[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3807 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3807

To amend the Public Health Service Act and the Federal Food, Drug, and 
   Cosmetic Act to improve drug safety and oversight, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 3, 2006

 Mr. Enzi (for himself and Mr. Kennedy) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act and the Federal Food, Drug, and 
   Cosmetic Act to improve drug safety and oversight, 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 ``Enhancing Drug Safety and Innovation 
Act of 2006''.

           TITLE I--RISK EVALUATION AND MITIGATION STRATEGIES

SEC. 101. RISK EVALUATION AND MITIGATION STRATEGIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(o) Risk Evaluation and Mitigation Strategy.--
            ``(1) In general.--In the case of any drug subject to 
        subsection (b) or (j) or section 351 of the Public Health 
        Service Act for which a risk evaluation and mitigation strategy 
        is approved as provided for in this subsection, the applicant 
        shall comply with the requirements of such strategy, which--
                    ``(A) shall require the elements under paragraph 
                (3); and
                    ``(B) may require one or more additional elements 
                under paragraph (4) or (5), so long as the Secretary 
                makes the determination required with respect to each 
                such element.
            ``(2) Definitions.--In this subsection:
                    ``(A) Serious risk.--The term `serious risk' means 
                a risk of a serious adverse drug experience as defined 
                in section 314.80 of title 21, Code of Federal 
                Regulations (or any successor regulation).
                    ``(B) Unexpected serious risk.--The term 
                `unexpected serious risk' means a serious adverse drug 
                experience as defined in section 314.80 of title 21, 
                Code of Federal Regulations (or any successor 
                regulation) that is not listed in the labeling of a 
                drug, or that may be symptomatically and 
                pathophysiologically related to an adverse drug 
                experience identified in the labeling, but differs from 
                such adverse drug experience because of greater 
                severity or specificity.
                    ``(C) Empirical signal of a serious risk.--The term 
                `empirical signal of a serious risk' means information 
                related to a serious adverse drug experience as defined 
                in section 314.80 of title 21, Code of Federal 
                Regulations (or any successor regulation) associated 
                with use of a drug and derived from--
                            ``(i) a clinical trial;
                            ``(ii) adverse event reports;
                            ``(iii) a post-approval study, including a 
                        study under paragraph (4)(D); or
                            ``(iv) peer-reviewed biomedical literature.
                    ``(D) New safety information.--The term `new safety 
                information' with respect to a drug means information 
                about--
                            ``(i) a serious risk or an unexpected 
                        serious risk associated with use of the drug 
                        that the Secretary has become aware of since 
                        the last assessment of the approved risk 
                        evaluation and mitigation strategy for the 
                        drug; or
                            ``(ii) the effectiveness of the approved 
                        risk evaluation and mitigation strategy for the 
                        drug.
                    ``(E) Drug safety oversight board.--The term `Drug 
                Safety Oversight Board' means a body of scientists who 
                have been appointed to serve from offices throughout 
                the Food and Drug Administration and other Federal 
                agencies to provide oversight and advice to the 
                Secretary through the Director of the Center for Drug 
                Evaluation and Research of the Food and Drug 
                Administration on the management of important drug 
                safety issues and which meets monthly.
            ``(3) Required elements of a risk evaluation and mitigation 
        strategy.--The risk evaluation and mitigation strategy for a 
        drug shall require--
                    ``(A) labeling for the drug for use by health care 
                providers as approved under subsection (c);
                    ``(B)(i) submission of reports for the drug as 
                required under subsection (k); and
                    ``(ii) for a drug that is a vaccine--
                            ``(I) analysis by the Secretary of reports 
                        to the Vaccine Adverse Event Reporting Systems 
                        (VAERS); or
                            ``(II) surveillance by the Secretary using 
                        the Vaccine Safety Datalink (VSD) or successor 
                        databases;
                    ``(C) a pharmacovigilance statement as to whether--
                            ``(i) the reports under subparagraph (B)(i) 
                        or, for a vaccine, the analysis and 
                        surveillance under subparagraph (B)(ii), and 
                        the periodic assessment under subparagraph (E), 
                        are sufficient to assess the serious risks and 
                        to identify unexpected serious risks of the 
                        drug; or
                            ``(ii) studies under paragraph (4)(D) or 
                        clinical trials under paragraph (4)(E) are 
                        needed to assess the serious risks and identify 
                        unexpected serious risks of the drug;
                    ``(D) a justification for the pharmacovigilance 
                statement in subparagraph (C) that takes into 
                consideration--
                            ``(i) the estimated size of the treatment 
                        population for the drug;
                            ``(ii) the seriousness of the disease or 
                        condition that the drug is used to treat;
                            ``(iii) the expected or actual duration of 
                        treatment with the drug;
                            ``(iv) the availability and safety of a 
                        drug or other treatment, if any, for such 
                        disease or condition to which the drug may be 
                        compared; and
                            ``(v) the seriousness of the risk at issue 
                        and its background incidence in the population; 
                        and
                    ``(E) a timetable for submission of assessments of 
                the strategy, that--
                            ``(i) shall be no less frequently than once 
                        annually for the first 3 years after the drug 
                        is initially approved under subsection (c) or 
                        licensed under section 351 of the Public Health 
                        Service Act, and at a frequency determined by 
                        the Secretary for subsequent years;
                            ``(ii) may be increased or reduced by the 
                        Secretary in frequency as necessary; and
                            ``(iii) may be eliminated after the first 3 
                        years if the Secretary determines that serious 
                        risks of the drug have been adequately 
                        identified and assessed and are being 
                        adequately managed.
            ``(4) Additional potential elements of a risk evaluation 
        and mitigation strategy.--
                    ``(A) In general.--The risk evaluation and 
                mitigation strategy for a drug may require one or more 
                of the additional elements described in this paragraph, 
                so long as the Secretary makes the determination 
                required with respect to each such element.
                    ``(B) Medguide.--The risk evaluation and mitigation 
                strategy for a drug may require that the applicant 
                develop for distribution to each patient when the drug 
                is dispensed--
                            ``(i) a Medication Guide, as provided for 
                        under part 208 of title 21, Code of Federal 
                        Regulations (or any successor regulations); or
                            ``(ii) a patient package insert, if the 
                        Secretary determines that such insert may help 
                        minimize a serious risk of the drug.
                    ``(C) Communication plan.--The risk evaluation and 
                mitigation strategy for a drug may require that the 
                applicant conduct a communication plan to health care 
                providers, if, with respect to such drug, the Secretary 
                determines that such plan may support implementation of 
                an element of the strategy under subparagraph (D) or 
                (E) or under paragraph (5), which may include--
                            ``(i) sending letters to health care 
                        providers;
                            ``(ii) disseminating information about the 
                        elements of the risk evaluation and mitigation 
                        strategy to encourage compliance by health care 
                        providers with components that apply to such 
                        health care providers, or to explain certain 
                        safety protocols (such as medical monitoring by 
                        periodic laboratory tests); or
                            ``(iii) disseminating information to health 
                        care providers through professional societies 
                        about any serious risks of the drug and how to 
                        prescribe and use the drug safely.
                    ``(D) Post-approval studies.--The risk evaluation 
                and mitigation strategy for a drug may require that the 
                applicant or the Secretary conduct an appropriate post-
                approval study of the drug (with target commencement 
                and completion dates), if the Secretary determines the 
                study is necessary to assess an empirical signal of a 
                serious risk with use of the drug or to identify 
                unexpected serious risks in domestic populations who 
                use the drug but were not included in studies used to 
                approve the drug (such as older people, people with 
                comorbidities, pregnant women, or children), such as a 
                prospective or retrospective observational study.
                    ``(E) Post-approval clinical trials.--The risk 
                evaluation and mitigation strategy for a drug may 
                require that the applicant for a drug for which there 
                is no effective approved application under subsection 
                (j) as of the date that the requirement is first 
                imposed conduct an appropriate post-approval clinical 
                trial of the drug (with target commencement and 
                completion dates), to be included in the clinical trial 
                registry database and clinical trial results database 
                provided for under section 402(j) of the Public Health 
                Service Act, if the Secretary determines that the 
                clinical trial is necessary, and that a study under 
                subparagraph (D) will likely be inadequate, to assess 
                an empirical signal of a serious risk with use of the 
                drug;
                    ``(F) Preclearance.--The risk evaluation and 
                mitigation strategy for a drug may require that the 
                applicant submit to the Secretary advertisements of the 
                drug for preclearance, if the Secretary determines that 
                such preclearance is necessary to ensure compliance 
                with section 502(n) with respect to the disclosure of 
                information about a serious risk listed in the labeling 
                of the drug, so long as advertisements required to be 
                submitted under this subparagraph are reviewed and 
                cleared within 30 days by the Secretary.
                    ``(G) Specific disclosures.--The risk evaluation 
                and mitigation strategy for a drug may require that the 
                applicant include a specific disclosure in 
                advertisements of the drug, if the Secretary determines 
                that advertisements lacking such disclosure would be 
                false or misleading or that such disclosure is 
                necessary to protect public health and safety--
                            ``(i) of the date the drug was approved and 
                        that the existing information may not have 
                        identified or fully assessed all serious risks 
                        of using the drug;
                            ``(ii) about a serious adverse event listed 
                        in the labeling of the drug; or
                            ``(iii) about a protocol to ensure safe use 
                        described in the labeling of the drug; or
                    ``(H) Temporary moratorium.--The risk evaluation 
                and mitigation strategy for a drug may require that for 
                a fixed period after initial approval, not to exceed 2 
                years, the applicant not issue or cause to be issued 
                direct-to-consumer advertisements of the drug, if the 
                Secretary determines that disclosure under subparagraph 
                (G) is inadequate to protect public health and safety, 
                and that such prohibition is necessary to protect 
                public health and safety while additional information 
                about serious risks of the drug is collected, 
                considering--
                            ``(i) the number of patients who may be 
                        treated with the drug;
                            ``(ii) the seriousness of the condition for 
                        which the drug will be used;
                            ``(iii) the serious adverse events listed 
                        in the labeling of the drug;
                            ``(iv) the extent to which patients have 
                        access to other approved drugs in the 
                        pharmacological class of the drug and with the 
                        same intended use as the drug; and
                            ``(v) the extent to which studies used to 
                        approve the drug may not have identified 
                        serious risks that might occur among patients 
                        expected to be treated with the drug.
            ``(5) Restrictions on distribution and use.--
                    ``(A) In general.--If the Secretary determines that 
                a drug presents a significant risk to public health, 
                and provides significant benefits to patients, the risk 
                evaluation and mitigation strategy may require 
                restrictions on distribution and use to address such 
                risk of the drug, so long as application of elements 
                under paragraph (4) are insufficient to manage such 
                risk.
                    ``(B) Limits on restrictions.--Such restrictions 
                under subparagraph (A) shall be--
                            ``(i) commensurate with the risk;
                            ``(ii) necessary to ensure safe use of the 
                        drug given the risk; and
                            ``(iii) not unduly burdensome on patient 
                        access to the drug, particularly for patients 
                        with serious or life-threatening diseases or 
                        conditions.
                    ``(C) Elements.--The restrictions on distribution 
                and use described under subparagraph (A) shall include 
                one or more goals to evaluate or mitigate a serious 
                risk listed in the labeling of the drug and may require 
                that--
                            ``(i) health care providers that prescribe 
                        the drug have particular training or 
                        experience, or elect to be specially certified;
                            ``(ii) pharmacies, practitioners, or health 
                        care settings that dispense the drug elect to 
                        be specially certified;
                            ``(iii) the drug be dispensed to patients 
                        only in certain health care settings, such as 
                        hospitals;
                            ``(iv) the drug be dispensed to patients 
                        with evidence or other documentation of safe-
                        use conditions, such as laboratory test 
                        results;
                            ``(v) each patient using the drug be 
                        subject to certain monitoring; or
                            ``(vi) each patient using the drug be 
                        enrolled in a registry.
                    ``(D) Compliance system.--The restrictions on 
                distribution and use described under subparagraph (A) 
                may require a compliance system through which the 
                applicant is able to--
                            ``(i) monitor and evaluate compliance with 
                        the restrictions by health care providers, 
                        pharmacists, patients, and other parties in the 
                        health care system who are responsible for 
                        implementing the restrictions;
                            ``(ii) work to improve implementation of 
                        the restrictions by health care providers, 
                        pharmacists, patients, and other parties in the 
                        health care system who are responsible for 
                        implementing the restrictions; and
                            ``(iii) limit participation by those health 
                        care providers, pharmacists, and other parties 
                        in the health care system--
                                    ``(I) who are responsible for 
                                implementing the restrictions; and
                                    ``(II) whom the applicant knows 
                                have failed to meet their 
                                responsibilities for implementing the 
                                restrictions, after the applicant has 
                                informed such party of such failure and 
                                such party has not remedied such 
                                failure.
            ``(6) Submission and review of risk evaluation and 
        mitigation strategy.--
                    ``(A) Proposed risk evaluation and mitigation 
                strategy.--An applicant shall include in an application 
                under subsection (b) or section 351 of the Public 
                Health Service Act (including in a supplemental 
                application seeking a new indication if no risk 
                evaluation and mitigation strategy for the drug is in 
                effect under this subsection) a proposed risk 
                evaluation and mitigation strategy, which--
                            ``(i) shall include the minimal elements 
                        required under paragraph (3); and
                            ``(ii) may also include additional elements 
                        as provided for under paragraphs (4) and (5).
                    ``(B) Assessment and modification of a risk 
                evaluation and mitigation strategy.--
                            ``(i) In general.--The applicant may submit 
                        to the Secretary an assessment of, and propose 
                        a modification to, the approved risk evaluation 
                        and mitigation strategy for a drug at any time, 
