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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3196 Introduced in House (IH)]

109th CONGRESS
  1st Session
                                H. R. 3196

     To amend the Public Health Service Act to expand the scope of 
information required for the data bank on clinical trials of drugs, and 
                          for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             June 30, 2005

Mr. Waxman (for himself, Mr. Markey, Mr. Brown of Ohio, Ms. Schakowsky, 
 Mr. Gene Green of Texas, Mr. Allen, Mr. George Miller of California, 
 Mr. Pallone, Mr. Berry, Ms. Slaughter, Mr. Stupak, Mr. McDermott, Mr. 
  Hinchey, Mr. Frank of Massachusetts, Mr. Oberstar, Mr. Andrews, Mr. 
 Meeks of New York, Mr. Delahunt, Mr. McNulty, Mr. Berman, Mr. Wexler, 
Ms. Woolsey, Ms. Herseth, Mr. McGovern, Mr. Grijalva, Mr. Sanders, Mr. 
  Weiner, Mr. Conyers, Mr. Kucinich, Mr. Kennedy of Rhode Island, Mr. 
 Olver, and Mr. Abercrombie) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
     To amend the Public Health Service Act to expand the scope of 
information required for the data bank on clinical trials of drugs, 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 ``Fair Access to Clinical Trials 
Act''.

SEC. 2. CLINICAL TRIALS DATA BANK.

    (a) In General.--Title IV of the Public Health Service Act (42 
U.S.C. 281 et seq.) is amended--
            (1) in section 402, by striking subsection (j); and
            (2) by inserting after section 402 the following section:

``SEC. 402A. CLINICAL TRIALS DATA BANK.

