[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7199 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 7199

To establish programs that use the Internet to provide to patients and 
health care practitioners coordinated information on diseases and other 
                  conditions, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 28, 2008

  Mr. Cannon introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To establish programs that use the Internet to provide to patients and 
health care practitioners coordinated information on diseases and other 
                  conditions, 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 ``Medical Information and Treatment 
Access Act''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
  TITLE I--FEDERAL INTERNET SITE FOR CONSOLIDATION AND TRANSLATION OF 
              INFORMATION ON DISEASES AND OTHER CONDITIONS

Sec. 101. Internet site.
     TITLE II--ADDITIONAL FORUMS FOR EXCHANGE OF HEALTH INFORMATION

Sec. 201. Forum regarding off-label uses of new drugs and devices.
Sec. 202. John Eisenberg forum regarding surgical procedures.
Sec. 203. John Eisenberg forum regarding complementary and alternative 
                            medicine; dietary supplements and food.
                     TITLE III--GENERAL PROVISIONS

Sec. 301. Definitions.
Sec. 302. Effective dates.

SEC. 3. FINDINGS.

    The Congress finds as follows:
            (1) The Congress and the American people desire to live 
        healthy lives and foster an effective and efficient health care 
        system. This system requires timely, accurate, and ever-
        improving information resources. This will foster maximization 
        of health care outcomes and help health care practitioners and 
        patients partner for more effective results.
            (2) The Internet is a unique tool offering access to great 
        volumes of information. Some is accurate and some is not. There 
        has also been extensive government investment in placing 
        medical information on the Internet in many diverse places.
            (3) There is a need to consolidate and translate this 
        myriad of information for physicians and consumers, from the 
        listing of clinical trials to the protocols for treatment of 
        various diseases and conditions, as well as the integration of 
        new discoveries and the evaluations of outcomes-based 
        examinations of drugs and devices for conditions other than 
        those for which they are already approved. This will lead to 
        more accurate treatment, fewer medical errors, and more 
        successful outcomes, while also protecting patients, a 
        physician's right to practice medicine, and a patient's right 
        to access the health care the patient desires.
            (4) The Food and Drug Administration is uniquely qualified 
        to assist the Nation in fulfilling this mission to improve 
        health care for the benefit of Americans. The Administration 
        already coordinates the information needs of many government 
        agencies and equivalent regulatory bodies in other countries.
            (5) In providing Internet-based forums for obtaining and 
        disseminating health-related information (including information 
        on surgical procedures; complimentary and alternative medicine; 
        dietary supplements and food; and unapproved treatments), the 
        Food and Drug Administration should work closely with 
        educational institutions, schools of medicine, and other 
        appropriate private entities and ensure that the expertise of 
        such entities is appropriately utilized.

  TITLE I--FEDERAL INTERNET SITE FOR CONSOLIDATION AND TRANSLATION OF 
              INFORMATION ON DISEASES AND OTHER CONDITIONS

SEC. 101. INTERNET SITE.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall carry out a program 
whose mission is, through an Internet site maintained for purposes of 
the program--
            (1) to consolidate and translate health care information 
        that is available to the public from Federal agencies, linking 
        the various health-related Internet sites of such agencies; and
            (2) to assist in the translation and reporting of disease 
        or condition protocols for physicians and lay persons.
    (b) Information on Diseases and Other Conditions.--The Secretary 
shall ensure that the Internet site under subsection (a) has capacities 
that enable a user of the site to enter the name of a disease or other 
health condition and obtain Internet links appropriate to health care 
providers, and links appropriate to lay persons, that provide--
            (1) an explanation of the health condition; and
            (2) information on all available treatment protocols, 
        including--
                    (A) standard medical practice protocols; and
                    (B) any clinical trials, and any outcomes-based 
                treatment protocols, that--
                            (i) are being conducted or supported by the 
                        National Institutes of Health;
                            (ii) are included in the registry and 
                        results data bank under section 402(j) of the 
                        Public Health Service Act (42 U.S.C. 282(j));
                            (iii) are being conducted pursuant to the 
                        Federal Food, Drug, and Cosmetic Act or section 
                        351 of the Public Health Service Act;
                            (iv) are being conducted pursuant to 
                        section 201 of this Act; or
                            (v) are identified pursuant to section 201 
                        or 202 of this Act or pursuant to section 
                        485D(i) of the Public Health Service Act (as 
                        added by section 203 of this Act).
    (c) Federal Databases.--Internet links under subsection (b) shall 
include the following:
            (1) Links that provide information on how to enroll in a 
        clinical trial referred to in subsection (b)(2)(B) and how to 
        be treated under an outcomes-based treatment protocol referred 
        to in such subsection.
            (2) Links to Federal electronic databases that are 
        available to the public and provide disease-specific or 
        condition-specific information, including such databases of the 
        National Institutes of Health, the Centers for Disease Control 
        and Prevention, and the Food and Drug Administration.
            (3) A link to the Internet site under section 204(a) 
        (relating to research and treatments carried out pursuant to 
        section 201, and the identity of the health care practitioners 
        involved).
            (4) A link to the Internet sites under sections 201 and 202 
        of this Act and the Internet site under section 485D(i) of the 
        Public Health Service Act (as added by section 203 of this 
        Act).
    (d) Date Certain for Operation of Program.--The Internet site under 
subsection (a) shall be established and ready for use by health care 
practitioners and lay persons not later than two years after the date 
of the enactment of this Act.

