[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5252 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 5252

To amend the Public Health Service Act and the Federal Food, Drug, and 
    Cosmetic Act with respect to the availability to the public of 
      information on clinical trials to determine the safety and 
effectiveness of drugs, biological products, and devices, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 7, 2004

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

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act and the Federal Food, Drug, and 
    Cosmetic Act with respect to the availability to the public of 
      information on clinical trials to determine the safety and 
effectiveness of drugs, biological products, and devices, 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. REGISTRATION OF CLINICAL TRIALS UNDER PUBLIC HEALTH SERVICE 
              ACT.

    (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 491 the following section:

``SEC. 491A. REGISTRATION OF CLINICAL TRIALS; DATA BANK.

    ``(a) In General.--
            ``(1) Conditions for financial awards.--Except as provided 
        in paragraph (2), an entity may not receive an award of a 
        grant, contract, or cooperative agreement under this Act for 
        the conduct of a clinical trial to determine the safety or 
        effectiveness of a use of a drug or device (referred to in this 
        section as a `product') unless the responsible person for the 
        trial--
                    ``(A) agrees to register the trial with the 
                Secretary in accordance with subsection (d)(1);
                    ``(B) agrees to provide to the Secretary 
                information on the results of the trial in accordance 
                with subsection (d)(2);
                    ``(C) agrees to the disclosure to the public of 
                information regarding the trial in accordance with 
                subsection (e); and
                    ``(D) agrees to be subject to audits under 
                subsection (f)(1), and as applicable, to liquidated 
                penalties and the requirement to submit reports under 
                subsection (g)(1).
            ``(2) Exception.--Paragraph (1) does not apply to 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 such 
        paragraph does apply if the trial is designed solely to 
        investigate pharmacokinetics in a special population or 
        populations.
    ``(b) Data Bank.--
            ``(1) In general.-- The Secretary, acting through the 
        Director of NIH, shall establish, maintain, and operate a data 
        bank of information provided to the Secretary pursuant to 
        subsection (a), including collecting, cataloging, and storing 
        the information, and disseminating the information in 
        accordance with subsection (e). 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) Information from elective submissions.--
                    ``(A) Clinical trials regarding drugs or devices.--
                The Secretary may accept for inclusion in the data bank 
                information on clinical trials that are trials to 
                determine the safety or effectiveness of a use of a 
                product but are not subject to requirements under 
                subsection (a). The inclusion of information in the 
                data bank under the preceding sentence is subject to 
                the condition that the responsible person for the 
                clinical trial involved make each of the agreements 
                described in subsection (a)(1).
                    ``(B) Other clinical trials.--The Secretary may 
                accept for inclusion in the data bank information on 
                clinical trials that do not involve drugs or devices if 
                the responsible person for the trial involved agrees to 
                such conditions regarding the submission and disclosure 
                of the information as the Secretary determines to be 
                appropriate, taking into account the requirements of 
                this section for clinical trials that do involve drugs 
                or devices.
            ``(3) Consultation.--The Secretary shall operate the data 
        bank in consultation with the Commissioner of Food and Drugs, 
        the directors of the appropriate agencies of the National 
        Institutes of Health, and the Director of the Centers for 
        Disease Control and Prevention.
            ``(4) National library of medicine.--The Director of NIH 
        shall assign to the National Library of Medicine the primary 
        responsibility for carrying out paragraph (1).
            ``(5) Entry of information.--Information provided to the 
        Secretary under this section by responsible persons for 
        clinical trials shall be entered in the data bank promptly 
        after the Secretary receives the information, except to the 
        extent that the Secretary determines that the information has 
        not been submitted to the Secretary in accordance with this 
        section, in which case the Secretary shall promptly inform the 
        responsible person involved that corrective actions by the 
        person are necessary to maintain compliance with this section.
            ``(6) 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.--
                            ``(i) In general.--If under subsection (f) 
                        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.
                            ``(ii) Limitation.--Clause (i) does not 
                        authorize the disclosure of information if--
                                    ``(I) the disclosure would 
                                constitute a clearly unwarranted 
                                invasion of personal privacy; or
                                    ``(II) the information concerns a 
                                method or process that is a trade 
                                secret entitled to protection within 
                                the meaning of section 301(j) of the 
                                Federal Food, Drug, and Cosmetic Act.