    ``(a) In General.--
            ``(1) Data bank.--The Secretary, acting through the 
        Director of NIH, shall establish, maintain, and operate a data 
        bank of information on clinical trials (including premarket and 
        postmarket trials) for drugs, biological products, and devices. 
        The activities of the data bank shall be integrated and 
        coordinated with related activities of other agencies of the 
        Department of Health and Human Services, and to the extent 
        practicable, coordinated with other data banks containing 
        similar information.
            ``(2) Consultation.--The Secretary shall establish the data 
        bank after consultation with the Commissioner of Food and 
        Drugs, the directors of the appropriate agencies of the 
        National Institutes of Health (including the National Library 
        of Medicine), and the Director of the Centers for Disease 
        Control and Prevention.
    ``(b) Collection and Dissemination of Information.--
            ``(1) Collection.--In carrying out subsection (a), the 
        Secretary shall collect, catalog, store, and disseminate the 
        information described in such subsection.
            ``(2) Inclusion of submitted information.--All information 
        on clinical trials required in this section to be submitted to 
        the Secretary shall be included in the data bank as soon as 
        practicable after the Secretary receives the information, 
        subject to the provisions of this section.
            ``(3) Dissemination.--The Secretary shall disseminate 
        information in the data bank through information systems, which 
        shall include toll-free telephone communications available to 
        members of the public, to health care providers, and to 
        researchers.
    ``(c) Trials Subject to Requirements.--
            ``(1) Trials of safety and effectiveness.--All clinical 
        trials, whether federally funded or privately funded, conducted 
        to test the safety or effectiveness (including comparative 
        effectiveness) of a drug, biological product, or device 
        (whether clinical trials of approved products or unapproved 
        products) are subject to the requirements of this section, 
        except as provided in paragraph (2).
            ``(2) Exceptions.--The requirements of paragraph (1) do not 
        apply to any of the following:
                    ``(A) A clinical trial to determine the safety of a 
                use of a drug if the trial is designed solely to detect 
                major toxicities in the drug or to investigate 
                pharmacokinetics, except that the requirements of such 
                paragraph do apply if the trial is designed solely to 
                investigate pharmacokinetics in a special population or 
                populations.
                    ``(B) A small clinical trial to determine the 
                feasibility of a device, or a trial to test prototype 
                devices where the primary focus is feasibility.
            ``(3) Certain trials.--The data bank may include 
        information on a clinical trial described in subparagraph (A) 
        or (B) of paragraph (2) with the consent of the responsible 
        person for the trial.
            ``(4) Rule of construction.--This section may not be 
        construed as applying to any classified information (as defined 
        in subsection (l)).
    ``(d) Required Information.--
            ``(1) Registration of trial.--
                    ``(A) In general.--Before commencing a clinical 
                trial that is subject to subsection (c)(1), the 
                responsible person for the trial shall register the 
                trial with the Secretary. Such a registration shall be 
                in such form and be submitted in such manner as the 
                Secretary requires, and shall include the following 
                information:
                            ``(i) The medical condition being studied.
                            ``(ii) A scientific title for the trial 
                        that includes the name of the intervention, the 
                        condition, and the outcome being studied.
                            ``(iii) A statement of whether the trial 
                        has undergone research ethics review. The 
                        statement shall provide the date on which 
                        approval was obtained pursuant to such review, 
                        or shall provide that such review is pending. 
                        In the case of a pending review, when approval 
                        is obtained, the responsible person shall 
                        provide an update that provides the date of the 
                        approval.
                            ``(iv) The anticipated start date for the 
                        trial.
                            ``(v) The purpose of the trial, including a 
                        statement of the interventions and comparisons 
                        involved.
                            ``(vi) The eligibility criteria for 
                        participation in the clinical trial.
                            ``(vii) The funding source or sources of 
                        the trial.
                            ``(viii) A statement that--
                                    ``(I) identifies the product as an 
                                unapproved product or as an approved 
                                product, as applicable; and
                                    ``(II) in the case of an approved 
                                product, identifies the trial as 
                                investigating the approved use of the 
                                product or an unapproved use of the 
                                product, as applicable.
                            ``(ix) The estimated completion date for 
                        the trial. For purposes of this section, the 
                        term `completion date' means the date of the 
                        final collection of data from subjects in the 
                        trial for the outcomes described in clause 
                        (vi).
                            ``(x) A description of the primary and 
                        secondary outcomes to be examined in the trial, 
                        the time at which the primary and secondary 
                        outcomes will be assessed, and the dates and 
                        details of any revisions to such outcomes.
                            ``(xi) A statement of the hypothesis being 
                        tested in the trial.
                            ``(xii) The total number of subjects 
                        anticipated to participate in the trial.
                            ``(xiii) Contact information for the person 
                        to whom scientific inquiries regarding the 
                        trial should be made.
                            ``(xiv) Information on--
                                    ``(I) study design;
                                    ``(II) methods;
                                    ``(III) study phase; and
                                    ``(IV) study type.
                            ``(xv) If the trial will test the 
                        effectiveness of the use of a product with 
                        respect to a serious or life-threatening 
                        disease or condition, the additional 
                        information described in subparagraph (B)(i).
                            ``(xvi) With respect to an individual who 
                        is not an employee of the responsible person 
                        for the trial or of the manufacturer of the 
                        product involved, information on any agreement 
                        that the responsible person or manufacturer has 
                        entered into with such individual that 
                        restricts in any manner the ability of the 
                        individual to--
                                    ``(I) discuss the results of the 
                                trial at a scientific meeting or any 
                                other public or private forum; or
                                    ``(II) publish the results of the 
                                trial, or a description or discussion 
                                of the results of the trial, in a 
                                scientific or academic journal.
                            ``(xvii) After the initial submission of 
                        the registration, periodic updates to reflect 
                        changes to information provided under this 
                        subparagraph. Such updates--
                                    ``(I) shall be provided not less 
                                frequently than once every six months 
                                until information on the results of the 
                                trial is submitted under paragraph 
                                (2)(A) or a waiver is provided under 
                                paragraph (2)(D); and
                                    ``(II) shall identify the dates on 
                                which the changes were made.
                    ``(B) Serious or life-threatening diseases.--
                            ``(i) In general.--For a clinical trial 
                        that will test the effectiveness of the use of 
                        a product with respect to a serious or life-
                        threatening disease or condition, the 
                        additional information referred to in 
                        subparagraph (A)(xv) is the following:
                                    ``(I) A brief summary of the trial, 
                                provided in lay language.
                                    ``(II) A description of the 
                                location of trial sites and the start 
                                date of the trial.
                                    ``(III) A point of contact for 
                                individuals desiring to enroll as 
                                subjects in the trial, including a 
                                single point of contact for all trial 
                                sites.
                                    ``(IV) The status of the trial with 
                                respect to the enrollment of subjects, 
                                stated for the trial in general and for 
                                individual trial sites.
                                    ``(V) Information that may be 
                                available--
                                            ``(aa) under a treatment 
                                        investigational new drug 
                                        application, or a treatment 
                                        investigational device 
                                        exemption, that has been 
                                        submitted to the Secretary 
                                        under section 561(c) of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act (relating to 
                                        expanded access protocols); or
                                            ``(bb) as a Group C cancer 
                                        drug (as defined by the 
                                        National Cancer Institute).
                            ``(ii) Formatting for general public.--The 
                        information provided under clause (i) shall be 
                        in a format that can be readily accessed and 
                        understood by members of the general public, 
                        including patients seeking to enroll as 
                        subjects in clinical trials.
                    ``(C) Labels of approved products.--If a clinical 
                trial registered under subparagraph (A) is 
                investigating an approved product and the label for 
                such product is included on the Internet site of the 
                Food and Drug Administration, the information in the 
                data bank concerning the trial shall include an 
                electronic link to such label for individuals accessing 
                the data bank through the Internet.
                    ``(D) Unique identifier.--The Secretary shall 