     TITLE II--ADDITIONAL FORUMS FOR EXCHANGE OF HEALTH INFORMATION

SEC. 201. FORUM REGARDING OFF-LABEL USES OF NEW DRUGS AND DEVICES.

    (a) In General.--The Secretary, acting through the Commissioner of 
Food and Drugs, shall (directly or through contract) establish a 
program under which the following occur:
            (1) Health care practitioners submit to the Secretary 
        information obtained in the course of their professional 
        practices regarding off-label uses of new drugs and devices.
            (2) The Secretary maintains the information received under 
        paragraph (1); makes such information available to health care 
        practitioners and the general public through one or more 
        Internet sites; and receives, maintains, and makes available 
        through such site appropriate comments and information provided 
        in response to such information.
            (3) The Secretary carries out paragraph (2) in a manner 
        reasonably calculated to provide a forum for obtaining and 
        disseminating information, including clinical data, toward the 
        following goals:
                    (A) Identifying off-label uses of new drugs and 
                devices that are reasonable candidates for approval 
                under section 505 or 515 of the Federal Food, Drug, and 
                Cosmetic Act or under section 351 of the Public Health 
                Service Act.
                    (B) Identifying off-label uses of new drugs and 
                devices that constitute a threat to the public health.
                    (C) Making available to the Secretary information 
                for uses with respect to promoting innovations in 
                evidence-based clinical practice and health care 
                technologies under title IX of the Public Health 
                Service Act.
    (b) Voluntary Participation.--Subsection (a) may not be construed 
as requiring that any health care practitioner or other person 
participate in the program under such subsection.
    (c) Certain Authorities.--The posting by the Secretary of 
information on an Internet site under subsection (a) is subject to the 
following:
            (1) The Secretary may not post information submitted by a 
        health care practitioner unless the practitioner authorizes the 
        Secretary to include in the posting the identity and the 
        business address of the practitioner.
            (2) The Secretary may impose reasonable restrictions on the 
        format and volume of information to be posted and on the 
        frequency of postings.
    (d) Criteria.--Not later than one year after the date of the 
enactment of this Act, the Secretary shall by regulation issue criteria 
for carrying out this section.

SEC. 202. JOHN EISENBERG FORUM REGARDING SURGICAL PROCEDURES.

    (a) In General.--The Secretary, acting through the Commissioner of 
Food and Drugs, shall (directly or through contract) establish a 
program under which the following occur:
            (1) Health care practitioners submit to the Secretary 
        information obtained in the course of their professional 
        practices regarding surgical procedures.
            (2) The Secretary maintains the information received under 
        paragraph (1); makes such information available to health care 
        practitioners and the general public through one or more 
        Internet sites; and receives, maintains, and makes available 
        through such site appropriate comments and information provided 
        in response to such information.
            (3) The Secretary carries out paragraph (2) in a manner 
        reasonably calculated to provide a forum for obtaining and 
        disseminating information, including clinical data, toward the 
        following goals:
                    (A) Identifying innovative surgical procedures.
                    (B) Identifying surgical procedures that constitute 
                a threat to the public health.
                    (C) Making available to the Secretary information 
                for uses with respect to promoting innovations in 
                evidence-based clinical practice and health care 
                technologies under title IX of the Public Health 
                Service Act.
    (b) Voluntary Participation.--Subsection (a) may not be construed 
as requiring that any health care practitioner or other person 
participate in the program under such subsection.
    (c) Certain Authorities.--The posting by the Secretary of 
information on an Internet site under subsection (a) is subject to the 
following:
            (1) The Secretary may not post information submitted by a 
        health care practitioner unless the practitioner authorizes the 
        Secretary to include in the posting the identity and the 
        business address of the practitioner.
            (2) The Secretary may impose reasonable restrictions on the 
        format and volume of information to be posted and on the 
        frequency of postings.
    (d) Criteria.--Not later than one year after the date of the 
enactment of this Act, the Secretary shall by regulation issue criteria 
for carrying out this section.

SEC. 203. JOHN EISENBERG FORUM REGARDING COMPLEMENTARY AND ALTERNATIVE 
              MEDICINE; DIETARY SUPPLEMENTS AND FOOD.