                        and shall submit such an assessment, which may 
                        propose such a modification--
                                    ``(I) when submitting a 
                                supplemental application for a new 
                                indication under subsection (b) or 
                                section 351 of the Public Health 
                                Service Act;
                                    ``(II) when required by the 
                                strategy, as provided for in the 
                                timetable under paragraph (3)(E);
                                    ``(III) within a time specified by 
                                the Secretary, not to be less than 45 
                                days, when ordered by the Secretary if 
                                the Secretary determines that new 
                                safety information indicates that an 
                                element under paragraph (3) or (4) 
                                should be modified or included in the 
                                strategy;
                                    ``(IV) within 90 days when ordered 
                                by the Secretary if the Secretary 
                                determines that new safety information 
                                indicates that an element under 
                                paragraph (5) should be modified or 
                                included in the strategy; or
                                    ``(V) within 15 days when ordered 
                                by the Secretary if the Secretary 
                                determines that there may be a cause 
                                for action by the Secretary under 
                                subsection (e).
                            ``(ii) Assessment.--An assessment of the 
                        performance and adequacy of the approved risk 
                        evaluation and mitigation strategy for a drug 
                        shall include--
                                    ``(I) with respect to any goal 
                                under paragraph (5), an assessment of 
                                whether the restrictions on 
                                distribution and use are meeting the 
                                goal or whether the goal or such 
                                restrictions should be modified;
                                    ``(II) with respect to any post-
                                approval study required under paragraph 
                                (4)(D), the status of such study, the 
                                expected completion date, and whether 
                                any difficulties completing the study 
                                have been encountered; and
                                    ``(III) with respect to any post-
                                approval clinical trial required under 
                                paragraph (4)(E), whether enrollment 
                                has begun, the number of participants 
                                enrolled, the expected completion date, 
                                and whether any difficulties completing 
                                the clinical trial have been 
                                encountered.
                            ``(iii) Modification.--A modification 
                        (whether an enhancement or a reduction) to the 
                        approved risk evaluation and mitigation 
                        strategy for a drug may include the addition or 
                        modification of any element under subparagraph 
                        (A), (C), or (D) of paragraph (3) or the 
                        addition, modification, or removal of any 
                        element under paragraph (4) or (5), such as--
                                    ``(I) a labeling change, including 
                                the addition of a boxed warning;
                                    ``(II) adding a post-approval study 
                                or clinical trial requirement;
                                    ``(III) modifying a post-approval 
                                study or clinical trial requirement 
                                (such as a change in trial design due 
                                to legitimate difficulties recruiting 
                                participants);
                                    ``(IV) adding, modifying, or 
                                removing a restriction on advertising 
                                under subparagraph (F), (G), or (H) of 
                                paragraph (4);
                                    ``(V) adding, modifying, or 
                                removing a restriction on distribution 
                                or use under paragraph (5); or
                                    ``(VI) modifying the timetable for 
                                assessments of the strategy under 
                                paragraph (3)(E).
                    ``(C) Review.--The Secretary shall promptly review 
                the proposed risk evaluation and mitigation strategy 
                for a drug submitted under paragraph (A), or an 
                assessment of the approved risk evaluation and 
                mitigation strategy for a drug submitted under 
                subparagraph (B).
                    ``(D) Discussion.--The Secretary shall initiate 
                discussions of the proposed risk evaluation and 
                mitigation strategy for a drug submitted under 
                subparagraph (A), or of an assessment of the approved 
                risk evaluation and mitigation strategy for a drug 
                submitted under subparagraph (B), with the applicant to 
                determine a mutually agreeable strategy--
                            ``(i) when submitted as part of an 
                        application or supplemental application under 
                        subparagraph (A) or (B)(i)(I), not less than 60 
                        days before the action deadline for the 
                        application that has been agreed to by the 
                        Secretary and that has been set forth in goals 
                        identified in letters of the Secretary 
                        (relating to the use of fees collected under 
                        section 736 to expedite the drug development 
                        process and the review of human drug 
                        applications);
                            ``(ii) when submitted under subparagraph 
                        (B)(i)(II) or (III), not later than 20 days 
                        after such submission;
                            ``(iii) when submitted voluntarily by the 
                        applicant or under subparagraph (B)(i)(IV), not 
                        later than 30 days after such submission; or
                            ``(iv) when submitted under subparagraph 
                        (B)(i)(V), not later than 10 days after such 
                        submission.
                    ``(E) Action.--
                            ``(i) In general.--Unless the applicant 
                        requests the dispute resolution process 
                        described under subparagraph (F), the Secretary 
                        shall approve and describe the risk evaluation 
                        and mitigation strategy for a drug, or any 
                        modification to the strategy--
                                    ``(I) as part of the action letter 
                                on the application, when a proposed 
                                strategy is submitted under 
                                subparagraph (A) or an assessment of 
                                the strategy is submitted under 
                                subparagraph (B)(i)(I); or
                                    ``(II) in an order, which shall be 
                                made public, issued not later than 50 
                                days after the date discussions of such 
                                modification begin under subparagraph 
                                (C), when an assessment of the strategy 
                                is submitted voluntarily by the 
                                applicant or under subclause (II), 
                                (III), (IV), or (V) of subparagraph 
                                (B)(i).
                            ``(ii) Inaction.--An approved risk 
                        evaluation and mitigation strategy shall remain 
                        in effect until the Secretary acts, if the 
                        Secretary fails to act as provided under clause 
                        (i).
                    ``(F) Dispute resolution.--
                            ``(i) Request for review.--Not earlier than 
                        15 days, and not later than 35 days, after 
                        discussions under subparagraph (D) have begun 
                        to determine a mutually agreeable risk 
                        evaluation and mitigation strategy, the 
                        applicant may request in writing that a dispute 
                        about the strategy be reviewed by the Drug 
                        Safety Oversight Board.
                            ``(ii) Scheduling review.--If the applicant 
                        requests review under clause (i), the 
                        Secretary--
                                    ``(I) shall schedule the dispute 
                                for review at 1 of the next 2 regular 
                                meetings of the Drug Safety Oversight 
                                Board, whichever meeting date is more 
                                practicable; or
                                    ``(II) may convene a special 
                                meeting of the Drug Safety Oversight 
                                Board to review the matter more 
                                promptly, including to meet an action 
                                deadline on an application (including a 
                                supplemental application).
                            ``(iii) Agreement terminates dispute 
                        resolution.--At any time before a decision and 
                        order is issued under clause (vi), the 
                        Secretary and the applicant may reach an 
                        agreement on the risk evaluation and mitigation 
                        strategy, terminating the dispute resolution 
                        process, and the Secretary shall issue an 
                        action letter or order, as appropriate, that 
                        describes the mutually agreeable strategy.
                            ``(iv) Meeting of the board.--At the 
                        meeting of the Drug Safety Oversight Board 
                        described in clause (ii), the Board shall--
                                    ``(I) hear from both parties; and
                                    ``(II) review the dispute.
                            ``(v) Recommendation of the board.--Not 
                        later than 5 days after such meeting of the 
                        Drug Safety Oversight Board, the Board shall 
                        provide a written recommendation on resolving 
                        the dispute to the Secretary.
                            ``(vi) Action by the secretary.--
                                    ``(I) Action letter.--With respect 
                                to a proposed risk evaluation and 
                                mitigation strategy submitted under 
                                subparagraph (A) or to an assessment of 
                                the strategy submitted under 
                                subparagraph (B)(i)(I), the Secretary 
                                shall issue an action letter that 
                                resolves the dispute not later than the 
                                later of--
                                            ``(aa) the action deadline 
                                        referred to in subparagraph 
                                        (D)(i); or
                                            ``(bb) 7 days after 
                                        receiving the recommendation of 
                                        the Drug Safety Oversight 
                                        Board.
                                    ``(II) Order.--With respect to an 
                                assessment of the risk evaluation and 
                                mitigation strategy submitted 
                                voluntarily by the applicant or under 
                                subclause (II), (III), (IV), or (V) of 
                                subparagraph (B)(i), the Secretary 
                                shall issue an order, which shall be 
                                made public, that resolves the dispute 
                                not later than 7 days after receiving 
                                the recommendation of the Drug Safety 
                                Oversight Board.
                            ``(vii) Inaction.--An approved risk 
                        evaluation and mitigation strategy shall remain 
                        in effect until the Secretary acts, if the 
                        Secretary fails to act as provided for under 
                        clause (vi).
                            ``(viii) Effect on action deadline.--With 
                        respect to the application or supplemental 
                        application in which a proposed risk evaluation 
                        and mitigation strategy is submitted under 
                        subparagraph (A) or in which an assessment of 
                        the strategy is submitted under subparagraph 
                        (B)(i)(I), the Secretary shall be considered to 
                        have met the action deadline referred to in 
                        subparagraph (D)(i) with respect to such 
                        application if the applicant requests the 
                        dispute resolution process described in this 
                        subparagraph and if the Secretary--
                                    ``(I) has initiated the discussions 
                                described under such subparagraph not 
                                less than 60 days before such action 
                                deadline; and
                                    ``(II) has complied with the timing 
                                requirements of scheduling review, 
                                providing a written recommendation, and 
                                issuing an action letter under clauses 
                                (ii), (v), and (vi), respectively.
                            ``(ix) Other dispute resolution.--
                        Procedural or scientific matters involving the 
                        review of human drug applications and 
                        supplements that cannot be resolved at the 
                        divisional level may in addition be appealed as 
                        described in letters of the Secretary (relating 
                        to the use of fees collected under section 736 
                        to expedite the drug development process and 
                        the review of human drug applications).
                            ``(x) Disqualification.--No individual who 
                        is an employee of the Food and Drug 
                        Administration and who reviews the application 
                        for a drug or who participated in other dispute 
                        resolution under clause (ix) with respect to 
                        such drug may serve on the Drug Safety 
                        Oversight Board at a meeting under clause (iv) 
                        to review a dispute about the risk evaluation 
                        and mitigation strategy for such drug.
                            ``(xi) Additional expertise.--The Drug 
                        Safety Oversight Board may add members from 
                        offices within the Food and Drug Administration 
                        with relevant expertise, including the Office 
                        of Pediatrics, the Office of Women's Health, or 
                        the Office of Rare Diseases, for a meeting 
                        under clause (iv) of the Drug Safety Oversight 
                        Board.
                    ``(G) Process for addressing drug class effects.--
                            ``(i) In general.--When a concern about a 
                        serious risk of a drug may be related to the 
                        pharmacological class of the drug, the 
                        Secretary may defer assessments of the approved 
                        risk evaluation and mitigation strategies for 
                        such drugs until the Secretary has convened, 
                        after appropriate public notice, one or more 
                        public meetings to consider possible responses 
                        to such concern.
                            ``(ii) Public meetings.--Such public 
                        meetings may include--
                                    ``(I) one or more meetings of the 
                                applicants for such drugs;
                                    ``(II) one or more meetings of an 
                                appropriate advisory committee of the 
                                Food and Drug Administration; or
                                    ``(III) one or more workshops of 
                                scientific experts and other 
                                stakeholders.
                            ``(iii) Action.--After considering the 
                        discussions from any meetings under clause 
                        (ii), the Secretary may--
                                    ``(I) announce in the Federal 
                                Register a planned regulatory action, 
                                including a modification to each risk 
                                evaluation and mitigation strategy, for 
                                drugs in the pharmacological class;
                                    ``(II) seek public comment about 
                                such action; and
                                    ``(III) after seeking such comment, 
                                issue an order addressing such 
                                regulatory action.
                    ``(H) International coordination.--To the extent 
                practicable, the Secretary shall coordinate elements of 
                the risk evaluation and mitigation strategy for a drug, 
                such as the timetable for submission of assessments 
                under paragraph (3)(E), a study under paragraph (4)(D), 
                or a clinical trial under paragraph (4)(E), with 
                efforts to manage the serious risks of such drug by the 
                marketing authorities of other countries whose drug 
                approval and risk management processes the Secretary 
                deems comparable to the drug approval and risk 
                management processes of the United States.
                    ``(I) Effect.--Use of the processes described in 
                subparagraphs (G) and (H) shall not delay action on an 
                application or a supplement to an application for a 
                drug.
                    ``(J) No effect on labeling changes that do not 
                require preapproval.--In the case of a labeling change 
                to which section 314.70 of title 21, Code of Federal 
                Regulations (or any successor regulation), applies for 
                which the submission of a supplemental application is 
                not required or for which distribution of the drug 
                involved may commence upon the receipt by the Secretary 
                of a supplemental application for the change, the 
                submission of an assessment of the approved risk 
                evaluation and mitigation strategy for the drug under 
                this subsection is not required.''.