                assign to each clinical trial registered under 
                subparagraph (A) a unique identifier for purposes of 
                the data bank. The Secretary shall seek to ensure that 
                such identifiers comply with international standards 
                for identifying clinical trials.
                    ``(E) Modifications regarding required 
                information.--Notwithstanding clauses (i) through (xvi) 
                of subparagraph (A), requirements under such clauses 
                may be modified by the Secretary, and additional 
                requirements for the provision of information in 
                registrations under such subparagraph may be 
                established by the Secretary, in order to ensure the 
                nonmisleading disclosure of important information from 
                clinical trials.
            ``(2) Submission of results of trial.--
                    ``(A) In general.--The responsible person for a 
                clinical trial that is subject to subsection (c)(1) 
                shall provide to the Secretary information described in 
                subparagraph (B) on the results of the trial, subject 
                to subparagraph (D). The information shall be provided 
                in the form of a structured abstract and in such manner 
                as the Secretary may require, in a form not likely to 
                mislead or distort the results.
                    ``(B) Information.--For purposes of subparagraph 
                (A), the information described in this subparagraph on 
                the results of a clinical trial is the following:
                            ``(i) The actual completion date of the 
                        trial and the reasons for any difference from 
                        such actual date and the estimated completion 
                        date submitted pursuant to paragraph 
                        (1)(A)(ix), or, if the trial is terminated 
                        prior to completion, the termination date and 
                        reasons for such termination.
                            ``(ii) Primary and secondary outcomes, 
                        presented succinctly as quantitative data and 
                        as tests of hypotheses.
                            ``(iii) Information on the number and type 
                        of significant adverse events in subjects that 
                        may be associated with the product involved, 
                        including such events for which a causal 
                        relationship has not been established.
                            ``(iv) A citation to each covered article 
                        published in a peer-reviewed scientific or 
                        academic journal. An article published in such 
                        a journal is a covered article for purposes of 
                        this clause if--
                                    ``(I) the article discusses the 
                                results of the trial;
                                    ``(II) the responsible person or 
                                the principal investigator for the 
                                clinical trial contributed to the 
                                article; and
                                    ``(III) MEDLINE includes a citation 
                                to the article.
                            ``(v) A description of the process used to 
                        review the results of the trial, including a 
                        statement about whether the results have been 
                        peer reviewed by reviewers independent of the 
                        sponsor.
                            ``(vi) If the trial is investigating an 
                        unapproved product or an unapproved use of an 
                        approved product, a statement, as appropriate, 
                        displayed prominently at the beginning of 
                        information in the data bank concerning the 
                        trial, that the Food and Drug Administration--
                                    ``(I) is currently reviewing an 
                                application for approval of such 
                                product or use to determine whether the 
                                use is safe and effective;
                                    ``(II) has disapproved an 
                                application for approval of such 
                                product or use;
                                    ``(III) has reviewed an application 
                                for approval of such product or use but 
                                the application was withdrawn prior to 
                                approval or disapproval; or
                                    ``(IV) has not reviewed or approved 
                                such product or use as safe and 
                                effective.
                            ``(vii) If data from the trial has not been 
                        submitted to the Food and Drug Administration, 
                        an explanation of why it has not been 
                        submitted.
                            ``(viii) A statement providing such 
                        information on the protocol for the trial as 
                        may be necessary to evaluate the results of the 
                        trial. Criteria issued by the Secretary under 
                        subsection (k) shall include criteria regarding 
                        information that is required for purposes of 
                        such statements.
                            ``(ix) In the group of subjects receiving 
                        the product, and in each comparison group of 
                        subjects, the percentage of individuals who 
                        ceased participation as subjects and the 
                        reasons for ceasing participation.
                            ``(x) Basic demographic information on 
                        subjects.
                            ``(xi) With respect to an individual who is 
                        not an employee of the responsible person for 
                        the trial or of the manufacturer of the product 
                        involved, information (to the extent not 
                        submitted under paragraph (1)(A)(xvi) on any 
                        agreement that the responsible person or 
                        manufacturer has entered into with such 
                        individual that restricts in any manner the 
                        ability of the individual to--
                                    ``(I) discuss the results of the 
                                trial at a scientific meeting or any 
                                other public or private forum; or
                                    ``(II) publish the results of the 
                                trial, or a description or discussion 
                                of the results of the trial, in a 
                                scientific or academic journal.
                            ``(xii) After the initial submission of 
                        information on the results, periodic updates to 
                        reflect changes in the information submitted 
                        pursuant to this subparagraph. Such updates--
                                    ``(I) shall be provided not less 
                                frequently than once every six months 
                                during the 10-year period beginning on 
                                the date on which information on the 
                                results is due under subparagraph 
                                (C)(i); and
                                    ``(II) shall identify the dates on 
                                which the changes were made.
                    ``(C) Due date for results.--
                            ``(i) In general.--Information required 
                        under subparagraph (A) on the results of a 
                        clinical trial shall be submitted to the 
                        Secretary--
                                    ``(I) not later than one year after 
                                the earlier of--
                                            ``(aa) the estimated 
                                        completion date of the trial, 
                                        as submitted under paragraph 
                                        (1)(A)(ix); or
                                            ``(bb) the actual 
                                        completion date of the trial, 
                                        or the actual date of the 
                                        termination of the trial before 
                                        completion, as applicable; or
                                    ``(II) by such later date as may 
                                apply under an extension under clause 
                                (iii).
                            ``(ii) Reports regarding due date in excess 
                        of three years.--If the due date under clause 
                        (i) for information on the results of a 
                        clinical trial is a date that is more than 
                        three years after the date on which the trial 
                        was registered under paragraph (1)(A), the 
                        following applies:
                                    ``(I) Upon the expiration of such 
                                three-year period, the responsible 
                                person for the trial shall submit to 
                                the Secretary a report that describes 
                                the progress being made toward 
                                submission of the results.
                                    ``(II) For each one-year period 
                                that lapses after the submission of the 
                                report under subclause (I), the 
                                responsible person shall submit to the 
                                Secretary an additional report that 
                                describes such progress, except that no 
                                report is required under this subclause 
                                after such due date.
                            ``(iii) Extensions.--
                                    ``(I) In general.--The Secretary 
                                may provide an extension of the due 
                                date under clause (i)(I) for 
                                information on the results of a 
                                clinical trial if the responsible 
                                person for the trial submits to the 
                                Secretary a written request that 
                                demonstrates good cause for the 
                                extension and provides an estimate of 
                                the date on which information on the 
                                results will be submitted. More than 
                                one such extension may be provided by 
                                the Secretary for the clinical trial 
                                involved.
                                    ``(II) Extensions regarding journal 
                                publication.--
                                            ``(aa) Article under 
                                        consideration for 
                                        publication.--With respect to 
                                        the submission of information 
                                        on the results of a clinical 
                                        trial, the Secretary shall 
                                        under subclause (I) provide an 
                                        extension of 18 months after 
                                        the due date under clause 
                                        (i)(I) (or if such an extension 
                                        previously has been provided, 
                                        18 months beginning upon the 
                                        expiration of the most recent 
                                        extension) if--

