[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7200 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 7200

To establish programs that use the Internet to provide to patients and 
health care practitioners coordinated information on diseases and other 
 conditions, to establish authorities that provide patients and health 
care practitioners freedom in the choice of medical treatments, 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, and in addition to the Committee on 
   the Judiciary, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To establish programs that use the Internet to provide to patients and 
health care practitioners coordinated information on diseases and other 
 conditions, to establish authorities that provide patients and health 
care practitioners freedom in the choice of medical treatments, 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--PATIENT AND PRACTITIONER RIGHTS REGARDING PRACTICE OF 
                                MEDICINE

Sec. 201. Patient and practitioner rights.
Sec. 202. General safeguards.
Sec. 203. Federal registration of unapproved treatments; determination 
                            regarding safety.
Sec. 204. Unapproved treatments; John Eisenberg forum for facilitating 
                            exchange of information in scientific and 
                            medical community.
Sec. 205. Relation to other laws.
Sec. 206. Authorization of appropriations.
    TITLE III--ADDITIONAL FORUMS FOR EXCHANGE OF HEALTH INFORMATION

Sec. 301. John Eisenberg forum regarding surgical procedures.
Sec. 302. John Eisenberg forum regarding complementary and alternative 
                            medicine; dietary supplements and food.
         TITLE IV--LEGAL IMMUNITY OF DRUG AND DEVICE COMPANIES

Sec. 401. Immunity from liability.
                      TITLE V--GENERAL PROVISIONS

Sec. 501. Definitions.
Sec. 502. 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 301 
                        of this Act or pursuant to section 485D(i) of 
                        the Public Health Service Act (as added by 
                        section 302 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 site under section 301 and the 
        Internet site under section 485D(i) of the Public Health 
        Service Act (as added by section 302 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--PATIENT AND PRACTITIONER RIGHTS REGARDING PRACTICE OF 
                                MEDICINE

SEC. 201. PATIENT AND PRACTITIONER RIGHTS.

    (a) Access to Medical Treatment.--If a patient of a qualifying 
practitioner chooses to use a drug or device offered by the 
practitioner as a treatment in the course of his or her professional 
practice, then notwithstanding the provisions of law specified in 
subsection (d), the practitioner may in accordance with this title 
provide the treatment to the patient (and the patient may use the 
treatment) without regard to whether the drug or device or use thereof 
is unapproved, including an unapproved drug or device that is made by 
the practitioner, except as provided in subsection (c).
    (b) Additional Authorities.--Notwithstanding the provisions of law 
specified in subsection (d), but subject to subsection (c), the 
following applies to a qualifying practitioner in the course of his or 
her professional practice:
            (1) The practitioner may for use in making a drug obtain 
        active ingredients and other substances from sources other than 
        approved drugs, including active ingredients in the form of 
        bulk drugs.
            (2) The practitioner may make a new drug through providing 
        instructions to a licensed pharmacist.
            (3) A person may supply to the practitioner active 
        ingredients and other substances described in paragraph (1), 
        and may pursuant to paragraph (2) supply such ingredients and 
        substances to a pharmacist.
            (4) A person may supply to the practitioner, and the 
        practitioner may receive, an unapproved drug or an unapproved 
        device that is approved for commercial distribution in any of 
        the following foreign countries: Australia, Canada, France, 
        Germany, Holland, Japan, Sweden, and the United Kingdom.
            (5) The practitioner may otherwise introduce a drug or 
        device into interstate commerce; deliver a drug or device for 
        introduction into such commerce; transport a drug or device in 
        such commerce; receive a drug or device in such commerce and 
        deliver the drug or device; and hold a drug or device for sale 
        after shipment of the drug or device in such commerce.
    (c) Restriction Regarding Certain Active Ingredients.--The 
authority established in subsections (a) and (b) for a practitioner to 
make a drug applies only to the use of an active ingredient that--
            (1) is an ingredient in an approved drug; or
            (2) is an ingredient in an unapproved drug that is approved 
        for commercial distribution in a foreign country specified in 
        subsection (b)(4).
    (d) Inapplicability of Certain Provisions of Federal, Food, Drug, 
and Cosmetic Act.--For purposes of subsections (a) and (b), the 
provisions of law specified in this subsection are section 351 of the 
Public Health Service Act and the following provisions of the Federal 
Food, Drug, and Cosmetic Act: sections 501(a)(2)(B) and 501(e) through 
501(h); section 502(f)(1); section 505; section 510; section 513; and 
section 515.
    (e) Limitation.--Subsections (a) and (b) are subject to sections 
202, 203, and 205, and to the definition of the term ``drug'' 
established in section 501(3).