SEC. 102. ENFORCEMENT.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(x) If it is a drug subject to an approved risk evaluation and 
mitigation strategy under section 505(o) and the applicant for such 
drug fails to--
            ``(1) make a labeling change required by such strategy 
        after the Secretary has completed review of, and acted on, an 
        assessment of such strategy under paragraph (6) of such 
        section; or
            ``(2) comply with a requirement of such strategy with 
        respect to advertising as provided for under subparagraph (F), 
        (G), or (H) of paragraph (4) of such section.''.
    (b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)) is amended--
            (1) by redesignating paragraphs (3), (4), and (5) as 
        paragraphs (4), (5), and (6), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) An applicant (as such term is used in section 505(o)) 
        who knowingly fails to comply with a requirement of an approved 
        risk evaluation and mitigation strategy under such section 
        505(o) shall be subject to a civil money penalty of not less 
        than $15,000 and not more than $250,000 per violation, and not 
        to exceed $1,000,000 for all such violations adjudicated in a 
        single proceeding.'';
            (3) in paragraph (2)(C), by striking ``paragraph (3)(A)'' 
        and inserting ``paragraph (4)(A)'';
            (4) in paragraph (4), as so redesignated, by striking 
        ``paragraph (1) or (2)'' each place it appears and inserting 
        ``paragraph (1), (2), or (3)''; and
            (5) in paragraph (6), as so redesignated, by striking 
        ``paragraph (4)'' each place it appears and inserting 
        ``paragraph (5)''.