    Section 485D of the Public Health Service Act is amended--
            (1) by redesignating subsections (i) and (j) as subsections 
        (j) and (k), respectively; and
            (2) by adding after subsection (h) the following 
        subsection:
    ``(i) John Eisenberg Forum for Exchange of Information.--
            ``(1) In general.--The Director of the Center, in 
        consultation with the Commissioner of Food and Drugs, shall 
        (directly or through contract) establish a program under which 
        the following occur:
                    ``(A) Health care practitioners submit to the 
                Director information obtained in the course of their 
                professional practices regarding complementary and 
                alternative treatment, diagnostic and prevention 
                modalities, disciplines and systems.
                    ``(B) The Director maintains the information 
                received under subparagraph (A); makes such information 
                available to health care practitioners and the general 
                public through establishing one or more Internet sites; 
                and receives, maintains, and makes available through 
                such site appropriate comments and information provided 
                in response to such information.
                    ``(C) The Director carries out subparagraph (B) in 
                a manner reasonably calculated to provide a forum for 
                obtaining and disseminating information, including 
                clinical data, toward the following goals:
                            ``(i) Identifying alternative treatment, 
                        diagnostic and prevention systems, modalities, 
                        and disciplines that should be integrated with 
                        the practice of conventional medicine as a 
                        complement to such medicine and integrated into 
                        health care delivery systems in the United 
                        States.
                            ``(ii) Identifying any alternative medical 
                        practices or procedures that constitute a 
                        threat to the public health.
                            ``(iii) Making available to the 
                        Commissioner of Food and Drugs information for 
                        uses with respect to promoting innovations in 
                        evidence-based clinical practice and health 
                        care technologies under title IX of the Public 
                        Health Service Act.
            ``(2) Dietary supplements and food.--In consultation with 
        the Commissioner of Food and Drugs, the Director of the Center 
        shall carry out the following:
                    ``(A) Activities under paragraph (1) shall include 
                carrying out such paragraph with respect to information 
                that relates to the effects of dietary supplements and 
                food on diseases and disorders and is obtained by the 
                practitioners in the course of their professional 
                practices and submitted to the Director.
                    ``(B) With respect to paragraph (1)(C) as applied 
                for purposes of this paragraph, the goals shall be the 
                following:
                            ``(i) Identifying dietary supplements and 
                        food and uses of such supplements and food that 
                        are of clinical benefit in treating particular 
                        diseases or disorders.
                            ``(ii) As appropriate, providing for the 
                        publication of authoritative statements, within 
                        the meaning of section 403(r)(3)(C)(i) of the 
                        Federal Food, Drug, and Cosmetic Act, about the 
                        relationship between a nutrient and a disease 
                        or health-related condition.
                            ``(iii) Carrying out paragraph (1)(C)(iii) 
                        with respect to dietary supplements.
            ``(3) Voluntary participation.--Paragraph (1) may not be 
        construed as requiring that any health care practitioner or 
        other person participate in the program under such paragraph.
            ``(4) Certain authorities.--The posting by the Director of 
        the Center of information on the Internet site under paragraph 
        (1) is subject to the following:
                    ``(A) The Director may not post information 
                submitted by a health care practitioner unless the 
                practitioner authorizes the Director to include in the 
                posting the identity and the business address of the 
                practitioner.
                    ``(B) The Director may impose reasonable 
                restrictions on the format and volume of information to 
                be posted and on the frequency of postings.
            ``(5) Criteria.--Not later than one year after the date of 
        the enactment of the Medical Information and Treatment Access 
        Act, the Secretary shall by regulation issue criteria for 
        carrying out this subsection.
            ``(6) Definitions.--For purposes of this subsection, the 
        terms `dietary supplement' and `food' have the meaning given 
        such terms in section 201 of the Federal Food, Drug, and 
        Cosmetic Act.''.

                     TITLE III--GENERAL PROVISIONS

SEC. 301. DEFINITIONS.

    For purposes of this Act:
            (1) The terms ``device'', ``labeling'', and ``new drug'' 
        have the meanings given such terms in section 201 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301).
            (2) The term ``off-label use'', with respect to a new drug 
        or a device, means a use not included in the labeling approved 
        for the drug or device pursuant to section 505, 510, or 515 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360c, 
        360e) or section 351 of the Public Health Service Act (42 
        U.S.C. 262).
            (3) The term ``Secretary'' means the Secretary of Health 
        and Human Services.

SEC. 302. EFFECTIVE DATES.

    (a) In General.--Subject to subsection (b)--
            (1) sections 201 and 202 take effect on the date on which a 
        final rule takes effect pursuant to sections 201(d) and 202(d), 
        respectively; and
            (2) the amendment made by section 203 takes effect on the 
        date on which the final rule required under section 485D(i)(5) 
        of the Public Health Service Act (as added by such amendment) 
        takes effect.
    (b) Issuance of Criteria.--Sections 201(d) and 202(d) of this Act 
and section 485D(i)(5) of the Public Health Service Act (as added by 
section 203 of this Act) take effect on the date of the enactment of 
this Act.
                                 <all>