SEC. 202. GENERAL SAFEGUARDS.

    In the case of an activity under subsection (a) or (b) of section 
201 that would in the absence of such subsection be a violation of the 
Federal Food, Drug, and Cosmetic Act or section 351 of the Public 
Health Service Act, such subsection is effective with respect to a 
qualifying practitioner only if the following conditions are met:
            (1) Engaging in the activity is not a violation of the law 
        of the State in which the activity is carried out.
            (2) Before providing an unapproved treatment to a patient, 
        such practitioner provides to the patient a statement in 
        writing in accordance with this paragraph and obtains the 
        signature of the patient on the statement as a declaration that 
        the patient understands the statement and consents to receiving 
        the treatment. The statement is in accordance with this 
        paragraph if the following conditions are met:
                    (A) The statement provides as follows:
                            (i) That the approval of the Food and Drug 
                        Administration has not been obtained for the 
                        drug, device, or use involved, and that such 
                        Administration is the Federal agency whose 
                        mission is to protect the public health 
                        regarding drugs and devices.
                            (ii) That the practitioner is not 
                        authorized to provide the treatment without the 
                        clearance of the Secretary under section 203 of 
                        this Act, but such clearance provides a lesser 
                        standard of protecting the public health than 
                        approval by the Food and Drug Administration 
                        under the provisions of law otherwise 
                        applicable, and such clearance does not 
                        authorize the commercial distribution of the 
                        treatment.
                    (B) The statement identifies the health condition 
                for which the treatment is to be provided to the 
                patient, and provides the instructions that the 
                practitioner expects the patient to follow with respect 
                to the treatment.
                    (C) The statement provides the opinion of the 
                practitioner concerning the risks and benefits of the 
                treatment, including any expected possible side 
                effects, and the statement describes in general terms 
                the standard of medical care for the health condition 
                involved and explains the manner in which the treatment 
                varies from such standard.
            (3) In the case of treatment with an unapproved drug or 
        device made by the practitioner or obtained by the practitioner 
        from another person, the practitioner does not in distributing 
        the drug or device, other than to patients, impose a charge in 
        excess of the amount necessary to recover the costs of making 
        or obtaining, as applicable, the drug or device and providing 
        for transporting the drug or device to other practitioners. 
        This paragraph is subject to the definition of the term 
        ``drug'' established in section 501(3).
            (4) The practitioner is not an employee or agent of any 
        drug or device company, subject to section 401(c)(2).
            (5) The practitioner does not, other than in communicating 
        with the patients of the practitioner, advertise or promote the 
        treatment. This paragraph does not with respect to the 
        treatment prohibit publishing articles or letters in scientific 
        or medical journals or publications; speaking or otherwise 
        providing information at scientific conferences or meetings; or 
        any other form of communicating with professionals in 
        scientific or medical fields. Except for the presentation of 
        information to the public pursuant to the program under section 
        204, this paragraph does with respect to the treatment prohibit 
        providing information in any manner typically used in the 
        course of business to market products or services to the 
        general public.

SEC. 203. FEDERAL REGISTRATION OF UNAPPROVED TREATMENTS; DETERMINATION 
              REGARDING SAFETY.

    (a) In General.--
            (1) Submission and clearance of registration.--In the case 
        of an unapproved treatment whose provision to a patient under 
        section 201(a) would in the absence of such section be a 
        violation of the Federal Food, Drug, and Cosmetic Act or 
        section 351 of the Public Health Service Act, section 201(a) is 
        effective with respect to the provision of the treatment to the 
        patient by a qualifying practitioner only if the following 
        conditions are met:
                    (A) Before providing the treatment to the patient--
                            (i) such practitioner submitted to the 
                        Secretary a registration in accordance with 
                        subsection (b); and
                            (ii) the Secretary made a determination 
                        that there is no clear and convincing evidence 
                        that the treatment is unsafe.
                    (B) In the case of a registration that has been 
                cleared, the practitioner submits to the Secretary 
                supplemental notices in accordance with subsection (d).
            (2) Administration of program.--This section shall be 
        carried out by the Secretary acting through the Commissioner of 
        Food and Drugs. The Secretary shall establish within the Food 
        and Drug Administration an office or other administrative unit 
        to carry out this section and section 204.
            (3) Definitions.--For purposes of this section:
                    (A) The term ``clear'', with respect to a 
                registration under paragraph (1)(A), means a 
                determination described in clause (ii) of such 
                paragraph.
                    (B) The term ``disapprove'', with respect to a 
                registration under paragraph (1)(A), means a 
                determination by the Secretary that the treatment 
                involved fails to meet the standard for clearance under 
                clause (ii) of such paragraph.
    (b) Registration Requirements.--For purposes of subsection 
(a)(1)(A)(i), a registration under such subsection regarding a 
qualifying practitioner is in accordance with this subsection if the 
following conditions are met:
            (1) The registration provides the identity and business 
        address of such practitioner and such information regarding the 
        medical licensing of the practitioner in the State involved as 
        the Secretary may require.
            (2) The registration describes the unapproved treatment 
        involved and states that it is the intent of the practitioner 
        to provide the treatment to one or more patients.
            (3) The registration contains all information that, under 
        subparagraphs (B) and (C) of section 202(2), is required to be 
        provided to the patient in the statement under such section.
            (4) The registration contains such information regarding 
        such treatment, and is accompanied by such samples and 
        components regarding the treatment, as the Secretary may 
        require.
            (5) The registration contains a statement authorizing the 
        Secretary to disclose, for purposes of the program under 
        section 204, the identity of the practitioner, the business 
        address of the practitioner, and information regarding the 
        treatment.
    (c) Date Certain for Final Agency Determination.--
            (1) In general.--Not later than 90 days after the date on 
        which a registration under subsection (a) is submitted to the 
        Secretary in accordance with subsection (b), the Secretary 
        shall clear the registration or disapprove clearance of the 
        registration, and shall in writing provide to the qualifying 
        practitioner who submitted the registration a statement of 
        whether or not the registration has been cleared. If clearance 
        was disapproved, the statement shall explain the reasons 
        underlying the disapproval.
            (2) Deemed clearance.--
                    (A) Noncompliance of agency regarding timeframe.--
                If the Secretary does not within the period of time 
                specified in paragraph (1) clear a registration under 
                subsection (a) or disapprove clearance of the 
                registration, the registration is deemed to be cleared.
                    (B) Registration of additional practitioners 
                pursuant to previously cleared registration.--If a 
                registration submitted by a qualifying practitioner 
                under subsection (a) is cleared, then in the case of 
                the unapproved treatment involved, registrations 
                submitted by other qualifying practitioners with 
                respect to such treatment are upon submission in 
                accordance with subsection (b) deemed to have been 
                cleared.
    (d) Supplemental Notices.--
            (1) In general.--For purposes of subsection (a)(1)(B), 
        supplemental notices under such subsection are in accordance 
        with this subsection if the following conditions are met:
                    (A) The supplemental notices provide updates of 
                information provided in cleared registrations by 
                providing such information on the effects on patients 
                of the unapproved treatments involved, including 
                information on patient outcomes, as may be available to 
                the qualifying practitioner involved.
                    (B) The notices are submitted to the Secretary at 
                such intervals as may be specified by the Secretary, 
                subject to paragraph (2).
            (2) Limitation on frequency of notices; emergency 
        situations.--The Secretary may not require submission of 
        supplemental notices under subsection (a)(1)(B) more frequently 
        than quarterly, except that the Secretary may establish such 
        requirements relating to supplemental notices on emergency 
        situations as the Secretary determines to be appropriate.
    (e) Criteria.--
            (1) In general.--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.
            (2) Standard for clearance.--In establishing criteria under 
        paragraph (1) regarding the standard for clearance under 
        subsection (a)(1)(A)(ii), the Secretary is subject to the 
        following:
                    (A) In the case of an unapproved drug or an 
                unapproved use of a drug, the criteria may not be as 
                stringent as criteria for determining that the drug or 
                use is safe for purposes of section 505 of the Federal 
                Food, Drug, and Cosmetic Act or section 351 of the 
                Public Health Service Act.
                    (B) In the case of an unapproved device or an 
                unapproved use of a device, the criteria may not be as 
                stringent as criteria under section 513(a) of the 
                Federal Food, Drug, and Cosmetic Act for determining 
                that there is a reasonable assurance of the safety of a 
                device.
                    (C) The criteria shall provide for the review of 
                any relevant information published in scientific or 
                medical journals.
                    (D) The criteria may not require as a condition of 
                clearing a treatment that information relevant to the 
                treatment has been published in one or more scientific 
                or medical journals.
            (3) Consideration of capacity of practitioners.--Criteria 
        under paragraph (1) shall take into account the capacity of 
        qualifying practitioners to comply with the criteria (as 
        compared to the capacity of entities that submit applications 
        under section 505 or 515 of the Federal Food, Drug, and 
        Cosmetic Act), and shall make reasonable efforts to avoid 
        establishing criteria that would present a significant 
        disincentive for such practitioners to develop unapproved 
        treatments.

SEC. 204. UNAPPROVED TREATMENTS; JOHN EISENBERG FORUM FOR FACILITATING 
              EXCHANGE OF INFORMATION IN SCIENTIFIC AND MEDICAL 
              COMMUNITY.

    (a) In General.--With respect to registrations cleared under 
section 203 and supplemental notices under such section regarding the 
registrations, the Secretary, acting through the Commissioner of Food 
and Drugs, shall (directly or through contract) establish a program in 
accordance with the following:
            (1) The Secretary shall maintain information from the 
        registrations and notices and, subject to subsection (b), make 
        the information available to scientific and medical entities 
        and the general public through establishing one or more 
        Internet sites and posting the information on such site.
            (2) The Secretary shall post on the Internet site 
        appropriate comments and information provided in response to 
        the information placed on the site under paragraph (1).
            (3) The Secretary shall carry out paragraphs (1) and (2) in 
        a manner reasonably calculated to provide a forum for obtaining 
        and disseminating information, including clinical data, toward 
        the following goals:
                    (A) Identifying new drugs and devices and uses of 
                such 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 new drugs and devices and uses of 
                such drugs and devices that constitute a threat to the 
                public health.
                    (C) Obtaining 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) Certain Authorities.--The posting by the Secretary of 
information on the Internet site under subsection (a) is subject to the 
following:
            (1) The Secretary shall post the identity and business 
        address of qualifying practitioners with respect to whom 
        registrations under section 203 have been cleared.
            (2) In the case of an unapproved drug or an unapproved 
        device made by a qualifying practitioner, the Secretary may not 
        post information sufficient for others to make the drug or 
        device unless such practitioner has in advance so authorized 
        the Secretary.
            (3) The Secretary may impose reasonable restrictions on the 
        format and volume of information to be posted and on the 
        frequency of postings.
    (c) Clinical Guidelines.--
            (1) In general.--With respect to a registration cleared 
        under section 203, if the Secretary determines that clinical 
        data on the unapproved treatment involved that has been 
        submitted to the Secretary pursuant to such section and this 
        section may be sufficient to demonstrate that the treatment is 
        safe, pure, and potent for purposes of section 351 of the 
        Public Health Service Act (in the case of a biological 
        product), or is safe and effective for purposes of section 505 
        of the Federal Food, Drug, and Cosmetic Act (in the case of a 
        new drug), or that there may be a reasonable assurance of the 
        safety and effectiveness of the treatment for purposes of 
        section 515 of such Act (in the case of a device), then the 
        Secretary--
                    (A) shall develop, and publish on the Internet site 
                under subsection (a)(1), clinical guidelines on the 
                treatment; and
                    (B) shall submit such guidelines to the 
                Commissioner of Food and Drugs.
            (2) Effect regarding applications to food and drug 
        administration.--With respect to a biological product for which 
        an application is submitted under section 351 of the Public 
        Health Service Act, or a new drug for which an application is 
        submitted under section 505 of the Federal Food, Drug, and 
        Cosmetic Act, or a device for which an application is submitted 
        under section 515 of such Act, if clinical guidelines under 
