible person 
may reach an agreement on the risk eval-
uation and mitigation strategy through 
further discussion or administrative ap-
peals, terminating the dispute resolution 
process, and the Secretary shall issue an 
action letter or order, as appropriate, that 
describes the strategy. 
‘‘(D) MEETING
OF
THE
BOARD.—At a 
meeting of the Drug Safety Oversight Board 
described in subparagraph (B), the Board 
shall— 
‘‘(i) hear from both parties via written 
or oral presentation; and 
‘‘(ii) review the dispute. 
‘‘(E) RECORD
OF
PROCEEDINGS.—The 
Secretary shall ensure that the proceedings of 
any such meeting are recorded, transcribed, and 
made public within 90 days of the meeting. The 
Secretary shall redact the transcript to protect 
any trade secrets and other information that is 
exempted from disclosure under section 552 of 
title 5, United States Code, or section 552a of 
title 5, United States Code. 
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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-
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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 
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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— 
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‘‘(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— 
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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 
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313 
mitigation strategy, for drugs in the phar-
macological class; 
‘‘(ii) seek public comment about such 
action; and 
‘‘(iii) after seeking such comment, 
issue an order addressing such regulatory 
action. 
‘‘(8) 
INTERNATIONAL
COORDINATION.—The 
Secretary, in consultation with the offices described 
in subsection (c)(2), may coordinate the timetable 
for submission of assessments under subsection (d), 
or a study or clinical trial under section 505(o)(3), 
with efforts to identify and assess the serious risks 
of such drug by the marketing authorities of other 
countries whose drug approval and risk management 
processes the Secretary deems comparable to the 
drug approval and risk management processes of the 
United States. If the Secretary takes action to co-
ordinate such timetable, the Secretary shall give no-
tice to the responsible person. 
‘‘(9) EFFECT.—Use of the processes described 
in paragraphs (7) and (8) shall not be the sole 
source of delay of action on an application or a sup-
plement to an application for a drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
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‘‘(1) IN GENERAL.—A drug that is the subject 
of an abbreviated new drug application under section 
505(j) is subject to only the following elements of 
the risk evaluation and mitigation strategy required 
under subsection (a) for the applicable listed drug: 
‘‘(A) A Medication Guide or patient pack-
age insert, if required under subsection (e) for 
the applicable listed drug. 
‘‘(B) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug. 
A drug that is the subject of an abbreviated 
new drug application and the listed drug shall 
use a single, shared system under subsection 
(f). The Secretary may waive the requirement 
under the preceding sentence for a drug that is 
the subject of an abbreviated new drug applica-
tion, and permit the applicant to use a dif-
ferent, comparable aspect of the elements to as-
sure safe use, if the Secretary determines 
that— 
‘‘(i) the burden of creating a single, 
shared system outweighs the benefit of a 
single, system, taking into consideration 
the impact on health care providers, pa-
tients, the applicant for the abbreviated 
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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 
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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 
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(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— 
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‘‘(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 
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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 
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radio format and stating the name of the drug 
and its conditions of use, the major statement 
relating to side effects and contraindications 
shall be presented in a clear, conspicuous, and 
neutral manner.’’. 
(B) REGULATIONS TO DETERMINE CLEAR, 
CONSPICUOUS, AND
NEUTRAL
MANNER.—Not 
later than 30 months after the date of the en-
actment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary of 
Health and Human Services shall by regulation 
establish standards for determining whether a 
major statement relating to side effects and 
contraindications of a drug, described in section 
502(n) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(n)) (as amended by 
subparagraph (A)) is presented in the manner 
required under such section. 
(4) CIVIL PENALTIES.—Section 303 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333), 
as amended by section 801(b), is amended by adding 
at the end the following: 
‘‘(g)(1) With respect to a person who is a holder of 
an approved application under section 505 for a drug sub-
ject to section 503(b) or under section 351 of the Public 
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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-
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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. 
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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) 
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(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. 
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‘‘(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-
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food after the responsible party has submitted a re-
port to the Food and Drug Administration under 
paragraph (1) with respect to such article of food— 
‘‘(A) the responsible party is not required 
to submit an additional report or make a notifi-
cation under paragraph (7); and 
‘‘(B) the responsible party shall amend the 
report submitted by the responsible party under 
paragraph (1) to include the data elements de-
scribed in paragraph (9), and, with respect to 
both such notification and such report, para-
graph (11) of subsection (e). 
‘‘(e) DATA ELEMENTS.—The data elements described 
in this subsection are the following: 
‘‘(1) The registration numbers of the respon-
sible party under section 415(a)(3). 
‘‘(2) The date on which an article of food was 
determined to be a reportable food. 
‘‘(3) A description of the article of food includ-
ing the quantity or amount. 
‘‘(4) The extent and nature of the adulteration. 
‘‘(5) If the adulteration of the article of food 
may have originated with the responsible party, the 
results of the investigation required under paragraph 
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mitted under subsection (b) for approval of 
the approved racemic drug; and 
‘‘(B) the application submitted under sub-
section (b) for such non-racemic drug is not 
submitted for approval of a condition of use— 
‘‘(i) in a therapeutic category in which 
the approved racemic drug has been ap-
proved; or 
‘‘(ii) for which any other enantiomer 
of the racemic drug has been approved. 
‘‘(2) LIMITATION.— 
‘‘(A) NO APPROVAL IN CERTAIN THERA-
PEUTIC CATEGORIES.—Until the date that is 10 
years after the date of approval of a non-race-
mic drug described in paragraph (1) and with 
respect to which the applicant has made the 
election provided for by such paragraph, the 
Secretary shall not approve such non-racemic 
drug for any condition of use in the therapeutic 
category in which the racemic drug has been 
approved. 
‘‘(B) LABELING.—If applicable, the label-
ing of a non-racemic drug described in para-
graph (1) and with respect to which the appli-
cant has made the election provided for by such 
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