                                                    ``(AA) the request 
                                                under such subclause 
                                                demonstrates that an 
                                                article providing the 
                                                information described 
                                                in subparagraph (B) has 
                                                been submitted to a 
                                                peer-reviewed 
                                                scientific or academic 
                                                journal for which 
                                                references are included 
                                                in MEDLINE, and the 
                                                request demonstrates 
                                                that the article is 
                                                being considered by the 
                                                journal for 
                                                publication; and

                                                    ``(BB) such request 
                                                is made before the 
                                                expiration of the one-
                                                year period described 
                                                in clause (i)(I) (or if 
                                                such an extension 
                                                previously has been 
                                                provided, before the 
                                                expiration of the most 
                                                recent extension).

                                            ``(bb) Article accepted for 
                                        publication.--If the 
                                        responsible person for a 
                                        clinical trial has received an 
                                        extension under item (aa) 
                                        regarding the trial, the 
                                        Secretary shall provide an 
                                        additional extension of six 
                                        months, beginning upon the 
                                        expiration of such first 
                                        extension, if the person 
                                        demonstrates to the Secretary, 
                                        before the expiration of the 
                                        first extension, that the 
                                        article involved has been 
                                        accepted for publication by a 
                                        journal referred to in such 
                                        item.
                                            ``(cc) Publication during 
                                        period of extension.--With 
                                        respect to an extension under 
                                        item (aa) or (bb), if during 
                                        the period of extension the 
                                        article involved is published 
                                        in a journal referred to in 
                                        item (aa)--

                                                    ``(AA) the 
                                                extension terminates 
                                                upon publication of the 
                                                article; and

                                                    ``(BB) the due date 
                                                under clause (i) 
                                                regarding the clinical 
                                                trial involved becomes 
                                                the date of such 
                                                publication.