SEC. 103. CONFORMING AMENDMENTS.

    (a) Regulation of Biological Products.--Section 351 of the Public 
Health Service Act (42 U.S.C. 262) is amended--
            (1) in subsection (a)(2), by adding at the end the 
        following:
    ``(D) Risk Evaluation and Mitigation Strategy.--A person that 
submits an application for a license under this paragraph shall submit 
to the Secretary as part of the application a proposed risk evaluation 
and mitigation strategy as described under section 505(o) of the 
Federal Food, Drug, and Cosmetic Act.''; and
            (2) in subsection (j), by inserting ``, including the 
        requirements under section 505(o) of such Act,'' after ``, and 
        Cosmetic Act''.
    (b) Preclearance of Advertisement.--Section 502(n)(3)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)(3)(A)) is 
amended by inserting ``(or when required under section 505(o)(4)(F))'' 
after ``except in extraordinary circumstances''.
    (c) Content of a New Drug Application.--Section 505(b)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended--
            (1) in subparagraph (F), by striking ``and''; and
            (2) in subparagraph (G), by striking the period and 
        inserting the following: ``, and (H) a proposed risk evaluation 
        and mitigation strategy as described under subsection (o).''.
    (d) Withdrawal or Suspension of Approval.--Section 505(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by 
adding at the end the following: ``The Secretary may withdraw the 
approval of an application submitted under subsection (b) or (j), or 
suspend the approval of such an application, as provided under this 
subsection, without first ordering the applicant to submit an 
assessment of the approved risk evaluation and mitigation strategy for 
the drug under subsection (o)(6)(B)(i)(V).''.
    (e) Drugs Subject to an Abbreviated New Drug Application.--Section 
505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(2)) is amended by adding at the end the following:
    ``(D) Risk Evaluation and Mitigation Strategy Requirement.--A drug 
that is the subject of an abbreviated new drug application under this 
subsection shall be subject to each element of the risk evaluation and 
mitigation strategy required under subsection (o) for the applicable 
listed drug, except for any post-approval clinical trial requirement 
described under paragraph (4)(E) of such subsection.''.

SEC. 104. RESOURCES.

    (a) User Fees.--Subparagraph (F) of section 735(6) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(6)) is amended to read as 
follows:
                    ``(F) Reviewing and implementing risk evaluation 
                and mitigation strategies, and collecting, developing, 
                and reviewing safety information on drugs, including 
                adverse event reports.''.
    (b) Public Accountability.--Section 505(a) of the Prescription Drug 
User Fee Amendments of 2002 (Subtitle A of title V of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (Public 
Law 107-188)) is amended by adding at the end the following:
            ``(3) Drug safety.--The recommendations under paragraph (1) 
        shall include estimates of the amounts by which the fee revenue 
        amounts for fiscal years 2008 through 2012 should be increased 
        to review and implement risk evaluation and mitigation 
        strategies, and to collect, develop, and review safety 
        information on drugs, including adverse event reports.''.
    (c) Strategic Plan for Information Technology.--Not later than 1 
year after the date of enactment of this title, the Secretary of Health 
and Human Services (referred to in this Act as the ``Secretary'') shall 
submit to the Committee on Health, Education, Labor, and Pensions and 
the Committee on Appropriations of the Senate and the Committee on 
Energy and Commerce and the Committee on Appropriations of the House of 
Representatives, a strategic plan on information technology that 
includes--
            (1) an assessment of the information technology 
        infrastructure, including data collection and data mining 
        systems, needed by the Food and Drug Administration to comply 
        with the requirements of this title (and the amendments made by 
        this title), to establish standards to achieve 
        interoperability, and to move toward electronic health records;
            (2) an assessment of the extent to which the current 
        information technology assets of the Food and Drug 
        Administration are sufficient to meet the needs assessment 
        under paragraph (1);
            (3) a plan for enhancing the information technology assets 
        of the Food and Drug Administration toward meeting the needs 
        assessment under paragraph (1); and
            (4) an assessment of additional resources needed to so 
        enhance the information technology assets of the Food and Drug 
        Administration.

SEC. 105. DRUG LABELING.

    (a) Accessible Repository of Drug Labeling.--Not later than the 
effective date of this title, the Secretary, through the Commissioner 
of Food and Drugs, and the Director of the National Institutes of 
Health, shall establish a searchable repository of structured, 
electronic product information, including the approved professional 
labeling and any required patient labeling of each drug approved under 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
or licensed under section 351 of the Public Health Service Act (42 
U.S.C. 262) in order to improve patient safety through accessible 
product information, support initiatives to improve patient care by 
better management of health care information, and provide standards for 
drug information. Such repository shall be made publicly accessible on 
the Internet website of the National Library of Medicine and through a 
link on the homepage of the Internet website of the Food and Drug 
Administration.
    (b) Posting Upon Approval.--The Secretary shall post in the 
repository under subsection (a) the approved professional labeling and 
any required patient labeling of a drug approved under such section 505 
or licensed under such section 351 not later than 21 days after the 
date the drug is approved, including in a supplemental application with 
respect to a labeling change.
    (c) Report.--The Secretary shall report annually to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor and Pensions of the Senate on the 
status of the repository under subsection (a), and on progress in 
posting structured electronic product information, including posting of 
information regarding drugs approved prior to the effective date of 
this title.
    (d) Medication Guides.--Not later than the effective date of this 
title, the Secretary, through the Commissioner of Food and Drugs, shall 
establish on the Internet website page for the repository under 
subsection (a) a link to a list of each drug, whether approved under 
such section 505 or licensed under such section 351, for which a 
Medication Guide, as provided for under part 208 of title 21, Code of 
Federal Regulations (or any successor regulations), is required.

SEC. 106. EFFECTIVE DATE AND APPLICABILITY.