        paragraph (1) regarding such product, drug, or device (as the 
        case may be) have been submitted to the Commissioner of Food 
        and Drugs, then the following applies to the application:
                    (A) If the clinical guidelines are submitted before 
                the application, such Commissioner shall approve or 
                disapprove the application not later than 120 days 
                after the date on which the application is submitted.
                    (B) If the application is submitted before the 
                clinical guidelines, such Commissioner shall approve or 
                disapprove the application not later than 120 days 
                after the date on which the clinical guidelines are 
                submitted.
                    (C) If the Commissioner disapproves the 
                application, the Commissioner shall submit to the 
                Secretary, not later than 30 days after the date of the 
                disapproval, a report that provides the reasons 
                underlying the disapproval.
            (3) Noncompliance of agency regarding timeframe.--If the 
        Commissioner of Food and Drugs does not within the period of 
        time specified in paragraph (2) approve or disapprove an 
        application to which such paragraph applies, the application is 
        deemed to be approved.
    (d) Rule of Construction Regarding Supplemental Applications; 
Consideration of Clinical Guidelines.--In the case of a person who 
holds an approved application under section 351 of the Public Health 
Service Act or section 505 or 515 of the Federal Food, Drug, and 
Cosmetic Act, this section may not be construed as having any legal 
effect with respect to the authority to submit a supplemental 
application to seek approval of a change for the labeling of the 
product involved or the indications for use of the product, other than 
the legal effects of the timeframes under paragraph (2) of subsection 
(c) and the deeming of approval under paragraph (3) of such subsection, 
except that--
            (1) clinical guidelines under paragraph (1) of such 
        subsection may be considered by the Commissioner of Food and 
        Drugs in reviewing the supplemental application; and
            (2) such guidelines may, in the case of a drug with an 
        approved application, be considered by the Commissioner for 
        purposes of section 505A(c) of the Federal Food, Drug, and 
        Cosmetic Act.
    (e) 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. 205. RELATION TO OTHER LAWS.

    (a) Controlled Substances Act.--In the case of a controlled 
substance, the authority provided pursuant to section 201 for a 
qualifying practitioner with respect to a drug is subject to the 
compliance of the practitioner with each provision of the Controlled 
Substances Act that is applicable with respect to the drug.
    (b) State Law.--This title does not supersede any law of a State or 
political subdivision of a State, including laws governing rights and 
duties among practitioners and patients.
    (c) Other Provisions.--This Act does not have any legal effect on 
any of the following:
            (1) Section 561 of the Federal Food, Drug, and Cosmetic Act 
        (relating to expanded access to investigational drugs and 
        devices).
            (2) With respect to an unapproved drug or device for which 
        a qualifying practitioner is the original maker, and with 
        respect to an unapproved drug or device made by a manufacturer 
        in a foreign country (in the case of a drug or device to which 
        section 201(b)(4) applies)--
                    (A) agreements required by such maker as a 
                condition of providing to a qualifying practitioner a 
                supply of the drug or device or instructions for making 
                the drug or device; or
                    (B) provisions regarding patents or related 
                matters.