                    ``(D) Waivers regarding results of trial.--With 
                respect to the requirement under subparagraph (A) to 
                submit to the Secretary information on the results of a 
                clinical trial, the Secretary may waive the requirement 
                upon a written request to the Secretary by the 
                responsible person for the trial if the Secretary 
                determines that extraordinary circumstances justify the 
                waiver and that providing the waiver is in the public 
                interest or consistent with the protection of the 
                public health. The Secretary shall ensure that 
                information on each such waiver is included in the data 
                bank.
            ``(3) Updates; tracking of changes in submitted 
        information.--The Secretary shall ensure that updates submitted 
        to the Secretary under paragraphs (1)(A)(xvii) and (2)(B)(xii) 
        do not result in the removal from the data bank of the original 
        submissions or of any preceding updates, and that information 
        in the data bank is presented in a manner that enables users to 
        readily access each original submission and to track the 
        changes made by the updates.
    ``(e) Enforcement.--
            ``(1) Effect of failure to provide information.--In the 
        case of a clinical trial that is subject to subsection (c)(1):
                    ``(A) Subject to paragraph (2), if the Secretary 
                determines that with respect to the trial the 
                responsible person is not in compliance with 
                requirements under subsection (d) to submit information 
                to the Secretary, the following applies:
                            ``(i) Such person is subject to a civil 
                        penalty in accordance with paragraph (3).
                            ``(ii) The person is, during the period of 
                        such noncompliance, ineligible for any award 
                        from the Secretary of a grant, cooperative 
                        agreement, or contract for the conduct of any 
                        trial that is subject to subsection (c)(1), 
                        including all current awards for such trials, 
                        except that such period of ineligibility may 
                        not exceed five years.
                            ``(iii) The person is subject to the 
                        sanction described in paragraph (4) (relating 
                        to the investigational use of products) if the 
                        noncompliance is serious or repeated.
                    ``(B) The submission to the Secretary of 
                information under subsection (d) that is false or 
                misleading constitutes noncompliance for purposes of 
                subparagraph (A).
            ``(2) Procedures regarding noncompliance.--
                    ``(A) Notice of noncompliance.--With respect to a 
                clinical trial that is subject to subsection (c)(1), if 
                the Secretary determines that the responsible person 
                involved has not submitted information to the Secretary 
                in accordance with subsection (d), the Secretary--
                            ``(i) shall transmit to such person a 
                        notice specifying the required information and 
                        stating that the person will be subject to 
                        applicable sanctions referred to in paragraph 
                        (1)(A) if the information is not submitted to 
                        the Secretary within 90 days after the date on 
                        which the notice is transmitted;
                            ``(ii) shall through the notice inform the 
                        person that under subsection (h) the person is 
                        being identified in the data bank as a 
                        noncompliant person; and
                            ``(iii) shall through the notice inform the 
                        person of the provisions of paragraph (8).
                    ``(B) Failure to correct noncompliance.--Upon the 
                expiration of the 90-day period beginning on the date 
                on which the Secretary transmits a notice under 
                subparagraph (A) to a responsible person, the Secretary 
                shall impose on such person the sanctions referred to 
                in clauses (i) and (ii) of paragraph (1)(A) if the 
                information involved has not been submitted to the 
                Secretary, except that the Secretary may elect not to 
                impose such a sanction or sanctions if the Secretary 
                determines that the noncompliance involved is not 
                serious or repeated.
            ``(3) Amount of civil penalty; hearing procedures.--With 
        respect to a civil penalty imposed under paragraph (1)(A)(i) on 
        a responsible person:
                    ``(A) The amount of the penalty shall be not more 
                than a total of $15,000 for all violations adjudicated 
                in a single proceeding in the case of an individual, 
                and not more than $10,000 per day until the violation 
                is corrected in the case of any other person, except 
                that if the person is a nonprofit entity the penalty 
                may not exceed a total of $15,000 for all violations 
                adjudicated in a single proceeding.
                    ``(B) The provisions of paragraphs (3) through (5) 
                of section 303(f) of the Federal Food, Drug, and 
                Cosmetic Act apply to the imposition of such a penalty 
                to the same extent and in the same manner as such 
                provisions apply to a penalty imposed under such 
                section 303(f).
            ``(4) Eligibility for investigational use exemptions.--In 
        any case in which the noncompliance referred to in paragraph 
        (1)(A) is serious or repeated, the Secretary may, upon the 
        expiration of the 90-day period beginning on the date on which 
        the Secretary transmits a notice under paragraph (2)(A) to the 
        responsible person involved, consider such person to be 
        ineligible for any future exemptions under section 505(i) or 
        520(g) of the Federal Food, Drug, and Cosmetic Act for any 
        investigation until the violation is corrected, except that 
        such period of ineligibility may not exceed five years. The 
        Secretary may impose such sanction only after notice and an 
        opportunity for a hearing, unless a hearing regarding such 
        noncompliance is held pursuant to paragraph (3) and through 
        such hearing the Secretary determines that the noncompliance 
        was serious or repeated.
            ``(5) Failure to submit information on results; requirement 
        of reports.--In any case in which the noncompliance referred to 
        in paragraph (1)(A) is a failure to submit to the Secretary 
        information on the results of the trial by the due date under 
        subsection (d)(2)(C)(i), the Secretary shall order the 
        responsible person to submit to the Secretary periodic reports 
        on the progress being made toward submission of information on 
        the results, which reports shall be submitted not less 
        frequently that once each year until the information is 
        submitted to the Secretary.
            ``(6) Rule of construction.--With respect to a responsible 
        person who is subject to a sanction referred to in paragraph 
        (1)(A), this subsection may not be construed as providing that 
        any other person associated with the clinical trial involved is 
        subject to the sanction.
            ``(7) Use of funds.--
                    ``(A) In general.--The Secretary shall deposit the 
                funds collected under paragraph (1)(A) into an account 
                and use such funds, in consultation with the Director 
                of the Agency for Healthcare Research and Quality, to 
                fund studies that compare the clinical effectiveness of 
                two or more treatments for a disease or condition.
                    ``(B) Funding decisions.--The Secretary shall award 
                funding under subparagraph (A) based on a priority list 
                established not later than six months after the date of 
                enactment of the Fair Access to Clinical Trials Act by 
                the Director of the Agency for Healthcare Research and 
                Quality and periodically updated as determined 
                appropriate by the Director.
            ``(8) Disclosure of certain information.--In the case of a 
        responsible person to whom a notice under paragraph (2) has 
        been transmitted, if such person has not submitted the 
        information involved to the Secretary by the expiration of the 
        180-day period beginning on the date on which the notice was 
        transmitted to the person, the following applies:
                    ``(A) Notwithstanding section 301(j) of the Federal 
                Food, Drug, and Cosmetic Act, section 1905 of title 18, 
                United States Code, subsection (j)(4)(C)(ii) of this 
                section, or any other provision of law, the Secretary 
                shall begin disclosure through the data bank of the 
                definitions of the primary and secondary outcomes for 
                the clinical trial involved unless the definitions have 
                already been disclosed pursuant to subsection 
                (j)(4)(C)(ii).
