<enum>I</enum><header>Labeling and advertising for prescription drugs</header> <section id="H1E0FEA79D63E4DD3A5601583A7208400"><enum>101.</enum><header>Advertising for prescription drugs</header> <subsection id="HE75D226D6B6446D5AB51ED999E6A1AA"><enum>(a)</enum><header>Advertisements intended for consumers; prior approval</header><text display-inline="yes-display-inline">Section 502(n) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352(n)</external-xref>) is amended by striking <quote>except that (A)</quote> and all that follows through <quote>and (B)</quote> and inserting the following: <quote>provided that (A)(i) in the case of an advertisement intended for consumers of a prescription drug, such regulations shall require prior approval by the Secretary of the content of the advertisement, which approval or denial shall be issued not later than 30 days after the content is submitted to the Secretary, and (ii) in the case of an advertisement not so intended, such regulations may not, except in extraordinary circumstances, require prior approval by the Secretary of the content of the advertisement, and (B)</quote>.</text></subsection> <subsection id="H3C8BBF6D30984AA4B8A662814CE531FB"><enum>(b)</enum><header>Two-year prohibition after approval of drug</header> <paragraph id="H2EE30FED8B704FDB9C116911E5D10095"><enum>(1)</enum><header>In general</header><text>Section 505(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(c)</external-xref>) is amended by adding at the end the following paragraph:</text> <quoted-block style="traditional" display-inline="no-display-inline" id="H293210BD9488427CA34C2EE097CA1C90"> <paragraph id="HB9A3AD9E5DDB4BB6A7571CDE4E55919C" indent="up1"><enum>(5)</enum> <subparagraph id="HE00F3B3B026E4B108FC2B86692319554" display-inline="yes-display-inline"><enum>(A)</enum><text>In the case of a prescription drug, the Secretary shall require as a condition of the approval of an application under subsection (b) that the applicant ensure that no advertisement for the drug is issued or caused to be issued during the two-year period beginning on the date on which the application is approved.</text></subparagraph> <subparagraph id="H59A5DA675507487BAC00245C59314DB6" indent="up1"><enum>(B)</enum><text>The Secretary, after notice and opportunity for a hearing, may extend the two-year period under subparagraph (A) if the Secretary determines that such extension is necessary to protect the public health.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HE8B1E42F0ED74876AFF3E0F37C48227D"><enum>(2)</enum><header>Enforcement</header><text>Section 502 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="traditional" display-inline="no-display-inline" id="H15163882D0F440FB9B00742600374039"> <paragraph id="H77D5F455EA414F1AA6468EF8D3579635" indent="up1"><enum>(x)</enum><text>If it is a prescription drug with respect to which there is a failure to comply with a requirement under section 505(c)(5).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HC926E659D5E94E5B94D33FE4DB5FBD3"><enum>(c)</enum><header>Rule of construction</header><text>The amendments made by subsections (a) and (b) may not be construed as affecting the authority of the Secretary of Health and Human Services under section 319 of the Public Health Service Act (relating to actions to respond to public health emergencies).</text></subsection></section> <section id="H0B881F23949D45CABCE707A4A567B7CA"><enum>102.</enum><header>Labeling and advertising for prescription drugs; report to Congress regarding comparative effectiveness and cost-effectiveness</header><text display-inline="no-display-inline">Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit to the Committee on Energy and Commerce in the House of Representatives, and the Committee on Health, Education, Labor, and Pensions in the Senate, a report providing a proposal for the inclusion in the labeling and advertisements for each prescription drug of information concerning the comparative effectiveness and comparative cost-effectiveness of the drug in relation to other prescription drugs that are in the same class of drugs. Such report shall include a description of the amendments to the Federal Food, Drug, and Cosmetic Act that would be necessary to enact such proposal.</text></section> <section id="H292A4955AA3C4C18B30007D758C70071"><enum>103.</enum><header>Funding for Division of Drug Marketing, Advertising, and Communications</header><text display-inline="no-display-inline">For carrying out the responsibilities of the Division of Drug Marketing, Advertising, and Communications (within the Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration), there are authorized to be appropriated $25,000,000 for fiscal year 2007, and such sums as may be necessary for each subsequent fiscal year.</text> </section>

109 HR 3696 IH: Medical Advertising Reform Act U.S. House of Representatives 2005-09-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