    (a) Effective Date.--This title shall take effect 180 days after 
the date of enactment of this Act.
    (b) Drugs Deemed to Have Risk Evaluation and Mitigation 
Strategies.--
            (1) In general.--A drug that was approved before the 
        effective date of this title and for which there are in effect 
        on the effective date of this title restrictions on 
        distribution and use required under section 314.520 or section 
        600.42 of title 21, Code of Federal Regulations, or otherwise 
        agreed to by the applicant and the Secretary for such drug, 
        shall be deemed to have an approved risk evaluation and 
        mitigation strategy under such section 505(o) of the Federal 
        Food, Drug, and Cosmetic Act (as added by this title).
            (2) Risk evaluation and mitigation strategy.--The approved 
        risk evaluation and mitigation strategy deemed in effect for a 
        drug under paragraph (1) shall consist of the elements 
        described in subparagraphs (A) and (B) of paragraph (3) of such 
        section 505(o) and any other additional elements under 
        paragraphs (4) and (5) in effect for such drug on the effective 
        date of this title.
            (3) Notification.--Not later than 30 days after the 
        effective date of this title, the Secretary shall notify the 
        applicant for each drug described in paragraph (1)--
                    (A) that such drug is deemed to have an approved 
                risk evaluation and mitigation strategy pursuant to 
                such paragraph; and
                    (B) of the date, which shall be no earlier than 6 
                months after the applicant is so notified, by which the 
                applicant shall submit to the Secretary an assessment 
                of such approved strategy under paragraph (6)(B) of 
                such section 505(o).
            (4) Enforcement only after assessment and review.--Neither 
        the Secretary nor the Attorney General may seek to enforce a 
        requirement of a risk evaluation and mitigation strategy deemed 
        in effect under paragraph (1) before the Secretary has 
        completed review of, and acted on, the first assessment of such 
        strategy under such section 505(o).
    (c) Other Drugs Approved Before the Effective Date.--The Secretary, 
on a case-by-case basis, may require the applicant for a drug approved 
before the effective date of this title to which subsection (b) does 
not apply to submit a proposed risk evaluation and mitigation strategy 
in accordance with the timeframes provided for in subclause (III), 
(IV), or (V), as applicable, of paragraph (6)(B)(i) of such section 
505(o) if the Secretary determines that--
            (1) an element described under paragraph (3)(A) of such 
        section 505(o) may require modification; or
            (2) a standard for adding an element described in paragraph 
        (4) or (5) of such section 505(o) that is not in effect with 
        respect to such drug may apply to such drug.

    TITLE II--REAGAN-UDALL INSTITUTE FOR APPLIED BIOMEDICAL RESEARCH

SEC. 201. THE REAGAN-UDALL INSTITUTE FOR APPLIED BIOMEDICAL RESEARCH.

    (a) In General.--Chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end 
the following:

  ``Subchapter H--Establishment of Reagan-Udall Institute for Applied 
                          Biomedical Research

``SEC. 760. ESTABLISHMENT AND FUNCTIONS OF THE INSTITUTE.

    ``(a) In General.--There is established within the Food and Drug 
Administration an Institute to be known as the Reagan-Udall Institute 
for Applied Biomedical Research (referred to in this subchapter as the 
`Institute'). The Institute shall be headed by an Executive Director, 
appointed by the members of the Board of Directors under subsection 
(e).
    ``(b) Purpose of Institute.--The purpose of the Institute is to 
advance the Critical Path Initiative of the Food and Drug 
Administration to modernize medical product development, accelerate 
innovation, and enhance product safety by--
            ``(1) initiating, sponsoring, and organizing collaborative 
        and multidisciplinary research in the sciences of developing, 
        manufacturing, and evaluating the safety and effectiveness of 
        diagnostics, devices, biologics, and drugs;
            ``(2) ensuring the broad participation of academic, 
        government, and industrial researchers in the work of the 
        Institute; and
            ``(3) ensuring the maximum distribution and utilization of 
        the outcomes of such research, including through publication of 
        research results and dissemination of intellectual property 
        generated by the Institute.
    ``(c) Duties of the Institute.--The Institute shall--
            ``(1) establish goals and priorities relating to the 
        sciences of developing, manufacturing, and evaluating the 
        safety and effectiveness of diagnostics, devices, biologics, 
        and drugs;
            ``(2) identify unmet needs in the sciences of developing, 
        manufacturing, and evaluating the safety and effectiveness of 
        diagnostics, devices, biologics, and drugs;
            ``(3) in consultation with the National Institutes of 
        Health, assess existing and proposed Federal intramural and 
        extramural research and development programs relating to such 
        sciences, facilitate and encourage interagency coordination of 
        such programs, and participate in such programs relating to 
        such sciences, including--
                    ``(A) the identification and validation of 
                biomarkers for use in diagnostic, device, biologic, and 
                drug development;
                    ``(B) the development and validation of animal 
                models for human disease;
                    ``(C) pharmacogenomics and inter-individual 
                variability in drug and biologic response;
                    ``(D) the development of data analysis technology 
                for use in device, biologic, and drug development;
                    ``(E) advancing improvements to the design and 
                conduct of clinical trials;
                    ``(F) toxicological quality assessment 
                technologies;
                    ``(G) device manufacturing, design and materials 
                science;
                    ``(H) failure mode assessment for product 
                development;
                    ``(I) improving adverse event reporting and 
                analysis;
                    ``(J) bridging engineering data and clinical 
                performance for devices; and
                    ``(K) computer modeling;
            ``(4) award grants to, or enter into contracts or 
        cooperative agreements with, scientists and entities to advance 
        the purposes of the Institute pursuant to the processes 
        established in the by-laws under subsection (d)(2)(A);
            ``(5) release and publish information and data and, to the 
        extent practicable, license, distribute, and release material, 
        reagents, and techniques to maximize, promote, and coordinate 
        the availability of such material, reagents, and techniques for 
        use by the Food and Drug Administration, nonprofit 
        organizations, and academic and industrial researchers;
            ``(6) ensure that--
                    ``(A) action is taken as necessary to obtain 
                patents for inventions developed by the Institute or 
                with funds from the Institute;
                    ``(B) action is taken as necessary to enable the 
                licensing of inventions developed by the Institute or 
                with funds from the Institute; and
                    ``(C) executed licenses, memoranda of 
                understanding, material transfer agreements, contracts, 
                and other such instruments promote, to the maximum 
                extent practicable, the broadest conversion to 
                commercial and noncommercial applications of licensed 
                and patented inventions of the Institute consistent 
                with subsection (b)(3);
            ``(7) recruit scientists and hold or sponsor (in whole or 
        in part) meetings as appropriate to further the purposes of the 
        Institute;
            ``(8) provide objective clinical and scientific information 
        to the Food and Drug Administration and, upon request, to other 
        Federal agencies regarding how to ensure that regulatory policy 
        accommodates scientific advances;
            ``(9) conduct annual evaluations of research activities 
        that are supported by the Institute; and
            ``(10) carry out such other activities consistent with the 
        purposes of the Institute as the Board determines appropriate.
    ``(d) Board of Directors.--
            ``(1) Establishment.--
                    ``(A) In general.--The Institute shall have a Board 
                of Directors (referred to in this subchapter as the 
                `Board'), which shall be composed of ex officio and 
                appointed members in accordance with this subsection. 
                All appointed members of the Board shall be voting 
                members.
                    ``(B) Ex officio members.--The ex officio members 
                of the Board shall be--
                            ``(i) the immediate past Chair of Board of 
                        Directors of the Institute;
                            ``(ii) the Commissioner of Food and Drugs; 
                        and
                            ``(iii) the Director of the National 
                        Institutes of Health.
                    ``(C) Appointed members.--
                            ``(i) In general.--The ex officio members 
                        of the Board under subparagraph (B) shall, by 
                        majority vote, appoint to the Board 12 
                        individuals. Of such appointed members--
                                    ``(I) 4 shall be representatives of 
                                the general pharmaceutical, device, and 
                                biotechnology industries;
                                    ``(II) 3 shall be representatives 
                                of academic research organizations;
                                    ``(III) 2 shall be representatives 
                                of Government agencies, including the 
                                Food and Drug Administration and the 
                                National Institutes of Health;
                                    ``(IV) 2 shall be representatives 
                                of patient advocacy organizations; and
                                    ``(V) 1 shall be a representative 
                                of health care providers.
                            ``(ii) Requirement.--The ex officio members 
                        shall ensure the Board membership includes 
                        individuals with expertise in clinical 
                        pharmacology, biomedical informatics, 
                        information management, product safety, process 
                        improvement and pharmaceutical sciences, and 
                        medical device and biomedical engineering.
            ``(2) Duties of board.--The Board shall--
                    ``(A) establish by-laws for the Institute that--
                            ``(i) are published in the Federal Register 
                        and available for public comment;
                            ``(ii) establish licensing, distribution, 
                        and publication policies that support the 
                        widest and least restrictive use by the public 
                        of information and inventions developed by the 
                        Institute or with Institute funds to carry out 
                        the duties described in paragraphs (5) and (6) 
                        of subsection (c);
                            ``(iii) specify criteria and processes for 
                        the review of proposals and awarding of grants 
                        and contracts that include peer review and that 
                        are substantially consistent with those 
                        established by other government organizations, 
                        such as the National Institutes of Health and 
                        the National Science Foundation;
                            ``(iv) specify a process for annual Board 
                        review of the operations of the Institute; and
                            ``(v) establish specific duties of the 
                        Executive Director;
                    ``(B) identify and prioritize the scientific needs 
                that may be effectively and uniquely addressed by the 
                Institute;
                    ``(C) prioritize and provide overall direction to 
                the research activities of the Institute;
                    ``(D) evaluate the performance of the Executive 
                Director; and
                    ``(E) carry out any other necessary activities 
                regarding the functioning of the Institute.
            ``(3) Additional board functions.--
                    ``(A) In general.--The Board may establish 1 or 
                more Critical Path Institutes to conduct 
                multidisciplinary and collaborative research, 
                education, and outreach, and to modernize the sciences 
                of developing, manufacturing, and evaluating the safety 
                and effectiveness of diagnostics, devices, biologics, 
                and drugs.
                    ``(B) Eligibility.--To be eligible to host a 
                Critical Path Institute described in subparagraph (A), 
                an entity shall--
                            ``(i) be a State or local government, 
                        institution of higher education, or nonprofit 
                        entity with demonstrated ability, personnel, 
                        and clinical and other technical expertise to 
                        undertake the duties consistent with the 
                        activities in subparagraph (A); and
                            ``(ii) submit to the Board an application 
                        at such time, in such manner, and containing 
                        such information as the Board may require.
            ``(4) Chair.--The ex officio members of the Board under 
        paragraph (1)(B) shall designate an appointed member of the 
        Board to serve as the Chair of the Board.
            ``(5) Terms and vacancies.--
                    ``(A) Term.--The term of office of each member of 
                the Board appointed under paragraph (1)(C) shall be 4 
                years, except that the terms of offices for the initial 
                appointed members of the Board shall expire on a 
                staggered basis as determined by the ex officio 
                members.
                    ``(B) Vacancy.--Any vacancy in the membership of 
                the Board--
                            ``(i) shall not affect the power of the 
                        remaining members to execute the duties of the 
                        Board; and
                            ``(ii) shall be filled by appointment by 
                        the ex officio members of the Board in the 
                        manner described under paragraph (1)(C)(i).
                    ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed by the ex officio members 
                of the Board in the manner described under paragraph 
                (1)(C)(i) to fill the resulting vacancy shall be 
                appointed for the remainder of the term of the 
                predecessor of the individual.
                    ``(D) Serving past term.--A member of the Board may 
                continue to serve after the expiration of the term of 
                the member until a successor is appointed.
            ``(6) Compensation.--Members of the Board may not receive 
        compensation for service on the Board. Such members may be 
        reimbursed for travel, subsistence, and other necessary 
        expenses incurred in carrying out the duties of the Board, as 
        set forth in the bylaws issued by the Board.
    ``(e) Executive Director.--
            ``(1) In general.--The Board shall appoint an Executive 
        Director who shall serve at the pleasure of the Board. The 
        Executive Director shall be responsible for the day-to-day 
        operations of the Institute and shall have such specific duties 
        and responsibilities as the Board shall prescribe.
            ``(2) Compensation.--The compensation of the Executive 
        Director shall be fixed by the Board but shall not be greater 
        than the compensation of the Commissioner of Food and Drugs.
    ``(f) Administrative Powers.--In carrying out this subchapter, the 
Board, acting through the Executive Director, may--
            ``(1) hire, promote, compensate, and discharge 1 or more 
        officers, employees, and agents, as may be necessary, and 
        define their duties;
            ``(2) prescribe the manner in which--
                    ``(A) real or personal property of the Institute is 
                acquired, held, and transferred;
                    ``(B) general operations of the Institute are to be 
                conducted; and
                    ``(C) the privileges granted to the Board by law 
                are exercised and enjoyed;
            ``(3) with the consent of the applicable executive 
        department or independent agency, use the information, 
        services, and facilities of such department or agencies in 
        carrying out this section;
            ``(4) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            ``(5) hold, administer, invest, and spend any gift, devise, 
        or bequest of real or personal property made to the Institute 
        under subsection (g);
            ``(6) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Board considers 
        appropriate to conduct the activities of the Institute;
            ``(7) appoint other groups of advisors as may be determined 
        necessary to carry out the functions of the Institute; and
            ``(8) exercise other powers as set forth in this section, 
        and such other incidental powers as are necessary to carry out 
        its powers, duties, and functions in accordance with this 
        subchapter.
    ``(g) Acceptance of Funds From Other Sources.--The Executive 
Director may accept on behalf of the Institute, any funds, gifts, 
devises, or bequests of real or personal property made to the Institute 
from sources outside the Food and Drug Administration, including 
private entities, for the purposes of carrying out the duties of the 
Institute.
    ``(h) Annual Reports.--
            ``(1) Reports to institute.--Any recipient of a grant, 
        contract, or cooperative agreement from the Institute under 
        this section shall submit to the Institute a report on an 
        annual basis for the duration of such grant, contract, or 
        cooperative agreement, that describes the activities carried 
        out under such grant, contract, or cooperative agreement.
            ``(2) Report to congress.--Beginning with fiscal year 2008, 
        the Executive Director shall submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives an annual report that--
                    ``(A) describes the activities of the Institute and 
                of the recipients of a grant, contract, or cooperative 
                agreement under this section, including the practical 
                impact of the Institute on medical product development, 
                with emphasis on progress made by the Food and Drug 
                Administration in incorporating Critical Path 
                priorities to modernize medical product development, 
                accelerate innovation, and enhance product safety;
                    ``(B) provides a specific accounting of the source 
                of all funds used by the Institute to carry out such 
                activities; and
                    ``(C) describes how such funds were used by the 
                Institute.
    ``(i) Separation of Funds.--The Executive Director shall ensure 
that the funds received from the Treasury are held in separate accounts 
from funds received from private entities under subsection (g).
    ``(j) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        $20,000,000 for each of fiscal years 2008 through 2013 to carry 
        out this section, section 761, and section 762.
            ``(2) Limitation.--From amounts appropriated for a fiscal 
        year under subparagraph (A), the Secretary shall use not less 
        than $1,200,000 to carry out subsections (a), (b), and (d) 
        through (i).''.
    (b) Employees From Other Federal Agencies.--Chapter VII (21 U.S.C. 
380 et seq.) (as amended by subsection (a)) is amended by adding at the 
end the following:

