267 
ment process and the process for the review of 
human drug applications); 
‘‘(B) if the assessment is submitted under 
subparagraph (B) or (C) or subsection (g)(2), 
not later than 20 days after such submission; 
‘‘(C) if the assessment is submitted under 
subsection (g)(1) or subsection (g)(2)(D) , not 
later than 30 days after such submission; or 
‘‘(D) if the assessment is submitted under 
subsection (g)(2)(D), not later than 10 days 
after such submission. 
‘‘(4) ACTION.— 
‘‘(A) IN GENERAL.—Unless the responsible 
person requests the dispute resolution process 
described under paragraph (5), the Secretary 
shall approve and describe the risk evaluation 
and mitigation strategy for a drug, or any 
modification to the strategy— 
‘‘(i) as part of the action letter on the 
application, when a proposed strategy is 
submitted under subsection (a) or an as-
sessment of the strategy is submitted 
under subsection (g)(1); or 
‘‘(ii) in an order issued not later than 
50 days after the date discussions of such
268 
modification begin under paragraph (3), 
when an assessment of the strategy is sub-
mitted 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. 
‘‘(5) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 
15 days, and not later than 35 days, after 
discussions under paragraph (3) 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
269 
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. 
‘‘(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).
270 
‘‘(C) AGREEMENT AFTER DISCUSSION OR 
ADMINISTRATIVE APPEALS.— 
‘‘(i) FURTHER DISCUSSION OR ADMIN-
ISTRATIVE APPEALS.—A request for review 
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 letters of the Sec-
retary (relating to the use of fees collected 
under section 736 to expedite the drug de-
velopment process and the process for the 
review of human drug applications) for 
procedural or scientific matters involving 
the review of human drug applications and 
supplemental applications that cannot be 
resolved at the divisional level. 
‘‘(ii) AGREEMENT
TERMINATES
DIS-
PUTE RESOLUTION.—At any time before a 
decision and order is issued under sub-
paragraph (G) , the Secretary and the re-
sponsible person may reach an agreement
271 
on the risk evaluation and mitigation strat-
egy through further discussion or adminis-
trative appeals, terminating the dispute 
resolution process, and the Secretary shall 
issue an action letter or order, as appro-
priate, 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; 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 30 days of the meeting. The 
Secretary shall redact the transcript to protect 
any trade secrets or other confidential informa-
tion described in section 552(b)(4) of title 5, 
United States Code. 
‘‘(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
272 
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 referred 
to in paragraph (3)(A); 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-
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.
273 
‘‘(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 
referred to in paragraph (3)(A) with respect to 
the application involved if the responsible per-
son requests the dispute resolution process de-
scribed in this paragraph and if the Secretary— 
‘‘(i) has initiated the discussions de-
scribed under paragraph (3) 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 
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
274 
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— 
‘‘(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);
275 
‘‘(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 (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 Secretary 
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 consider possible re-
sponses to such concern. If the Secretary defers 
an assessment under this subparagraph, the 
Secretary shall give notice to the public of the 
deferral not later than 5 days of the deferral. 
‘‘(B) PUBLIC
MEETINGS.—Such public 
meetings may include— 
‘‘(i) 1 or more meetings of the re-
viewed entities 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
276 
‘‘(iii) 1 or more workshops of sci-
entific experts and other stakeholders. 
‘‘(C) ACTION.—After considering the dis-
cussions from any meetings under subpara-
graph (B), the Secretary may— 
‘‘(i) announce in the Federal Register 
a planned regulatory action, including a 
modification to each risk evaluation and 
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 may coordinate the timetable for submis-
sion 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 ap-
proval and risk management processes of the United 
States. If the Secretary takes action to coordinate
277 
such timetable, the Secretary shall give notice to the 
public of the action not later than 5 days after the 
action. 
‘‘(9) EFFECT.—Use of the processes described 
in paragraphs (7) and (8) shall not delay action on 
an application or a supplement to an application for 
a drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
‘‘(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) Restrictions on distribution or use, if 
required under subsection (f) for the listed 
drug. A drug that is the subject of an abbre-
viated new drug application and the listed drug 
shall use a single, shared system under sub-
section (f)(4). The Secretary may waive the re-
quirement under the preceding sentence for a 
drug that is the subject of an abbreviated new
278 
drug application if the Secretary determines 
that— 
‘‘(i) it is not practical for the drug to 
use such single, shared system; or 
‘‘(ii) the burden of using the single, 
shared system outweighs the benefit of 
using the single system. 
‘‘(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,
279 
each of whom is an employee of the Federal 
Government; 
‘‘(B) include representatives from offices 
throughout the Food and Drug Administration; 
‘‘(C) include at least 1 representative from 
each of 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) RISK EVALUATION AND MITIGATION STRAT-
EGY.—A person that submits an application for a license 
under this paragraph is subject to section 505(p) of the 
Federal Food, Drug, and Cosmetic Act.’’; and
280 
(2) in subsection (j), by inserting ‘‘, including 
the requirements under section 505(p) of such Act,’’ 
after ‘‘, and Cosmetic Act’’. 
(d) PREREVIEW OF ADVERTISEMENTS.— 
(1) SENSE OF CONGRESS.—It is the sense of 
the Congress that— 
(A) ‘‘Guidance for Industry Consumer-Di-
rected Broadcast Advertisements’’ issued by the 
Food and Drug Administration in August, 
1999, represents generally good guidance for di-
rect-to-consumer (DTC) advertising of prescrip-
tion medicines and other treatments; 
(B) direct-to-consumer advertising as an 
accurate source of health information for all 
populations, specifically including the elderly 
populations, children, chronically ill and racial 
and ethnic minority populations, should be 
made more reliable by ensuring the truth and 
credibility of information provided through such 
advertising; and 
(C) the Congress will work with the Food 
and Drug Administration to ensure that infor-
mation provided through direct-to-consumer ad-
vertising of prescription medicines and other 
treatments is not false or misleading and com-
281 
municates clearly and sensitively to all commu-
nities. 
(2) PREREVIEW.—The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) is amend-
ed— 
(A) in section 301 (21 U.S.C. 331), by 
adding at the end the following: 
‘‘(jj) The dissemination of a television advertisement 
without complying with section 503B.’’; and 
(B) 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— 
‘‘(1) on changes that are— 
‘‘(A) necessary to protect the consumer 
good and well-being; or
282 
‘‘(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 a specific population group, including elderly pop-
ulations, children, and racially and ethnically diverse 
populations. 
‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—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 
in the labeling of the drug involved, the Secretary