    ``(c) Institutional Review Boards.--For purposes of subsection (a), 
the Secretary shall amend part 46 of title 45, Code of Federal 
Regulations, to provide that--
            ``(1) the functions of institutional review boards under 
        such part include--
                    ``(A) determining whether clinical trials to 
                determine the safety or effectiveness of products are 
                registered under subsection (a)(1)(A); and
                    ``(B) denying the approval of the boards for such 
                trials that are not registered under such subsection;
            ``(2) any approval of an institutional review board 
        regarding such a trial is not effective under such part if the 
        trial is not registered under such subsection; and
            ``(3) 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 such subsection (which 
        copy will be the registration as submitted to the Secretary, 
        together with all updates to the registration).
    ``(d) Submission of Required Information.--
            ``(1) Submission of registration information.--
                    ``(A) In general.--A registration of a clinical 
                trial under subsection (a)(1)(A) is in accordance with 
                this paragraph if, subject to subparagraph (B), the 
                registration is in such form and is submitted in such 
                manner as the Secretary requires, and the registration 
                contains such information on the design and goals of 
                the trial as the Secretary determines to be important 
                to clinicians or researchers. Such information shall 
                include the following:
                            ``(i) A brief title for the trial, provided 
                        in lay language.
                            ``(ii) The disease or condition with which 
                        the trial is concerned.
                            ``(iii) The medical intervention or 
                        interventions being investigated in the trial.
                            ``(iv) A statement that--
                                    ``(I) identifies the product as an 
                                unapproved product or as an approved 
                                product, as applicable; and
                                    ``(II) in addition, 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.
                            ``(v) The purpose of the trial, including a 
                        statement of the interventions and comparisons 
                        involved.
                            ``(vi) A statement of the hypothesis being 
                        tested in the trial.
                            ``(vii) Information on--
                                    ``(I) study design;
                                    ``(II) methods;
                                    ``(III) study phase; and
                                    ``(IV) study type.
                            ``(viii) The definition of the primary and 
                        secondary outcomes for the trial.
                            ``(ix) The length of time for which data on 
                        the primary and secondary outcomes will be 
                        collected on each patient.
                            ``(x) Eligibility criteria for 
                        participation in the trial.
                            ``(xi) The total number of subjects 
                        anticipated to participate in the trial.
                            ``(xii) The anticipated or actual date on 
                        which the trial will begin.
                            ``(xiii) The anticipated or actual date of 
                        final data collection from subjects in the 
                        trial on the primary outcome.
                            ``(xiv) The identity of each responsible 
                        person for the trial.
                            ``(xv) Sources of funding for the trial in 
                        addition to the award under this Act.
                            ``(xvi) The identity of the principal 
                        investigator in the trial.
                            ``(xvii) Contact information for the 
                        principal investigator.
                            ``(xviii) A unique protocol number 
                        identification number for the trial, which 
                        number shall be assigned by the Secretary.
                            ``(xix) After the initial submission of the 
                        registration, periodic updates to reflect 
                        changes to information provided under this 
                        subparagraph and subparagraph (B), which 
                        updates--
                                    ``(I) are provided not less 
                                frequently than once every six months 
                                until the results of the trial are 
                                submitted under paragraph (2)(A)(i) or 
                                a waiver is provided under paragraph 
                                (2)(C); and
                                    ``(II) identify the dates on which 
                                the changes were made.
                    ``(B) Serious or life-threatening diseases; test of 
                effectiveness.--In the case of a registration under 
                subsection (a)(1)(A) of a clinical trial to test the 
                effectiveness of the use of a product with respect to a 
                serious or life-threatening disease or condition, the 
                registration is in accordance with this paragraph if, 
                in addition to the information described in 
                subparagraph (A), the registration provides the 
                following information:
                            ``(i) A brief summary of the trial, 
                        provided in lay language.
                            ``(ii) A description of the location of 
                        trial sites.
                            ``(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--
                                    ``(I) 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
                                    ``(II) as a Group C cancer drug (as 
                                defined by the National Cancer 
                                Institute).
            ``(2) Submission of results of trial.--
                    ``(A) In general.--For purposes of subsection 
                (a)(1)(B), information on the results of a clinical 
                trial is provided in accordance with this paragraph if, 
                subject to subparagraphs (B) and (C), the following 
                conditions are met:
                            ``(i) The results are submitted--
                                    ``(I) not later than 12 months 
                                after the earlier of the anticipated 
                                date that applies under paragraph 
                                (1)(A)(xiii) or the actual date that 
                                applies under such paragraph; or
                                    ``(II) such later date as may apply 
                                under an extension under subparagraph 
                                (B).
                            ``(ii) The results are provided in the form 
                        of a structured abstract and in such manner as 
                        the Secretary may require.
                            ``(iii) The results consist of information 
                        determined by the Secretary to be important to 
                        clinicians or researchers, in a form that 
                        ensures that the information is accurate and 
                        not likely to mislead or distort the results of 
                        the trial. Such information shall include the 
                        following:
                                    ``(I) The date on which the trial 
                                commenced.
                                    ``(II) The actual date for the 
                                final collection of data from subjects 
                                in the trial.
                                    ``(III) Primary and secondary 
                                outcomes, presented succinctly as 
                                quantitative data and as tests of 
                                hypotheses.
                                    ``(IV) Basic demographic 
                                information on subjects.
                                    ``(V) In the group of subjects 
                                receiving the product, and in each 
                                comparison group of subjects, the 
                                percentage of individuals who decided 
                                to cease participation as subjects and 
                                the reasons for ceasing participation.
                                    ``(VI) Information on 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) If the trial is investigating an 
                        unapproved use of an approved product, a 
                        statement is submitted to the data bank that 
                        the Food and Drug Administration, as 
                        applicable--
                                    ``(I) is currently reviewing an 
                                application for approval of the 
                                unapproved use;
                                    ``(II) has disapproved such an 
                                application;
                                    ``(III) has reviewed such an 
                                application, but the application was 
                                withdrawn prior to approval or 
                                disapproval; or
                                    ``(IV) has not reviewed or approved 
                                such an application.
                            ``(v) After the initial submission of the 
                        results, periodic updates are submitted to the 
                        data bank to reflect changes in the information 
                        submitted under this subparagraph, which 
                        updates--
                                    ``(I) are provided not less 
                                frequently than once every six months 
                                during the 10-year period beginning on 
                                the date on which the results are due 
                                under clause (i); and
                                    ``(II) identify the dates on which 
                                the changes were made.
                            ``(vi) For each covered article published 
                        in a peer-reviewed scientific or academic 
                        journal, the responsible person for the trial 
                        submits to the data bank a statement that 
                        provides a citation to the article. 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.
                            ``(vii) If the due date under clause (i) 
                        for the trial is a date that is more than three 
                        years after the date on which the trial was 
                        registered under subsection (a)(1)(A):
                                    ``(I) Upon the expiration of such 
                                three-year period, the responsible 
                                person for the trial submits to the 
                                data bank a report that describes the 
                                progress being made toward submission 
                                of the results.
                                    ``(II) For each two-year period 
                                that lapses after the submission of the 
                                report under subclause (I), the 
                                responsible person submits to the data 
                                bank an additional report that 
                                describes such progress, except that no 
                                report is required under this subclause 
                                after such due date.
                    ``(B) Extensions.--
                            ``(i) In general.--The Secretary may 
                        provide an extension of the due date under 
                        subparagraph (A)(i) for 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 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.--
                                    ``(I) Article under consideration 
                                for publication.--The Secretary shall 
                                under clause (i) provide an extension 
                                of 18 months regarding the submission 
                                of the results of a clinical trial if--
                                            ``(aa) the request under 
                                        such clause demonstrates that 
                                        an article providing the 
                                        information described in 
                                        subparagraph (A)(iii) 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 
                                        12-month period described in 
                                        subparagraph (A)(i).
                                    ``(II) Article accepted for 
                                publication.--If the responsible person 
                                for a clinical trial has received an 
                                extension under subclause (I) for 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 subclause.
                    ``(C) Waivers regarding results of trial.--With 
                respect to the requirement under subsection (a)(1)(B) 
                to submit to the Secretary 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) Tracking of changes in information submitted to data 
        bank.--The Secretary shall ensure that updates to the data bank 
        submitted under paragraphs (1)(A)(xviii) and (2)(A)(v) 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) Public Disclosure of Information.--
            ``(1) In general.--The Secretary shall disseminate 
        information in the data bank through information systems in 
        accordance with this subsection. Information required in this 
        section to be submitted to the data bank shall not be 
        considered confidential commercial information or trade 
        secrets, notwithstanding any other provision of law.
            ``(2) Prohibition against fees.-- The Secretary may not 
        impose a fee for providing access to information in the data 
        bank.
            ``(3) Internet sites.--
                    ``(A) 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 that is required 
                in paragraph (5) to be disclosed. 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.
                    ``(B) Relation to certain internet site.--The 
                Secretary shall ensure that the Internet site or 
                portion thereof operated under subparagraph (A)(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.
            ``(4) Specific means of disclosure.--With respect to 
        information in the data bank that is required in paragraph (5) 
        to be disclosed, all disclosures shall be made through an 
        Internet site or sites under paragraph (3) and any other means 
        determined appropriate by the Secretary, except that in the 
        case of information of the type referred to in paragraph (3)(B) 
        and intended for patients seeking to enroll as subjects in 
        clinical trials, the means of disclosure shall include toll-
        free telephone communications.
            ``(5) Required disclosures; authority of secretary for 
        exclusions.--
                    ``(A) Clinicians and researchers.--With respect to 
                means of disclosure under this subsection that are 
                intended for clinicians and researchers, the Secretary 
                shall through such means disclose all information in 
                the data bank, except that the Secretary may exclude 
                information contained in the data bank pursuant to 
                subsection (d)(1)(B) if the Secretary determines that 
                such information is not useful to clinicians and 
                researchers.
                    ``(B) Patients seeking enrollment as subjects in 
                clinical trials.--With respect to means of disclosure 
                under this subsection that are intended for patients 
                seeking to enroll as subjects in clinical trials, the 
                Secretary shall through such means disclose all 
                information in the data bank, except that the Secretary 
                may exclude any information that the Secretary 
                determines is not useful to such patients. The 
                Secretary may not under the preceding sentence exclude 
                information of the type referred to in paragraph 
                (3)(B).
            ``(6) Registration information; date of disclosure.--In the 
        case of information regarding a clinical trial that is 
        contained in the data bank pursuant to subparagraph (A) or (B) 
        of subsection (d)(1), disclosures required in paragraph (5) 
        shall begin in accordance with the following:
                    ``(A) 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.
                    ``(B) 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 
                paragraph (7)(A).
            ``(7) Results of trial; date of disclosure.--
                    ``(A) In general.--In the case of information 
                regarding a clinical trial that is contained in the 
                data bank pursuant to subsection (d)(2), disclosures 
                required in paragraph (5) shall begin promptly after 
                the information is submitted to the Secretary, subject 
                to subparagraph (B).
                    ``(B) Waiver regarding results of trial.--In the 
                case of information contained in the data bank on 
                waivers under subsection (d)(2)(C), disclosures 
                required in paragraph (5) shall begin promptly after 
                the waiver is provided.
    ``(f) Determination of Violations.--
            ``(1) Compliance audits.--
                    ``(A) In general.--The Secretary shall conduct 
                periodic audits of responsible persons for clinical 
                trials receiving awards described in subsection (a)(1) 
                in order to determine whether the persons have 
                submitted information as required under agreements 
                under subparagraphs (A) and (B) of such subsection, 
                including determining whether any of the information is 
                false or misleading.
                    ``(B) 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 
                (g)(1)(A)(i), taking into account the number and 
                severity of the violations involved.
            ``(2) Notice to responsible persons.--Promptly after 
        determining that a responsible person for a clinical trial is 
        in violation of a requirement under subparagraph (A) or (B) of 
        subsection (a)(1), the Secretary shall notify the person in 
        writing of the violation.
    ``(g) Actions of Secretary Regarding Violations.--
            ``(1) In general.--If a responsible person for a clinical 
        trial is in violation of an agreement under subparagraph (A) or 
        (B) of subsection (a)(1) (including submitting information 
        under such a subparagraph that is false or misleading), the 
        following applies, subject to paragraph (4) of this subsection:
                    ``(A) In any case in which the violation is not 
                corrected within 30 days after the Secretary provides 
                to the responsible person a notice under subsection 
                (f)(2) regarding the violation:
                            ``(i) Through Internet sites under 
                        subsection (e)(3) and such other means as the 
                        Secretary determines to be appropriate, the 
                        Secretary shall announce to the public that the 
                        responsible person is in violation of this 
                        section. For purposes of the preceding 
                        sentence, the Secretary shall maintain a list 
                        of responsible persons in violation that is 
                        available to the public.