``SEC. 761. ACCEPTING EMPLOYEES FROM OTHER FEDERAL AGENCIES.

    ``(a) Collaboration With Other Agencies.--To carry out the purposes 
of the Institute, the Secretary, acting through the Commissioner of 
Food and Drugs and in consultation with the Executive Director of the 
Institute, may collaborate with other Federal agencies and accept the 
services of employees from those agencies without reimbursement to 
those agencies.
    ``(b) Detail of Government Employees.--Not more than 5 Federal 
Government employees may be detailed to the Institute at any time for a 
period not to exceed 6 years for each such employee, and such detail 
shall be without civil service status or privilege. Such employees 
shall abide by the statutory, regulatory, ethical, and procedural 
standards applicable to employees of the Food and Drug Administration.
    ``(c) Procurement of Temporary and Intermittent Services.--The 
Executive Director may procure temporary and intermittent services 
under section 3109(b) of title 5, United States Code, at rates for 
individuals which do not exceed the daily equivalent of the annual rate 
of basic pay prescribed for level V of the Executive Schedule under 
section 5316 of such title.
    ``(d) No Additional Liability.--Nothing in this section adds to any 
liability that the United States may have under chapter 171 of title 
28, United States Code (commonly known as the Federal Tort Claims 
Act).''.
    (c) Other Institute Provisions.--Chapter VII (21 U.S.C. 371 et 
seq.) (as amended by subsection (b)) is amended by adding at the end 
the following:

``SEC. 762. LOCATION OF INSTITUTE.

    ``(a) In General.--The Institute shall, if practicable, be located 
not more than 20 miles from the District of Columbia.
    ``(b) Use of Space.--The Secretary shall consult with the 
Administrator of General Services to ensure the most cost-efficient 
arrangement for the leasing or purchase of real property for adequate 
facilities which, if practicable, shall be located at the Food and Drug 
Administration, to meet the needs of the Institute in carrying out this 
subchapter.''.
    (d) Recovery and Retention of Fees for FOIA Requests.--Chapter VII 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as 
amended by subsection (c)) is amended by adding at the end the 
following:

``SEC. 763. RECOVERY AND RETENTION OF FEES FOR FREEDOM OF INFORMATION 
              REQUESTS TO THE INSTITUTE.

    ``(a) In General.--The Secretary, acting through the Commissioner 
of Food and Drugs, may--
            ``(1) set and charge fees, in accordance with section 
        552(a)(4)(A) of title 5, United States Code, to recover all 
        reasonable costs incurred in processing requests made under 
        section 552 of title 5, United States Code, for records 
        obtained or created by the Institute under this Act or any 
        other Federal law for which responsibility for administration 
        has been delegated to the Institute by the Secretary;
            ``(2) retain all fees charged for such requests; and
            ``(3) establish an accounting system and procedures to 
        control receipts and expenditures of fees received under this 
        section.
    ``(b) Use of Fees.--The Secretary and the Commissioner of Food and 
Drugs shall not use fees received under this section for any purpose 
other than funding the processing of requests described in subsection 
(a)(1). Such fees shall not be used to reduce the amount of funds made 
available to carry out other provisions of this Act.
    ``(c) Waiver of Fees.--Nothing in this section shall supersede the 
right of a requester to obtain a waiver of fees pursuant to section 
552(a)(4)(A) of title 5, United States Code.''.

