SEC. 2. AMENDING OR REPEALING MONOGRAPHS. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 568. AMENDING OR REPEALING MONOGRAPHS. 
‘‘(a) GOOD CAUSE.—In applying section 553 of title 
5, United States Code, to any amendment to or repeal 
of a monograph established pursuant to section 330.10 of 
title 21, Code of Federal Regulations (or any successor 
regulation), good cause (as such term is used in sub-
sections (b) and (d) of such section 553) is deemed to 
exist, and notice and public procedure are deemed to be 
unnecessary (as such term is used in subsection (b) of 
such section 553), for purposes of making such amend-
ment or repeal if— 
‘‘(1) there is a finding— 
‘‘(A) by the Secretary that the category of 
drugs or the specific drug involved is associated 
with a significant risk; or 
‘‘(B) by the Secretary, after holding a 
meeting of an advisory committee of the Food 
and Drug Administration to evaluate the cat-
egory of drugs or the specific drug involved, 
that such category of drugs or specific drug 
lacks evidence of effectiveness; and 
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‘‘(2) such amendment or repeal is based, in 
whole or in part, on such finding. 
‘‘(b) SUBSEQUENT COMMENT PERIOD.—After the 
amendment or repeal of a monograph in accordance with 
subsection (a), the Secretary may provide a period for 
public comments on the amendment or repeal and may 
make additional changes with respect to the monograph 
to reflect comments received, if determined appropriate by 
the Secretary.’’. 
SEC. 3. EXPANSION OF FDA’S AUTHORITY TO REGULATE 
DRUG ADVERTISING. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended— 
(1) in section 303(g)(1), by striking ‘‘With re-
spect to’’ and all that follows through ‘‘section 351 
of the Public Health Service Act,’’ and inserting 
‘‘With respect to a person who is a holder of an ap-
proved application under section 505 or under sec-
tion 351 of the Public Health Service Act, or a per-
son who is the manufacturer of a drug marketed 
pursuant to a monograph established pursuant to 
section 330.10 of title 21, Code of Federal Regula-
tions (or any successor regulation),’’; and 
(2) in section 502(n)— 
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(A) by striking the term ‘‘prescription 
drug’’ each place such term appears and insert-
ing ‘‘drug’’; and 
(B) 
by 
striking 
‘‘subject 
to 
section 
503(b)(1)’’. 
(b) REGULATIONS.—The Commissioner of Food and 
Drugs shall promulgate such revisions to the regulations 
under section 502(n) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(n)) as may be necessary to carry 
out the amendments made by subsection (a). 
(c) TRANSITIONAL PROVISIONS.— 
(1) 
FALSE
OR
MISLEADING
ADVERTISE-
MENTS.—During the period beginning on the date of 
the enactment of this Act and ending on the effec-
tive date of the regulations required by subsection 
(b), a drug other than a prescription drug is deemed 
to be misbranded under section 502(n) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
352(n)) if any advertisement or other descriptive 
printed matter issued or caused to be issued by the 
manufacturer, packer, or distributer with respect to 
that drug is false or misleading. 
(2) DEFINITIONS.—The terms used in this sub-
section have the meanings applicable to those terms 
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in section 502(n) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352(n)). 
SEC. 4. IDENTIFICATION AND REPORT ON MONOGRAPHS. 
(a) IDENTIFICATION.— 
(1) IN GENERAL.—The Commissioner of Food 
and Drugs (in this section referred to as the ‘‘Com-
missioner’’) shall identify each monograph estab-
lished pursuant to section 330.10 of title 21, Code 
of Federal Regulations, that may require further re-
view to determine whether the monograph is in need 
of amendment or repeal. 
(2) PUBLIC COMMENTS.—To assist in the iden-
tification of such monographs, the Commissioner 
shall give interested persons, including medical soci-
eties and other entities with expertise on drugs, an 
opportunity to submit comments. 
(b) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the Commissioner shall sub-
mit a report to the Congress identifying any monographs 
that, as determined by the Commissioner, may require fur-
ther review to determine whether such monographs are in 
need of amendment or repeal. Such report shall include— 
(1) an assessment of the resources necessary to 
conduct such review and make such amendments or 
repeals; 
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(2) a summary of the comments received under 
subsection (a)(2); and 
(3) a listing of the monographs that, as rec-
ommended in such comments, are in need of amend-
ment or repeal and the basis for such recommenda-
tions. 
SEC. 5. AUTHORIZATION OF APPROPRIATIONS. 
To carry out this Act and the amendments made by 
this Act, there are authorized to be appropriated such 
sums as may be necessary. 
Æ 
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