Short title

This Act may be cited as the

Medical Advertising Reform Act

<enum>I</enum><header>Labeling and advertising for prescription drugs</header> <section id="H1E0FEA79D63E4DD3A5601583A7208400"><enum>101.</enum><header>Advertising for prescription drugs</header> <subsection id="HE75D226D6B6446D5AB51ED999E6A1AA"><enum>(a)</enum><header>Advertisements intended for consumers; prior approval</header><text display-inline="yes-display-inline">Section 502(n) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352(n)</external-xref>) is amended by striking <quote>except that (A)</quote> and all that follows through <quote>and (B)</quote> and inserting the following: <quote>provided that (A)(i) in the case of an advertisement intended for consumers of a prescription drug, such regulations shall require prior approval by the Secretary of the content of the advertisement, which approval or denial shall be issued not later than 30 days after the content is submitted to the Secretary, and (ii) in the case of an advertisement not so intended, such regulations may not, except in extraordinary circumstances, require prior approval by the Secretary of the content of the advertisement, and (B)</quote>.</text></subsection> <subsection id="H3C8BBF6D30984AA4B8A662814CE531FB"><enum>(b)</enum><header>Two-year prohibition after approval of drug</header> <paragraph id="H2EE30FED8B704FDB9C116911E5D10095"><enum>(1)</enum><header>In general</header><text>Section 505(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(c)</external-xref>) is amended by adding at the end the following paragraph:</text> <quoted-block style="traditional" display-inline="no-display-inline" id="H293210BD9488427CA34C2EE097CA1C90"> <paragraph id="HB9A3AD9E5DDB4BB6A7571CDE4E55919C" indent="up1"><enum>(5)</enum> <subparagraph id="HE00F3B3B026E4B108FC2B86692319554" display-inline="yes-display-inline"><enum>(A)</enum><text>In the case of a prescription drug, the Secretary shall require as a condition of the approval of an application under subsection (b) that the applicant ensure that no advertisement for the drug is issued or caused to be issued during the two-year period beginning on the date on which the application is approved.</text></subparagraph> <subparagraph id="H59A5DA675507487BAC00245C59314DB6" indent="up1"><enum>(B)</enum><text>The Secretary, after notice and opportunity for a hearing, may extend the two-year period under subparagraph (A) if the Secretary determines that such extension is necessary to protect the public health.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HE8B1E42F0ED74876AFF3E0F37C48227D"><enum>(2)</enum><header>Enforcement</header><text>Section 502 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="traditional" display-inline="no-display-inline" id="H15163882D0F440FB9B00742600374039"> <paragraph id="H77D5F455EA414F1AA6468EF8D3579635" indent="up1"><enum>(x)</enum><text>If it is a prescription drug with respect to which there is a failure to comply with a requirement under section 505(c)(5).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HC926E659D5E94E5B94D33FE4DB5FBD3"><enum>(c)</enum><header>Rule of construction</header><text>The amendments made by subsections (a) and (b) may not be construed as affecting the authority of the Secretary of Health and Human Services under section 319 of the Public Health Service Act (relating to actions to respond to public health emergencies).</text></subsection></section> <section id="H0B881F23949D45CABCE707A4A567B7CA"><enum>102.</enum><header>Labeling and advertising for prescription drugs; report to Congress regarding comparative effectiveness and cost-effectiveness</header><text display-inline="no-display-inline">Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit to the Committee on Energy and Commerce in the House of Representatives, and the Committee on Health, Education, Labor, and Pensions in the Senate, a report providing a proposal for the inclusion in the labeling and advertisements for each prescription drug of information concerning the comparative effectiveness and comparative cost-effectiveness of the drug in relation to other prescription drugs that are in the same class of drugs. Such report shall include a description of the amendments to the Federal Food, Drug, and Cosmetic Act that would be necessary to enact such proposal.</text></section> <section id="H292A4955AA3C4C18B30007D758C70071"><enum>103.</enum><header>Funding for Division of Drug Marketing, Advertising, and Communications</header><text display-inline="no-display-inline">For carrying out the responsibilities of the Division of Drug Marketing, Advertising, and Communications (within the Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration), there are authorized to be appropriated $25,000,000 for fiscal year 2007, and such sums as may be necessary for each subsequent fiscal year.</text> </section> <enum>II</enum><header>Advertising for restricted medical devices</header> <section id="H983D7E211D60405A84CD40936256579B"><enum>201.</enum><header>Advertising for restricted devices</header> <subsection id="H215FC19B986F45709DD2A4B74E6CFEA5"><enum>(a)</enum><header>Advertisements intended for consumers; prior approval</header><text display-inline="yes-display-inline">Section 502(r) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352(r)</external-xref>) is amended—</text> <paragraph id="H1DFE7A9823C04C4ABDCB88AD94D55D11"><enum>(1)</enum><text>by inserting after the first period the following: <quote>In the case of an advertisement intended for consumers of a restricted device, regulations under this paragraph shall require prior approval by the Secretary of the content of the advertisement, which approval or denial shall be issued not later than 30 days after the content is submitted to the Secretary.</quote>; and</text></paragraph> <paragraph id="HA529586361044752B81042C39BBB6D42"><enum>(2) </enum><text>by striking <quote>Except in extraordinary circumstances</quote> and all that follows through <quote>prior approval</quote> and inserting the following: <quote>In the case of an advertisement not so intended, such regulations may not, except in extraordinary circumstances, require prior approval</quote>. </text></paragraph></subsection> <subsection id="HFC8D0B03B696477B94386E6CAA974E32"><enum>(b)</enum><header>Study by government accountability office; report to congressional committees</header> <paragraph id="HF156554CBFB84AE9A1892CD4DCFA5EA"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study on the impact of consumer-directed advertising on restricted device utilization and spending. Such study shall consider, for the period January 1, 2001, through December 31, 2005—</text> <subparagraph id="H83F08B3C0DDC474E8FAFFDD4CE1E4884"><enum>(A)</enum><text> the growth in retail sales of the 25 restricted devices most heavily advertised (as measured by the volume of advertisements aired or published) relative to the sales of other restricted devices;</text></subparagraph> <subparagraph id="H0926F2D21A6E4DC7AFA91EC2B6414DA"><enum>(B)</enum><text>annual retail price increases of the 25 most heavily advertised devices compared to those of other devices; and</text></subparagraph> <subparagraph id="HE4F57E3195C0494AB83D86D49270BF1C"><enum>(C)</enum><text>such other information as the Comptroller General determines is useful in assessing the impact of advertising on the national health care consumption and spending.</text></subparagraph></paragraph> <paragraph id="H7E8E1C6E979942E5AF836D0020C9004C"><enum>(2)</enum><header>Evaluation of regulatory controls and sufficiency of resources</header> <subparagraph id="H492547351C1B421600158B6F2BC8C800"><enum>(A)</enum><header>In general</header><text>In conducting the study under paragraph (1), the Comptroller General shall, in addition to considerations under such paragraph, evaluate whether—</text> <clause id="H7028BA63CDFA4EC4BF00E13DCD8AD30"><enum>(i)</enum><text>current regulatory controls are designed and implemented so as to effectively ensure that consumer-directed device advertising provides complete and accurate information concerning the safety and effectiveness considerations associated with advertised devices; and</text></clause> <clause id="H4448184A82B448BB8577C26B65EF8DDF"><enum>(ii)</enum><text>the Food and Drug Administration devotes sufficient resources to the tasks of monitoring and enforcing such controls.</text></clause></subparagraph> <subparagraph id="HFBBA36D1082B409C88AAAB6C1CB3D635"><enum>(B)</enum><header>Recommendations for congress</header><text>If the Comptroller General concludes that the design or implementation of current regulatory controls is ineffective within the meaning of subparagraph (A)(i), or that the resources allocated for their implementation are insufficient within the meaning of subparagraph (A)(ii), the Comptroller General shall develop recommendations for the Congress for remediation of the deficiencies.</text></subparagraph></paragraph> <paragraph id="H889F65137B114520BAD02C2D6B5B593B"><enum>(3)</enum><header>Definitions</header><text>For purposes of this subsection, the terms <quote>device</quote> and <quote>restricted device</quote> have the meanings that apply for purposes of the Federal Food, Drug, and Cosmetic Act.</text></paragraph> <paragraph id="H3C7FC9C3CB8349D9AD59E0CA99B53E92"><enum>(4)</enum><header>Report</header><text>Not later than July 1, 2006, the Comptroller General shall submit to the Committee on Energy and Commerce in the House of Representatives, and the Committee on Finance in the Senate, a report providing the findings of the study under paragraph (1), including (as applicable) recommendations under paragraph (2)(B).</text></paragraph></subsection></section> <section id="H07BB659A145444C882FB6C1FCF00AACF"><enum>202.</enum><header>Funding for Office of Compliance</header><text display-inline="no-display-inline">For carrying out the responsibilities of the Office of Compliance (within the Center for Devices and Radiological Health, Food and Drug Administration), there are authorized to be appropriated $5,000,000 for each of the fiscal years 2007 through 2009, and such sums as may be necessary for each subsequent fiscal year.</text></section> <enum>III</enum><header>Availability to public of objective information on drugs</header> <section id="HFFC5E718F5A54A09B792003EE1D1318"><enum>301.</enum><header>Availability of information</header> <subsection id="HC1FA050A00B34A0298BFF4AB5D8155C8"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall provide for the availability to the public of objective information on health conditions and treatments through—</text> <paragraph id="HAE1760064EC949C4AED2397446F21E60"><enum>(1)</enum><text>maintaining a toll-free telephone number to provide such information;</text></paragraph> <paragraph id="HC4C9B1A934034854BB59E21E15A79EF2"><enum>(2)</enum><text>carrying out a public information campaign to make the public aware that such information is available from the Department of Health and Human Services through such telephone number and through the Internet site www.healthfinder.gov (or successor site); and</text></paragraph> <paragraph id="H5F2F4542363945949D2D817D17F33864"><enum>(3)</enum><text>using the telephone number under paragraph (1), and the Internet site of the Food and Drug Administration, to make the public aware of the Internet site referred to in paragraph (2).</text></paragraph></subsection> <subsection id="H7168697253BD464EAF196CDC00B4C0E7"><enum>(b)</enum><header>Authorization of appropriations for public information campaign</header><text>For the purpose of carrying out subsection (a)(2), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2007 through 2009.</text></subsection></section>