                       TITLE III--CLINICAL TRIALS

SEC. 301. CLINICAL TRIAL REGISTRY DATABASE AND CLINICAL TRIAL RESULTS 
              DATABASE.

    (a) In General.--Section 402(j) of the Public Health Service Act 
(42 U.S.C. 282(j)) is amended to read as follows:
    ``(j) Clinical Trial Registry Database; Clinical Trial Results 
Database.--
            ``(1) Definitions; requirement.--
                    ``(A) Definitions.--In this subsection:
                            ``(i) Clinical trial information.--The term 
                        `clinical trial information' means those data 
                        elements that are necessary to complete an 
                        entry in the clinical trial registry database 
                        under paragraph (2) or the clinical trial 
                        results database under paragraph (3), as 
                        applicable.
                            ``(ii) Completion date.--The term 
                        `completion date' means, with respect to a 
                        clinical trial, the date on which the last 
                        patient enrolled in the clinical trial has 
                        completed his or her last medical visit of the 
                        clinical trial (known as last patient last 
                        visit), whether the clinical trial concluded 
                        according to the prespecified protocol plan or 
                        was terminated.
                            ``(iii) Drug.--The term `drug' means a drug 
                        as defined in section 201(g) of the Federal 
                        Food, Drug, and Cosmetic Act or a biological 
                        product as defined in section 351 of this Act.
                            ``(iv) Responsible party.--The term 
                        `responsible party', with respect to a clinical 
                        trial of a drug, means the sponsor of the 
                        clinical trial or the principal investigator of 
                        such clinical trial if so designated by such 
                        sponsor.
                    ``(B) Requirement.--The Secretary shall develop a 
                mechanism by which--
                            ``(i) the responsible party for each 
                        applicable clinical trial shall submit the 
                        identity and contact information of such 
                        responsible party to the Secretary at the time 
                        of submission of clinical trial information 
                        under paragraph (2); and
                            ``(ii) other Federal agencies may identify 
                        the responsible party for an applicable 
                        clinical trial.
            ``(2) Clinical trial registry database.--
                    ``(A) Applicable clinical trial.--
                            ``(i) In general.--For purposes of this 
                        paragraph the term `applicable clinical trial' 
                        means--
                                    ``(I) an interventional clinical 
                                trial conducted before the drug is 
                                approved under section 505 of the 
                                Federal Food, Drug, and Cosmetic Act or 
                                licensed under section 351 of this Act 
                                that is--
                                            ``(aa) a therapeutic or 
                                        chemopreventive exploratory 
                                        clinical trial to verify the 
                                        efficacy and establish 
                                        appropriate doses for the drug; 
                                        or
                                            ``(bb) a therapeutic or 
                                        chemopreventive confirmatory 
                                        clinical trial;
                                    ``(II) a clinical trial conducted 
                                after the drug is approved under such 
                                section 505 or licensed under such 
                                section 351; or
                                    ``(III) a pharmacokinetic study to 
                                support a pediatric indication for the 
                                drug.
                            ``(ii) Exception.--A clinical trial under 
                        clause (i)(I)(aa) does not include--
                                    ``(I) an exploratory clinical trial 
                                that is intended solely to assess 
                                safety or solely to evaluate 
                                pharmacokinetics; or
                                    ``(II) an observational study.
                    ``(B) Establishment.--
                            ``(i) In general.--To enhance patient 
                        enrollment and provide a mechanism to track 
                        subsequent progress of clinical trials, the 
                        Secretary, acting through the Director of NIH, 
                        shall establish and administer a clinical trial 
                        registry database in accordance with this 
                        subsection (referred to in this subsection as 
                        the `registry database'). The Director of NIH 
                        shall ensure that the registry database is made 
                        publicly available through the Internet.
                            ``(ii) Content.--The Secretary shall 
                        promulgate regulations for the submission to 
                        the registry database of clinical trial 
                        information that--
                                    ``(I) conforms to the International 
                                Clinical Trials Registry Platform trial 
                                registration data set of the World 
                                Health Organization;
                                    ``(II) if the drug is not approved 
                                under section 505 of the Federal Food, 
                                Drug, and Cosmetic Act or licensed 
                                under section 351 of this Act, 
                                specifies whether or not there is a 
                                mechanism to access the drug outside of 
                                the clinical trial for those who do not 
                                qualify for enrollment in the clinical 
                                trial and how to obtain information 
                                about such a mechanism; and
                                    ``(III) requires the inclusion of 
                                such other data elements to the 
                                registry database as appropriate.
                    ``(C) Format and structure.--
                            ``(i) Searchable categories.--The Director 
                        of NIH shall ensure that the public may search 
                        the entries in the registry database by--
                                    ``(I)(aa) the indication being 
                                studied in the clinical trial, using 
                                Medical Subject Headers (MeSH) 
                                descriptors; or
                                    ``(bb) the safety issue being 
                                studied in the clinical trial;
                                    ``(II) enrollment status of the 
                                clinical trial; and
                                    ``(III) the sponsor of the clinical 
                                trial.
                            ``(ii) Format.--The Director of the NIH 
                        shall ensure that the registry database is 
                        easily used by patients, and that entries are 
                        easily compared.
                    ``(D) Data submission.--The responsible party for 
                an applicable clinical trial shall submit to the 
                Director of NIH for inclusion in the registry database 
                the clinical trial information described in 
                subparagraph (B)(ii).
                    ``(E) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this paragraph shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of requiring clinical trial 
                        information with respect to an applicable 
                        clinical trial to include information from any 
                        source other than such clinical trial.
                    ``(F) Changes in clinical trial status.--
                            ``(i) Enrollment.--The responsible party 
                        for an applicable clinical trial shall update 
                        the enrollment status not later than 30 days 
                        after the enrollment status of such clinical 
                        trial changes.
                            ``(ii) Completion.--The responsible party 
                        for an applicable clinical trial shall report 
                        to the Director of NIH that such clinical trial 
                        is complete not later than 30 days after the 
                        completion date of the clinical trial.
                    ``(G) Timing of submission.--The clinical trial 
                information for an applicable clinical trial required 
                to be submitted under this paragraph shall be submitted 
                not later than 14 days after the first patient is 
                enrolled in such clinical trial.
            ``(3) Clinical trials results database.--
                    ``(A) Applicable clinical trial.--
                            ``(i) In general.--For purposes of this 
                        paragraph, the term `applicable clinical trial' 
                        means--
                                    ``(I) an interventional clinical 
                                trial conducted before the drug is 
                                approved under section 505 of the 
                                Federal Food, Drug, and Cosmetic Act or 
                                licensed under section 351 of this Act 
                                that is--
                                            ``(aa) a therapeutic or 
                                        chemopreventive confirmatory 
                                        clinical trial;
                                            ``(bb) a clinical trial for 
                                        a drug approved as a fast-track 
                                        product under section 506 of 
                                        the Federal Food, Drug, and 
                                        Cosmetic Act, if such clinical 
                                        trial is used to form the 
                                        primary basis of an efficacy 
                                        claim for such drug; or
                                            ``(cc) if required by the 
                                        Secretary under subparagraph 
                                        (G)(i), a clinical trial 
                                        described in paragraph 
                                        (2)(A)(i)(I)(aa);
                                    ``(II) a clinical trial completed 
                                after the drug is approved under such 
                                section 505 or licensed under such 
                                section 351; or
                                    ``(III) a pharmacokinetic study to 
                                support a pediatric indication for the 
                                drug.
                            ``(ii) Exception.--A clinical trial under 
                        clause (i) does not include--
                                    ``(I) an exploratory clinical trial 
                                that is intended solely to assess 
                                safety or solely to evaluate 
                                pharmacokinetics; or
                                    ``(II) an observational study.
                    ``(B) Establishment.--To ensure that results of 
                clinical trials are made public and that patients and 
                providers have current information regarding the 
                results of clinical trials, the Secretary, acting 
                through the Director of NIH, shall establish and 
                administer a clinical trial results database in 
                accordance with this subsection (referred to in this 
                subsection as the `results database').
                    ``(C) Searchable categories.--The Director of NIH 
                shall ensure that the public may search the entries in 
                the results database by--
                            ``(i)(I) the indication studied in the 
                        clinical trial, using Medical Subject Headers 
                        (MeSH) descriptors; or
                            ``(II) the safety issue studied in the 
                        clinical trial;
                            ``(ii) whether an application for the 
                        tested indication is approved, pending 
                        approval, withdrawn, or not submitted;
                            ``(iii) the phase of the clinical trial;
                            ``(iv) the name of the drug that is the 
                        subject of the clinical trial; and
                            ``(v) within the documents described in 
                        subclauses (II) and (III) of subparagraph 
                        (D)(ii)--
                                    ``(I) the sponsor of the clinical 
                                trial; and
                                    ``(II) each financial sponsor of 
                                the clinical trial.
                    ``(D) Contents.--
                            ``(i) In general.--The responsible party 
                        for an applicable clinical trial shall submit 
                        to the Director of NIH for inclusion in the 
                        results database the clinical trial information 
                        described in clause (ii).
                            ``(ii) Required elements.--In submitting 
                        clinical trial information for an applicable 
                        clinical trial to the Director of NIH for 
                        inclusion in the results database, the 
                        responsible party shall include, with respect 
                        to such clinical trial, the following 
                        information:
                                    ``(I) The information described in 
                                clauses (i) through (iv) of 
                                subparagraph (C).
                                    ``(II) A non-promotional summary 
                                document that is written in non-
                                technical, understandable language for 
                                patients that includes the following:
                                            ``(aa) The purpose of the 
                                        clinical trial.
                                            ``(bb) The sponsor of the 
                                        clinical trial.
                                            ``(cc) A point of contact 
                                        for information about the 
                                        clinical trial.
                                            ``(dd) A description of the 
                                        patient population tested in 
                                        the clinical trial.
                                            ``(ee) A general 
                                        description of the clinical 
                                        trial and results, including a 
                                        description of and the reasons 
                                        for any changes in the clinical 
                                        trial design that occurred 
                                        since the date of submission of 
                                        clinical trial information for 
                                        inclusion in the registry 
                                        database established under 
                                        paragraph (2) and a description 
                                        of any significant safety 
                                        information.
                                    ``(III) A non-promotional summary 
                                document that is technical in nature 
                                that includes the following:
                                            ``(aa) The purpose of the 
                                        clinical trial.
                                            ``(bb) The sponsor of the 
                                        clinical trial.
                                            ``(cc) Each financial 
                                        sponsor of the clinical trial.
                                            ``(dd) A point of contact 
                                        for scientific information 
                                        about the clinical trial.
                                            ``(ee) A description of the 
                                        patient population tested in 
                                        the clinical trial.
                                            ``(ff) A general 
                                        description of the clinical 
                                        trial and results, including a 
                                        description of and the reasons 
                                        for any changes in the clinical 
                                        trial design that occurred 
                                        since the date of submission of 
                                        clinical trial information for 
                                        the clinical trial in the 
                                        registry database established 
                                        under paragraph (2).
                                            ``(gg) Summary data 
                                        describing the results, 
                                        including--

