[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4083 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 4083

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
    amendment or repeal of monographs, to expand the Food and Drug 
Administration's authority to regulate drug advertising, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 6, 2007

 Mr. Waxman (for himself and Mr. Allen) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
    amendment or repeal of monographs, to expand the Food and Drug 
Administration's authority to regulate drug advertising, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Non-Prescription Drug Modernization 
Act of 2007''.

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 
subsections (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 amendment 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 category of drugs or the 
                specific drug involved, that such category of drugs or 
                specific drug lacks evidence of effectiveness; and
            ``(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 respect 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 approved application under section 505 or under 
        section 351 of the Public Health Service Act, or a person who 
        is the manufacturer of a drug marketed pursuant to a monograph 
        established pursuant to section 330.10 of title 21, Code of 
        Federal Regulations (or any successor regulation),''; and
            (2) in section 502(n)--
                    (A) by striking the term ``prescription drug'' each 
                place such term appears and inserting ``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 Cosmetic 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 advertisements.--During the period 
        beginning on the date of the enactment of this Act and ending 
        on the effective 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 Federal 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 subsection have 
        the meanings applicable to those terms 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 ``Commissioner'') shall 
        identify each monograph established pursuant to section 330.10 
        of title 21, Code of Federal Regulations, that may require 
        further review to determine whether the monograph is in need of 
        amendment or repeal.
            (2) Public comments.--To assist in the identification of 
        such monographs, the Commissioner shall give interested 
        persons, including medical societies 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 submit a report to the Congress 
identifying any monographs that, as determined by the Commissioner, may 
require further 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;
            (2) a summary of the comments received under subsection 
        (a)(2); and
            (3) a listing of the monographs that, as recommended in 
        such comments, are in need of amendment or repeal and the basis 
        for such recommendations.

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.
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