273 
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 
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00273
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
274 
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); 
‘‘(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00274
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
275 
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 
‘‘(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00275
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
276 
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 
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.— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00276
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
277 
‘‘(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 
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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00277
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
278 
‘‘(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; 
‘‘(C) include at least 1 representative from 
each of the National Institutes of Health and 
the Department of Health and Human Services 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00278
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
279 
(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 
(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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00279
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
280 
(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-
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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00280
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
281 
(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 
‘‘(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00281
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
282 
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 
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00282
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
283 
date of the approval of the drug under section 505, 
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 the author-
ity of the Secretary under section 314.550, 314.640, 
601.45, or 601.94 of title 21, Code of Federal Regulations 
(or successor regulations).’’. 
(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 
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 and conspicuous 
manner.’’. 
(B) REGULATIONS TO DETERMINE CLEAR 
AND CONSPICUOUS MANNER.—The Secretary of 
Health and Human Services shall by regulation 
establish standards for determining whether a 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00283
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS