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— 
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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— 
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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-
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