                            ``(ii) The responsible person is, pursuant 
                        to subsection (a)(1)(D), subject to a 
                        liquidated penalty of not more than a total of 
                        $15,000 for all violations adjudicated in a 
                        single proceeding in the case of an individual, 
                        and $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. 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 paragraphs apply to a penalty 
                        imposed under paragraph (1) or (2) of such 
                        section.
                    ``(B) In any case in which the violation is a 
                significant violation and is not corrected within 60 
                days after the Secretary provides to the responsible 
                person a notice under subsection (f)(2) regarding the 
                violation, the Secretary shall, after notice and an 
                opportunity for a hearing, consider the person to be 
                ineligible for any future awards described in 
                subsection (a)(1) until the violation is corrected, 
                except that notice and an opportunity for a hearing are 
                not required if a hearing regarding such violation was 
                held pursuant to subparagraph (A)(ii).
                    ``(C) In any case in which the violation is a 
                failure to submit to the data bank the results of the 
                trial by the due date under subsection (d)(2)(A)(i), 
                the Secretary shall order the responsible person to 
                submit to the data bank periodic reports on the 
                progress being made toward submission of the results, 
                which reports shall be submitted not less frequently 
                that once every two years until the results are 
                submitted to the data bank.
            ``(2) Relation to related requirements.--If a responsible 
        person for a clinical trial is ineligible for purposes of 
        section 565(f)(1)(B) or 566(a)(2) of the Federal Food, Drug, 
        and Cosmetic Act, the person is ineligible for any award 
        described in subsection (a)(1) during the period of such 
        ineligibility, without regard to whether the person is 
        ineligible under paragraph (1)(B) of this subsection.
            ``(3) False or misleading information.--If the Secretary 
        determines that the responsible person for a clinical trial has 
        submitted to the data bank information that is false or 
        misleading, and if on such basis a civil money has been imposed 
        under paragraph (1)(A)(ii) on such person or the person has 
        becomes ineligible within the meaning of paragraph (1)(B) or 
        (2), the Secretary shall remove the information from the data 
        bank, subject to any judicial review of such action or actions 
        of the Secretary.
            ``(4) Waiver regarding ineligibility for funding.--With 
        respect to a responsible person who is ineligible for purposes 
        of paragraph (1)(B) or (2), the Secretary may waive the 
        applicability of such paragraph in order to provide for a 
        clinical trial if the Secretary determines that providing the 
        waiver is in the public interest or consistent with the 
        protection of the public health. Each such determination of the 
        Secretary shall be published in the Federal Register.
            ``(5) Funding of comparative studies.--Penalties collected 
        by the Secretary under paragraph (1)(A)(ii) shall be used by 
        the Secretary to make awards of grants, contracts, or 
        cooperative agreements for the conduct of comparative clinical 
        trials to determine the safety or relative effectiveness of 
        products.
    ``(h) Criteria.--The Secretary shall establish criteria regarding 
compliance with this section.
    ``(i) 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 (a)(1), the 
Secretary shall consider the costs of complying with requirements under 
such subsection as part of the direct costs of conducting the clinical 
trial involved.
    ``(j) 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 `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.
            ``(4) The term `data bank' means the data bank under 
        subsection (b).
            ``(5) The term `device' has the meaning given such term in 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act.
            ``(6) 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.
            ``(7) 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.
            ``(8) The term `product' has the meaning indicated for such 
        term in subsection (a)(1).
            ``(9) The term `researchers' means individuals who conduct 
        research on drugs or devices.
            ``(10) The term `responsible person', with respect to a 
        clinical trial to determine the safety or effectiveness of a 
        use of a product, has the following meaning, as applicable:
                    ``(A) In any case in which an application has been 
                submitted for an exemption under section 505(i) or 
                520(g)(2)(A) with respect to the trial, 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 or will be 
                        providing monetary support for the trial and is 
                        responsible for conducting the trial.
            ``(11) The term `unapproved product' means a product that 
        is not an approved product.
            ``(12) The term `unapproved use', with respect to an 
        approved product, means a use that is not an approved use.
    ``(k) 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 2004 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) Clinical Investigations in Progress.--With respect to a 
clinical investigation to determine the safety or effectiveness of a 
use of a drug, biological product, or device, 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, and if the 
investigation is being conducted with an award of a grant, contract, or 
cooperative agreement under the Public Health Service Act, the 
investigation becomes subject to section 491A of such Act (as added by 
subsection (a) of this section) upon the expiration of 30 days after 
the date of the enactment of this Act, except that registration 
information required pursuant to subsection (d)(1) of such section 491A 
is due upon the expiration of such 30 days. For purposes of the 
preceding sentence, the term ``clinical investigation'' has the meaning 
that applies for purposes of subsection (j)(3) of such section 491A.
    (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 491A of the Public Health Service Act (as added by 
        subsection (a) of this section) or other applicable provisions 
        of law.

SEC. 3. OTHER CONDITIONS REGARDING DATA BANK ON CLINICAL TRIALS.

    (a) Investigational Drugs and Devices.--
            (1) In general.--Subchapter E of chapter V of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
        amended by adding at the end the following section:

``SEC. 565. INVESTIGATIONAL DRUGS AND DEVICES; CONDITIONS REGARDING 
              DATA BANK ON CLINICAL TRIALS.

    ``(a) In General.--
            ``(1) Conditions for exemptions.--Except as provided in 
        paragraph (2), an exemption under section 505(i) or 
        520(g)(2)(A) for an investigation to determine the safety or 
        effectiveness of the use of a drug or device (referred to in 
        this section as a `product') may not be considered to be in 
        effect unless--
                    ``(A) the sponsor of the investigation agrees to 
                register the investigation with the Secretary;
                    ``(B) the sponsor of the investigation agrees to 
                provide to the Secretary information on the results of 
                the investigation; and
                    ``(C) the sponsor of the investigation agrees to 
                the disclosure to the public of information regarding 
                the investigation.
            ``(2) Exception.--Paragraph (1) does not apply to an 
        investigation 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 such paragraph 
        does apply if the trial is designed solely to investigate 
        pharmacokinetics in a special population or populations.
    ``(b) Institutional Review Boards.--For purposes of subsection (a), 
the Secretary shall amend parts 50, 56, and 812 of title 21, Code of 
Federal Regulations, to provide that--
            ``(1) the functions of institutional review boards under 
        such parts include--
                    ``(A) determining whether investigations are 
                registered under subsection (a)(1)(A); and
                    ``(B) denying the approval of the boards for 
                investigations that are not registered under such 
                subsection;
            ``(2) any approval of an institutional review board 
        regarding an investigation is not effective under such parts if 
        the investigation is not registered under such subsection; and
            ``(3) upon request of an institutional review board for 
        such an investigation, the Secretary will provide to the board 
        a copy of the registration for the investigation under such 
        subsection (which copy will be the registration as submitted to 
        the Secretary, together with all updates to the registration).
    ``(c) Certain Exemptions.--The reference in subsection (a) to an 
exemption under section 505(i) includes an exemption described in 
section 312.2(b) of title 21, Code of Federal Regulations. The 
reference in such subsection to an exemption under section 520(g)(2)(A) 
includes an exemption described in section 812.2(b) of such title 21.
    ``(d) Relationship to Similar Requirements.--For purposes of 
subsection (a):
            ``(1) The responsibilities of a sponsor of an 
        investigation, and of the Secretary, are the same as apply 
        under section 491A of the Public Health Service Act with 
        respect to responsible persons, except to the extent of taking 
        into account that this section concerns conditions for 
        exemptions referred to in subsection (a)(1) and section 491A of 
        such Act concerns conditions for the receipt of an award under 
        such Act.
            ``(2) The Secretary shall administer the program under this 
        section and the program under section 491A of such Act as 
        substantially a single program, shall not require duplicative 
        registrations, and shall otherwise avoid duplicative 
        activities.
    ``(e) Determination of Violations.--
            ``(1) Compliance audits.--
                    ``(A) In general.--The Secretary shall conduct 
                periodic audits of sponsors of investigations for which 
                exemptions referred to in subsection (a)(1) are in 
                effect in order to determine whether the sponsors have 
                submitted information as required under agreements 
                under subparagraphs (A) and (B) of such subsection, 
                including determining whether any of the information is 
                false or misleading.
                    ``(B) Priority.--In conducting audits under 
                subparagraph (A), the Secretary shall give priority to 
                sponsors of investigations who have at any time been 
                included on the list under subsection (f)(1)(A)(i), 
                taking into account the number and severity of the 
                violations involved.
            ``(2) Notice to sponsors.--Promptly after determining that 
        a sponsor of an investigation is in violation of a requirement 
        under subparagraph (A) or (B) of subsection (a)(1), the 
        Secretary shall notify the sponsor in writing of the violation.
    ``(f) Actions of Secretary Regarding Violations.--
            ``(1) In general.--If a sponsor of an investigation is in 
        violation of an agreement under subparagraph (A) or (B) of 
        subsection (a)(1) (including submitting information under such 
        a subparagraph that is false or misleading), the following 
        applies, subject to paragraph (2) of this subsection:
                    ``(A) In any case in which the violation is not 
                corrected within 30 days after the Secretary provides 
                to the sponsor a notice under subsection (e)(2) 
                regarding the violation:
                            ``(i) Through Internet sites operated 
                        pursuant to subsection (d) and such other means 
                        as the Secretary determines to be appropriate, 
                        the Secretary shall announce to the public that 
                        the sponsor is in violation of this section. 
                        For purposes of the preceding sentence, the 
                        Secretary shall maintain a list of sponsors in 
                        violation that is available to the public.
                            ``(ii) The sponsor is subject to a civil 
                        penalty of not more than a total of $15,000 for 
                        all violations adjudicated in a single 
                        proceeding in the case of an individual, and 
                        $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. Paragraphs (3) through (5) of 
                        section 303(f) apply to the imposition of such 
                        a penalty to the same extent and in the same 
                        manner as such paragraphs apply to a penalty 
                        imposed under paragraph (1) or (2) of such 
                        section.
                    ``(B) In any case in which the violation is a 
                significant violation and is not corrected within 60 
                days after the Secretary provides to the sponsor a 
                notice under subsection (e)(2) regarding the violation, 
                the Secretary may, after notice and an opportunity for 
                a hearing, consider the sponsor to be ineligible for 
                any future exemptions referred to in subsection (a)(1) 
                for any investigation until the violation is corrected, 
                except that notice and an opportunity for a hearing are 
                not required if a hearing regarding such violation was 
                held pursuant to subparagraph (A)(ii).
                    ``(C) In any case in which the violation is a 
                failure to submit to the data bank the results of the 
                investigation by the due date that applies pursuant to 
                subsection (d), the Secretary shall order the sponsor 
                of the investigation to submit to the data bank 
                periodic reports on the progress being made toward 
                submission of the results, which reports shall be 
                submitted not less frequently that once every two years 
                until the results are submitted to the data bank.
            ``(2) False or misleading information.--If the Secretary 
        determines that the sponsor of an investigation has submitted 
        to the data bank information that is false or misleading, and 
        if on such basis a civil money has been imposed under paragraph 
        (1)(A)(ii) on the sponsor or the sponsor has becomes ineligible 
        within the meaning of paragraph (1)(B), the Secretary shall 
        remove the information from the data bank, subject to any 
        judicial review of such action or actions of the Secretary.
            ``(3) Waiver regarding ineligibility for exemptions.--With 
        respect to a sponsor who is ineligible for purposes of 
        paragraph (1)(B), the Secretary may waive the applicability of 
        such paragraph in order to provide for an investigation if the 
        Secretary determines that providing the waiver is in the public 
        interest or consistent with the protection of the public 
        health. Each such determination of the Secretary shall be 
        published in the Federal Register.
            ``(4) Funding of comparative studies.--Penalties collected 
        by the Secretary under paragraph (1)(A)(ii) shall be used by 
        the Secretary to make awards of grants or contracts for the 
        conduct of comparative investigations to determine the safety 
        or relative effectiveness of products.
    ``(g) Definitions.--
            ``(1) In general.--Definitions under section 491A(j) of the 
        Public Health Service Act apply for purposes of this section, 
        subject to paragraph (2).
            ``(2) Investigation.--For purposes of this section, the 
        term `investigation' means a clinical investigation within the 
        meaning of section 505(i) (in the case of drug), or within the 
        meaning of section 520(g) (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.''.
            (2) Conforming amendments.--Chapter V of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended--
                    (A) 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 565 (relating to information on investigations).''; and
                    (B) 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 565 (relating to information on investigations).''.