                    ``(B) Notwithstanding section 301(j) of the Federal 
                Food, Drug, and Cosmetic Act, section 1905 of title 18, 
                United States Code, or any other provision of law, if 
                the responsible person is the manufacturer or a 
                distributor of the product involved, the Secretary 
                shall through the data bank disclose information on the 
                product that--
                            ``(i) is required to be submitted under 
                        subsection (d); and
                            ``(ii) is included in any FDA application 
                        for the product (as defined in subsection (l)) 
                        that the responsible person has submitted to 
                        the Secretary.
    ``(f) Trials Conducted Outside United States.--
            ``(1) In general.--If a covered person submits to the 
        Secretary an FDA application for a product (as defined in 
        subsection (l)), and one or more of the investigations 
        presented to the Secretary by such person for purposes of the 
        document are covered foreign investigations, the person is 
        subject to a civil penalty--
                    ``(A) in any case in which information on the 
                investigation has not, as of the date on which the 
                application is submitted to the Secretary, been 
                submitted to the data bank to the same extent as would 
                have been required as of such date under subsection (d) 
                if the investigation had been subject to subsection 
                (c)(1); and
                    ``(B) in any case in which, after such date, 
                information on the investigation is not submitted to 
                the data bank to the same extent as would be required 
                if the investigation were subject to subsection (c)(1).
            ``(2) Procedures.--The provisions of paragraphs (2), (3), 
        (6), and (7) of subsection (e) apply to a civil penalty under 
        paragraph (1) to the same extent and in the same manner as such 
        provisions apply to a civil penalty under subsection (e)(1)(A).
            ``(3) Definitions.--With respect to an FDA application for 
        a product, for purposes of this subsection:
                    ``(A) The term `covered foreign investigation' 
                means an investigation that was not conducted in any of 
                the States and was not subject to subsection (c)(1).
                    ``(B) The term `covered person' means the person 
                who was the principal investigator or the responsible 
                person for any of the covered foreign investigation or 
                investigations involved.
    ``(g) Labeling and Advertisements.---
            ``(1) In general.--If a person disseminates labeling, or an 
        advertisement or other descriptive printed matter, for an 
        approved product for human use and the labeling, advertisement, 
        or other matter refers to an investigation that is not subject 
        to subsection (c)(1), and if the person was the principal 
        investigator or the responsible person for the investigation, 
        the person is subject to a civil penalty--
                    ``(A) in any case in which information on the 
                investigation has not, as of the date on which the 
                labeling, advertisement, or other matter enters the 
                market, been submitted to the data bank to the same 
                extent as would have been required as of such date 
                under subsection (d) if the investigation had been 
                subject to subsection (c)(1); and
                    ``(B) in any case in which, after such date, 
                information on the investigation is not submitted to 
                the data bank to the same extent as would be required 
                if the investigation were subject to subsection (c)(1).
            ``(2) Procedures.--The provisions of paragraphs (2), (3), 
        (6), and (7) of subsection (e) apply to a civil penalty under 
        paragraph (1) to the same extent and in the same manner as such 
        provisions apply to a civil penalty under subsection (e)(1)(A).
    ``(h) Public List of Noncompliant Responsible Persons.--In any case 
in which a notice of noncompliance is submitted to a person under 
subsection (e)(2)(A), (f)(2), or (g)(2), the Secretary shall include 
with the information in the data bank that concerns the clinical trial 
involved a statement, prominently displayed, that such person has not 
reported information to the data bank as required by law, which 
statement shall remain in the data bank until the information involved 
is submitted to the Secretary. For purposes of the preceding sentence, 
the Secretary shall maintain a list of noncompliant persons that is 
available to the public.
    ``(i) Compliance Audits.--
            ``(1) In general.--The Secretary shall conduct periodic 
        audits of responsible persons for clinical trials that are 
        subject to subsection (c)(1) in order to determine whether such 
        persons have submitted information as required in subsection 
        (d), including determining whether any of the information is 
        false or misleading.
            ``(2) Priority.--In conducting audits under subparagraph 
        (A), the Secretary shall give priority to responsible persons 
        for clinical trials who have at any time been included on the 
        list under subsection (h), taking into account the number and 
        severity of the violations involved.
    ``(j) General Provisions.--
            ``(1) Authority of secretary.--
                    ``(A) Inclusion of statements to avoid 
                misinterpretations.--The Secretary may include in the 
                data bank such statements as the Secretary determines 
                to be appropriate to assist the public in avoiding 
                misinterpretations of information in the data bank. 
                Statements under the preceding sentence may include 
                statements regarding the data bank in general and 
                statements regarding particular items of information 
                submitted to the data bank. The Secretary may not under 
                the preceding sentence alter any information as 
                submitted.
                    ``(B) False or misleading information.--If the 
                Secretary determines that information presented or 
                cited in the data bank is false or misleading, the 
                Secretary shall, promptly after making such 
                determination, identify in the data bank the 
                information as false or misleading (as applicable), and 
                shall, to the extent practicable, include in the data 
                bank an accurate version of the information. The 
                Secretary shall in addition make appropriate public 
                notification.
            ``(2) Limitation on disclosures.--This section may not be 
        construed as authorizing the disclosure of information through 
        the data bank if--
                    ``(A) such disclosure would constitute a clearly 
                unwarranted invasion of personal privacy; or
                    ``(B) such information concerns a method or process 
                which as a trade secret is entitled to protection 
                within the meaning of section 301(j) of the Federal 
                Food, Drug, and Cosmetic Act.
            ``(3) Institutional review boards.--The Secretary shall 
        amend part 46 of title 45, Code of Federal Regulations, and 
        parts 50, 56, and 812 of title 21 of Code, to provide as 
        follows:
                    ``(A) That the functions of institutional review 
                boards under such parts include--
                            ``(i) determining whether clinical trials 
                        that are subject to subsection (c)(1) are 
                        registered under subsection (d)(1)(A); and
                            ``(ii) denying the approval of the boards 
                        for such trials that are not so registered.
                    ``(B) That any approval of an institutional review 
                board regarding such a trial is not effective under 
                such parts if the trial is not so registered.
                    ``(C) That upon request of an institutional review 
                board for such a trial, the Secretary will provide to 
                the board a copy of the registration for the trial 
                under subsection (d)(1)(A) (which copy will be the 
                registration as submitted to the Secretary, together 
                with all updates to the registration).
            ``(4) Disclosure of information.--
                    ``(A) In general.--The Secretary shall disseminate 
                information in the data bank through an Internet site 
                or sites under subparagraph (B) and through any other 
                means determined appropriate by the Secretary. 
                Information required in this section to be submitted to 
                the Secretary shall not be considered confidential 
                commercial information or trade secrets, 
                notwithstanding any other provision of law.
                    ``(B) Internet sites.--
                            ``(i) In general.--The Secretary shall 
                        operate one or more searchable Internet sites 
                        for purposes of presenting to clinicians and 
                        researchers, and to patients seeking to enroll 
                        as subjects in clinical trials, information in 
                        the data bank. The Secretary shall ensure 