SEC. 206. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out the functions 
under this title of the Commissioner of Food and Drugs (other than 
providing for Internet sites under section 204(a)(1) or approving an 
application, disapproving an application, or reporting on a disapproval 
pursuant to section 204(c)(2)), there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 2008 through 
2012.
    (b) Internet Sites.--For the purpose of providing for Internet 
sites under section 204(a)(1), there are authorized to be appropriated 
$50,000,000 for fiscal year 2008, and such sums as may be necessary for 
each of the fiscal years 2009 through 2012.

    TITLE III--ADDITIONAL FORUMS FOR EXCHANGE OF HEALTH INFORMATION

SEC. 301. 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. 302. 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 IV--LEGAL IMMUNITY OF DRUG AND DEVICE COMPANIES

SEC. 401. IMMUNITY FROM LIABILITY.

    (a) Loss Arising From Use of Unapproved Treatments by 
Practitioners.--
            (1) In general.--A drug or device company (referred to in 
        this section as a ``company'') is immune from suit and 
        liability under Federal and State law with respect to all 
        claims for loss arising from the use of a relevant unapproved 
        treatment by a practitioner under a cleared registration under 
        section 203(a).
            (2) Relevant unapproved treatment.--For purposes of this 
        section, the term ``relevant unapproved treatment'', with 
        respect to a company, means a treatment that uses an approved 
        drug or device that is manufactured by the company, which use--
                    (A) is an unapproved use that does not involve any 
                changes to the drug or device as manufactured by the 
                company; or
                    (B) involves changes to the drug or device as 
                manufactured by the company and causes the drug or 
                device to be unapproved.
            (3) Loss.--For purposes of this subsection, the term 
        ``loss'' means any type of loss, including--
                    (A) death;
                    (B) physical, mental, or emotional injury, illness, 
                disability, or condition;
                    (C) fear of physical, mental, or emotional injury, 
                illness, disability, or condition, including any need 
                for medical monitoring; and
                    (D) loss of or damage to property, including 
                business interruption loss.
            (4) Rule of construction regarding use of unapproved 
        treatment.--For purposes of paragraph (1), a practitioner shall 
        be considered to have used a relevant unapproved treatment if 
        the practitioner--
                    (A) treated himself or herself with the treatment; 
                or
                    (B) treated a patient with the treatment, whether 
                by administering the treatment to the patient directly 
                or by providing for self-administration by the patient.
    (b) Provision of Information to Practitioners Upon Request.--
            (1) In general.--A company is immune from suit and 
        liability under Federal and State law with respect to any claim 
        arising from the provision by the company of information on a 
        drug or device manufactured by the company in circumstances in 
        which--
                    (A) the information is provided to a practitioner 
                in response to a request made to the company by the 
                practitioner; and
                    (B) the information is reasonably believed by the 
                company to be accurate.
            (2) Relation to cleared registration.--Paragraph (1) 
        applies without regard to whether the drug or device involved 
        is used as or in a relevant unapproved treatment for which a 
        cleared registration under section 203(a) has been obtained.
    (c) Obtaining Information From Practitioners.--
            (1) In general.--In the case of a relevant unapproved 
        treatment for which a cleared registration under section 203(a) 
        is in effect, the immunity under this section for the company 
        involved may not be considered inapplicable on the basis that 
        the company sought or obtained information on the treatment 
        from practitioners or patients, whether through the forum under 
        section 204(a) or otherwise, including circumstances in which 
        the company makes a grant to or enters into a contract with a 
        practitioner for the purpose of obtaining clinical data from 
        the practitioner on the unapproved treatment.
            (2) Status of practitioner as employee or agent.--In the 
        case of a relevant unapproved treatment for which a cleared 
        registration under section 203(a) is in effect, a practitioner 
        may not be considered to be an employee or agent of the company 
        involved for purposes of section 202(4) solely on the basis 
        that the practitioner is the recipient of a grant or contract 
        referred to in paragraph (1).