    (b) Premarket Application or Report; Labeling and Advertising.--
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act, 
as amended by subsection (a) of this section, is amended by adding at 
the end the following section:

``SEC. 566. PREMARKET APPLICATION OR REPORT; LABELING AND ADVERTISING; 
              RELATION TO DATA BANK ON CLINICAL TRIALS.

    ``(a) Premarket Application or Report.--If a person submits to the 
Secretary an application under section 505(b) or 515 or a report under 
section 510(k), and one or more of the investigations presented to the 
Secretary by the person for purposes of the application or report are 
investigations that are not subject to requirements under section 565 
or under section 491A of the Public Health Service, and if the person 
was the principal investigator or the responsible person for the 
investigation involved, the following applies:
            ``(1) 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 or report is submitted to the Secretary, 
                been submitted to the data bank described in such 
                section 491A to the same extent as would have been 
                required as of such date if the investigation had been 
                subject to such requirements (without regard to 
                timeframes for the submission of information that would 
                have applied before such date under such section); 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 such requirements.
            ``(2) If the person is subject to a civil penalty under 
        paragraph (1), the Secretary, in addition to such penalty, may, 
        after notice and an opportunity for a hearing, consider the 
        person to be ineligible for any future exemptions under section 
        505(i) or 520(g)(2)(A) for any investigation until the 
        information involved is submitted to the data bank as described 
        in paragraph (1), except that notice and an opportunity for a 
        hearing are not required if a hearing regarding such violation 
        was held pursuant to paragraph (1).
    ``(b) Labeling and Advertisements.--If a person disseminates 
labeling, or an advertisement or other descriptive printed matter, for 
a drug or device for human use and the labeling, advertisement, or 
other matter refers to an investigation that is not subject to 
requirements under section 565 or under section 491A of the Public 
Health Service, and if the person was the principal investigator or the 
responsible person for the investigation, the person is subject to a 
civil penalty--
            ``(1) 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 described in such section 491A to the same extent as would 
        have been required as of such date if the investigation had 
        been subject to such requirements (without regard to timeframes 
        for the submission of information that would have applied 
        before such date under such section); and
            ``(2) 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 such requirements.
    ``(c) Amount of Civil Penalty; Procedure.--A civil penalty under 
subsection (a)(1) or (b) 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 $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. Paragraphs (3) through (5) of 
section 303(f) apply to the imposition of such a penalty to the same 
extent and in the same manner as such paragraphs apply to a penalty 
imposed under paragraph (1) or (2) of such section.
    ``(d) Biologics License Application.--Subsections (a) and (c) apply 
with respect to a biologics license application under section 351 of 
the Public Health Service Act to the same extent and in the same manner 
as such subsections apply with respect to an application or report 
referred to in subsection (a).
    ``(e) Definitions.--For purposes of this section:
            ``(1) The term `investigation' has the meaning given such 
        term in section 565(g).
            ``(2) The term `responsible person' has the meaning given 
        such term in section 491A(j) of the Public Health Service Act. 
        ''.
    (c) Clinical Investigations in Progress.--With respect to a 
clinical investigation to determine the safety or effectiveness of a 
use of a drug, biological product, or device, if the final data 
collection from subjects in the investigation on the primary outcome 
has not been completed as of the date of the enactment of this Act, and 
if the investigation is one for which an exemption under section 505(i) 
or 520(g)(2)(A) of the Federal Food, Drug, and Cosmetic Act is in 
effect, the investigation becomes subject to section 565 of such Act 
(as added by subsection (a) of this section) upon the expiration of 30 
days after the date of the enactment of this Act, except that 
registration information required pursuant to subsection (d) of such 
section 565 is due upon the expiration of such 30 days. For purposes of 
the preceding sentence, the term ``clinical investigation'' has the 
meaning given such term in subsection (g)(2) of such section 565.

SEC. 4. RULE OF CONSTRUCTION REGARDING AUTHORITY OF SECRETARY FOR 
              PUBLIC DISCLOSURE OF INFORMATION ON CLINICAL TRIALS.

    This Act and the amendments made by this Act may not be construed 
as limiting the authority of the Secretary of Health and Human Services 
to disclose to the public information on clinical trials to determine 
the safety or effectiveness of the use of drugs, which authority was in 
effect as of the day before the date of the enactment of this Act.
                                 <all>