                        that--
                                    ``(I) such a site, or a portion of 
                                a site, is designed specifically for 
                                use by clinicians and researchers; and
                                    ``(II) such a site, or a portion of 
                                a site, is designed specifically for 
                                use by patients seeking to enroll as 
                                subjects in clinical trials.
                            ``(ii) Relation to certain internet site.--
                        The Secretary shall ensure that the Internet 
                        site or portion thereof operated under clause 
                        (i)(II) includes information of the type that 
                        was available on ClinicalTrials.gov as of the 
                        day before the date of the enactment of the 
                        Fair Access to Clinical Trials Act (relating to 
                        serious or life-threatening diseases). This 
                        section may not be construed as requiring the 
                        Secretary to terminate or alter 
                        ClinicalTrials.gov, or as prohibiting the 
                        Secretary from terminating or altering such 
                        site.
                    ``(C) Registration information; date of 
                disclosure.--In the case of information regarding a 
                clinical trial that is submitted to the Secretary under 
                subsection (d)(1), disclosures of the information 
                through the data bank shall, subject to subsection 
                (e)(8), begin in accordance with the following:
                            ``(i) All such disclosures shall begin 
                        promptly after the registration involved is 
                        submitted to the Secretary, other than 
                        disclosure of the definitions of the primary 
                        and secondary outcomes.
                            ``(ii) Disclosure of the definition of the 
                        primary and secondary outcomes shall begin at 
                        the same time as disclosure of the results of 
                        the trial begin under subparagraph (D)(i), 
                        unless the responsible person for the trial 
                        requests earlier disclosure, or unless the 
                        Secretary requires earlier disclosure pursuant 
                        to subparagraph (E)(ii).
                    ``(D) Results of trial; date of disclosure.--
                            ``(i) In general.--In the case of 
                        information regarding a clinical trial that is 
                        submitted to the Secretary under subsection 
                        (d)(2)(A), disclosures of the information 
                        through the data bank shall begin promptly 
                        after the information is submitted to the 
                        Secretary, subject to clause (ii).
                            ``(ii) Waiver regarding results of trial.--
                        In the case of information on waivers that is 
                        contained in the data bank under subsection 
                        (d)(2)(D), disclosures of the information 
                        through the data bank shall begin promptly 
                        after the waiver is provided.
                    ``(E) Study regarding date for disclosure of 
                primary and secondary outcomes; authority of 
                secretary.--
                            ``(i) In general.--The Secretary, in 
                        consultation with appropriate government 
                        agencies, shall conduct a study to determine 
                        whether the delay in disclosure of the 
                        definitions of the primary and secondary 
                        outcomes under clause (ii) of subparagraph (C), 
                        relative to the timing of disclosures under 
                        clause (i) of such subparagraph, is consistent 
                        with the protection of the public health. Not 
                        later than three years after the date of the 
                        enactment of the Fair Access to Clinical Trials 
                        Act, the Secretary shall complete the study and 
                        submit to the appropriate committees of the 
                        Congress a report describing the findings of 
                        the study.
                            ``(ii) Authority of secretary.--If on the 
                        basis of the study under clause (i) the 
                        Secretary determines that the delay referred to 
                        in such clause is not consistent with the 
                        protection of the public health, the Secretary 
                        shall by regulation establish an earlier date 
                        for disclosures of the definitions referred to 
                        in such clause, which date may not be earlier 
                        than the date of disclosures under subparagraph 
                        (C)(i). A final rule shall be issued under the 
                        preceding sentence not later than one year 
                        after the date on which the report under clause 
                        (i) of this subparagraph is submitted to the 
                        appropriate committees of the Congress.
            ``(5) Limitation on use of information.--Information on a 
        clinical trial that is disclosed through the data bank, 
        including information disclosed under subsection (e)(8), may 
        not be used by a person other than the responsible person for 
        the trial (or an entity acting with the permission of such 
        person) as part of any FDA application (as defined in 
        subsection (l)) unless the information is available in 
        accordance with law from a source other than the data bank.
            ``(6) Submission format and technical standards.--
                    ``(A) In general.--The Secretary shall, to the 
                extent practicable, accept submissions required in 
                subsection (d) in an electronic format and shall 
                establish interoperable technical standards for such 
                submissions.
                    ``(B) Consistency of standards.--To the extent 
                practicable, the standards established under 
                subparagraph (A) shall be consistent with standards 
                adopted by the Consolidated Health Informatics 
                Initiative (or a successor organization to such 
                Initiative) to the extent such Initiative (or 
                successor) is in operation.
            ``(7) Trials not involving drugs, biological products, or 
        devices.--The Secretary shall establish procedures and 
        mechanisms to allow for the voluntary submission to the 
        Secretary of information described in subsection (d)(2)(B) on 
        clinical trials that are not subject to subsection (c)(1). 
        Information received by the Secretary under this paragraph 
        shall be included in the data bank. In any case in which it is 
        in the interest of public health, the Secretary may require 
        that information on such trials be submitted to the Secretary. 
        Failure to comply with such a requirement shall be deemed to be 
        a failure to submit information as required under this section, 
        and the appropriate remedies and sanctions under this section 
        shall apply.
            ``(8) Award for conduct of clinical trial; compliance costs 
        as direct costs.--In administering an award of a grant, 
        contract, or cooperative agreement that is subject to 
        subsection (c)(1), the Secretary shall consider the costs of 
        complying with requirements under this section as part of the 
        direct costs of conducting the clinical trial involved.
    ``(k) Criteria.--The Secretary shall establish criteria regarding 
compliance with this section.
    ``(l) Definitions.--For purposes of this section:
            ``(1) The term `approved product' means a product that is 
        approved, licensed, or cleared for commercial distribution 
        under section 505, 510(k), or 515 of the Federal Food, Drug, 
        and Cosmetic Act or under section 351 of this Act.
            ``(2) The term `approved use', with respect to an approved 
        product, means a use that is an approved, licensed, or cleared 
        use of the product under a provision of law referred to in 
        paragraph (1).
            ``(3) The term `biological product' has the meaning given 
        such term in section 351.
            ``(4) The term `classified', with respect to information, 
        means information on matters referred to in section 
        552(b)(1)(A) of title 5, United States Code.
            ``(5) The term `clinical trial', with respect to a product, 
        means a clinical investigation within the meaning of section 
        505(i) of the Federal Food, Drug, and Cosmetic Act (in the case 
        of drug), or within the meaning of section 520(g) of such Act 
        (in the case of a device), as applicable, except that such term 
        does not include such an investigation that does not 
        prospectively assign human subjects to intervention or 
        comparison groups to study the causal relationship between a 
        medical intervention and an outcome.
            ``(6) The term `data bank' means the data bank under 
        subsection (a).