                      TITLE V--GENERAL PROVISIONS

SEC. 501. DEFINITIONS.

    For purposes of this Act:
            (1) Subject to the definition of the term ``drug'' 
        established in paragraph (3), the term ``approved'', with 
        respect to a new drug or a device, means a new drug or a device 
        that is approved or cleared under section 505, 513, or 515 of 
        the Federal Food, Drug, and Cosmetic Act, or under section 351 
        of the Public Health Service Act.
            (2) The terms ``device'', ``label'', ``labeling'', ``new 
        drug'', and ``State'' have the meanings given such terms in 
        section 201 of the Federal Food, Drug, and Cosmetic Act.
            (3) The term ``drug'' has the meaning given such term in 
        section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, 
        including provisions added by section 10(a) of the Dietary 
        Supplement Health and Education Act of 1994 (Public Law 103-
        417; 108 Stat. 4325, 4332) (relating to exceptions providing 
        that dietary supplements, as defined in section 201(ff) of the 
        Federal Food, Drug, and Cosmetic Act, are not drugs). Such 
        definition applies to paragraph (1) of this section, to section 
        201(d), to section 202(3), and to the other provisions of this 
        Act.
            (4) The term ``drug or device company'' means an entity 
        that--
                    (A) has or has held an approved application for a 
                new drug under section 505 of the Federal Food, Drug, 
                and Cosmetic Act or under section 351 of the Public 
                Health Service Act, or an approved application for a 
                device under section 515 of the Federal Food, Drug, and 
                Cosmetic Act;
                    (B) is the manufacturer of a device for which a 
                regulation under subsection (d) or (e) of section 513 
                of the Federal Food, Drug, and Cosmetic Act has been 
                promulgated, or for which an order under subsection (f) 
                of such section has been made;
                    (C) is the maker of a drug or device that is 
                approved for commercial distribution in a foreign 
                country; or
                    (D) is a commercial distributor of a drug or a 
                device for an entity specified in subparagraph (A) or 
                (B).
            (5) The term ``make'', with respect to a drug or device, 
        means to manufacture, prepare, propagate, compound, or process 
        the drug or device.
            (6) The term ``qualifying practitioner'' means a 
        practitioner licensed by law to prescribe or administer drugs 
        or devices.
            (7) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
            (8) Subject to the definition of the term ``drug'' 
        established in paragraph (3), the term ``unapproved'', with 
        respect to a new drug or a device, means that the drug or 
        device is not approved within the meaning of paragraph (1).
            (9) The term ``unapproved treatment'' means treatment with 
        or diagnostic application of an unapproved drug, unapproved 
        device, or unapproved use.
            (10) The term ``unapproved use'', with respect to a new 
        drug or a device, means a use of an approved new drug or a 
        device for a purpose not included in the labeling approved for 
        the drug or device pursuant to the provisions specified in 
        paragraph (1).

SEC. 502. EFFECTIVE DATES.

    (a) In General.--Subject to subsection (b)--
            (1) title II takes effect on the date on which the final 
        rules required under sections 203(e)(1) and 204(e) take effect;
            (2) section 301 takes effect on the date on which the final 
        rule required under subsection (d) of such section takes 
        effect; and
            (3) the amendment made by section 302 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 203(e)(1), 204(e), and 301(d) 
of this Act, and section 485D(i)(5) of the Public Health Service Act 
(as added by section 302 of this Act), take effect on the date of the 
enactment of this Act.
                                 <all>