            ``(7) The term `device' has the meaning given such term in 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act.
            ``(8) The term `drug' has the meaning given such term in 
        section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act. 
        Such term includes a biological product.
            ``(9) The term `FDA application', with respect to a 
        product, means each of the following:
                    ``(A) An application or report submitted to the 
                Secretary for the purpose of seeking a decision by the 
                Secretary for the product to become an approved product 
                (as defined in paragraph (1)). Such term includes a 
                supplement to such an application or report.
                    ``(B) An application for an exemption under section 
                505(i) or 520(g) of the Federal Food, Drug, and 
                Cosmetic Act (relating to investigational use).
            ``(10) The term `MEDLINE' means the bibliographic 
        electronic data base of references to journal-published 
        articles that is operated by the National Library of Medicine 
        and is designated by such Library as the Medical Literature, 
        Analysis, and Retrieval System Online.
            ``(11) The term `postmarket', with respect to a clinical 
        trial to investigate a product, means a clinical trial that is 
        conducted after the product has become an approved product.
            ``(12) The term `product' means a drug, biological product, 
        or device.
            ``(13) The term `responsible person', with respect to a 
        clinical trial that is subject to subsection (c)(1), has the 
        following meaning, as applicable:
                    ``(A) In any case in which an application has with 
                respect to the trial been submitted for an exemption 
                under section 505(i) or 520(g)(2)(A) of the Federal 
                Food, Drug, and Cosmetic Act, such term means the 
                entity who, within the meaning of such section, is the 
                sponsor of the trial.
                    ``(B) In any case in which such an application has 
                not been submitted, such term means the entity who is 
                or will be providing the largest share of the monetary 
                support for the trial (without regard to any in-kind 
                support for the trial), subject to the following:
                            ``(i) If the Federal Government or a State 
                        is or will be providing the largest share, such 
                        term means the principal investigator for the 
                        trial.
                            ``(ii) If a nonprofit private entity is or 
                        will be providing the largest share, such term 
                        means the principal investigator for the trial 
                        in any case in which such entity and 
                        investigator have jointly certified to the 
                        Secretary that the investigator will be the 
                        responsible person for purposes of this 
                        section.
                            ``(iii) If two or more entities provide 
                        equal monetary support for the trial and no 
                        other entity provides a greater amount of 
                        monetary support, such term means each of the 
                        entities providing such equal support, other 
                        than the Federal Government or a State.
                            ``(iv) Notwithstanding clauses (i) through 
                        (iii), if an entity submits to the Secretary a 
                        written request to be the responsible person 
                        for purposes of this section, such term means 
                        that entity in any case in which the Secretary 
                        determines that the entity is responsible for 
                        conducting the trial, has access to and control 
                        over the data, has the right to publish the 
                        results of the trial, and has the 
                        responsibility to meet all of the requirements 
                        under this section that are applicable to 
                        responsible persons.
            ``(14) The term `unapproved product' means a product that 
        is not an approved product.
            ``(15) The term `unapproved use', with respect to an 
        approved product, means a use that is not an approved use.
    ``(m) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for fiscal year 2005 and each subsequent fiscal year. 
Fees collected under section 736 or 738 of the Federal Food, Drug, and 
Cosmetic Act shall not be used in carrying out this section.''.
    (b) Applicability.--With respect to section 402A of the Public 
Health Service Act (as added by subsection (a) of this section):
            (1) Subject to paragraphs (2) and (3), such section 402A 
        applies to all clinical trials that are commenced on or after 
        the date of the enactment of this Act, or are in progress as of 
        such date, to the extent the trials are described in subsection 
        (c)(1) of such section and not within an exception under 
        subsection (c)(2) of such section.
            (2) For purposes of paragraph (1), such section 402A 
        applies to a trial that is in progress only if the final data 
        collection from subjects in the trial on the primary outcome 
        has not been completed as of the date of the enactment of this 
        Act. Such a trial becomes subject to such section upon the 
        expiration of 30 days after such date of enactment, except that 
        registration information required pursuant to subsection (d)(1) 
        of such section is due upon the expiration of such 30 days.
            (3) The Secretary of Health and Human Services (referred to 
        in this paragraph as the ``Secretary'') shall establish 
        procedures and mechanisms to allow for the voluntary submission 
        to the Secretary of information described in subsection 
        (d)(2)(B) of such section 402A on clinical trials that were 
        completed prior to such date of enactment, or were in progress 
        as of such date but not subject to paragraph (2). Information 
        received by the Secretary under this paragraph shall be 
        included in the data bank. In any case in which it is in the 
        interest of public health, the Secretary may require that 
        information on such trials be submitted to the Secretary. 
        Failure to comply with such a requirement shall be deemed to be 
        a failure to submit information as required under such section, 
        and the appropriate remedies and sanctions under such section 
        shall apply.
            (4) Definitions applicable to such section 402A apply for 
        purposes of this subsection.
    (c) Rule of Construction Regarding Prior Provision.--With respect 
to the data bank program under section 402(j) of the Public Health 
Service Act as in effect on the day before the date of the enactment of 
this Act:
            (1) Subsection (a) shall be construed as a transfer and 
        modification of the program, and not as the termination of the 
        program and the establishment of a different program.
            (2) All information contained in the data bank on such day 
        shall continue to be contained in the data bank, subject to 
        section 402A of the Public Health Service Act (as added by 
        subsection (a) of this section) or other applicable provisions 
        of law.
    (d) Conforming Amendments.--Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended--
            (1) in section 505(i), by adding at the end the following 
        paragraph:
    ``(5) The provision of an exemption under paragraph (1) is subject 
to section 402A(e)(4) of the Public Health Service Act (relating to a 
data bank on clinical trials).''; and
            (2) in section 520(g), by adding at the end the following 
        paragraph:
    ``(8) The provision of an exemption under paragraph (2)(A) is 
subject to section 402A(e)(4) of the Public Health Service Act 
(relating to a data bank on clinical trials).''.

SEC. 3. REPORTS.

    (a) Implementation Report.--Not later than one year after the date 
of enactment of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall submit to the 
appropriate committees of the Congress a report on the status of the 
implementation of the requirements of the amendments made by section 2 
that includes a description of the number and types of clinical trials 
for which information has been submitted under such amendments.
    (b) Data Collection.--
            (1) In general.--The Secretary shall request the Institute 
        of Medicine to enter into a contract with the Secretary for the 
        conduct of a study concerning the extent to which information 
        submitted to the data bank under section 402A of the Public 
        Health Service Act (as added by section 2(a)) has impacted the 
        public health.
            (2) Report.--The Secretary shall ensure that the contract 
        under paragraph (1) provides that, not later than six months 
        after the date on which a contract is entered into, the 
        Institute of Medicine will submit to the Secretary a report on 
        the results of the study under such paragraph, and that the 
        report may include any recommendations of the Institute for 
        changes to the program carried out under the section referred 
        to in such paragraph that the Institute considers appropriate 
        to benefit the public health.
                                 <all>
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