                                                    ``(AA) whether the 
                                                primary endpoint was 
                                                achieved, including 
                                                relevant statistics;

                                                    ``(BB) an 
                                                assessment of any 
                                                secondary endpoints, if 
                                                applicable, including 
                                                relevant statistics; 
                                                and

                                                    ``(CC) any 
                                                significant safety 
                                                information, including 
                                                a summary of the 
                                                incidence of serious 
                                                adverse events observed 
                                                in the clinical trial 
                                                and a summary of the 
                                                most common adverse 
                                                events observed in the 
                                                clinical trial and the 
                                                frequencies of such 
                                                events.

                                    ``(IV) A link to available peer-
                                reviewed publications based on the 
                                results of the clinical trial, if any.
                                    ``(V) The completion date of the 
                                clinical trial.
                                    ``(VI) A link to the Internet web 
                                posting of any adverse regulatory 
                                actions taken by the Food and Drug 
                                Administration, such as a warning 
                                letter, that was substantively based on 
                                the clinical trial design, outcome, or 
                                representation made by the applicant 
                                about the design or outcome of the 
                                clinical trial.
                    ``(E) Timing.--A responsible party shall submit to 
                the Director of NIH for inclusion in the results 
                database clinical trial information for an applicable 
                clinical trial not later than 1 year after the 
                completion date of the clinical trial as reported under 
                paragraph (2)(F)(ii).
                    ``(F) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this paragraph shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of requiring clinical trial 
                        information with respect to an applicable 
                        clinical trial to include information from any 
                        source other than such clinical trial.
                    ``(G) Inclusion of earlier clinical trials.--
                            ``(i) In general.--The Secretary may, 
                        subject to clause (ii), require through 
                        rulemaking the submission of clinical trial 
                        information for the clinical trials described 
                        in paragraph (2)(A)(i)(I)(aa) to the Director 
                        of NIH for inclusion in the results database.
                            ``(ii) Conditions for requiring inclusion 
                        of earlier trials.--The Secretary may 
                        promulgate regulations pursuant to clause (i) 
                        if--
                                    ``(I) the Comptroller General of 
                                the United States has submitted to the 
                                Secretary the report described under 
                                clause (iii); and
                                    ``(II) such report recommends the 
                                inclusion in the results database of 
                                clinical trial information for the 
                                clinical trials described under 
                                paragraph (2)(A)(i)(I)(aa).
                            ``(iii) Study by gao.--Not earlier than 2 
                        years after the results database has been 
                        established, the Comptroller General of the 
                        United States shall initiate a report that--
                                    ``(I) evaluates the operation of 
                                the database, including with respect to 
                                cost, burden on drug sponsors and 
                                agencies, and the value to patients and 
                                health care providers of inclusion in 
                                the results database of clinical trial 
                                information with respect to clinical 
                                trials described in paragraph 
                                (2)(A)(i)(I)(aa);
                                    ``(II) recommends whether or not 
                                clinical trial information for such 
                                clinical trials should be included in 
                                the results database;
                                    ``(III) if the recommendation under 
                                subclause (II) is to include the 
                                clinical trial information for such 
                                clinical trials in the results 
                                database, recommends whether such 
                                information should be included in the 
                                same format as the clinical trial 
                                information of other applicable 
                                clinical trials, or if modifications 
                                are necessary;
                                    ``(IV) provides recommendations for 
                                any modifications described under 
                                subclause (III); and
                                    ``(V) is submitted to the Committee 
                                on Health, Education, Labor, and 
                                Pensions of the Senate, the Committee 
                                on Energy and Commerce of the House of 
                                Representatives, and the Secretary.
                    ``(H) Change in regulatory status.--The responsible 
                party for an applicable clinical trial shall update the 
                regulatory status submitted under subparagraph (C)(ii) 
                of a drug that is the subject of an applicable clinical 
                trial within 30 days of a change in such status.
                    ``(I) Public availability of results.--
                            ``(i) Pre-approval studies.--Except as 
                        provided in clause (iv), with respect to an 
                        applicable clinical trial that is completed 
                        before the drug is initially approved under 
                        section 505 of the Federal Food, Drug, and 
                        Cosmetic Act or initially licensed under 
                        section 351 of this Act, the Director of NIH 
                        shall make publicly available on the results 
                        database the clinical trial information 
                        submitted for such clinical trial not later 
                        than 30 days after--
                                    ``(I) the drug is approved under 
                                such section 505 or licensed under such 
                                section 351; or
                                    ``(II) the Secretary issues a not 
                                approvable letter for the drug under 
                                such section 505 or such section 351.
                            ``(ii) Post-approval studies.--Except as 
                        provided in clauses (iii) and (iv), with 
                        respect to an applicable clinical trial that is 
                        completed after the drug is initially approved 
                        under such section 505 or initially licensed 
                        under such section 351, the Director of NIH 
                        shall make publicly available on the results 
                        database the clinical trial information 
                        submitted for such clinical trial not later 
                        than 30 days after the date of such submission.
                            ``(iii) Seeking approval of a new use for 
                        the drug.--
                                    ``(I) In general.--If the 
                                manufacturer of the drug is the sponsor 
                                or a financial sponsor of the 
                                applicable clinical trial, and such 
                                manufacturer certifies to the Director 
                                of NIH that such manufacturer has 
                                filed, or will file within 1 year, an 
                                application seeking approval under such 
                                section 505 or licensing under such 
                                section 351 for the use studied in such 
                                clinical trial (which use is not 
                                included in the labeling of the 
                                approved drug), then the Director of 
                                NIH shall make publicly available on 
                                the results database the clinical trial 
                                information submitted for such clinical 
                                trial on the earlier of the date that 
                                is 30 days after the date--
                                            ``(aa) the application is 
                                        approved under such section 505 
                                        or licensed such section 351;
                                            ``(bb) the Secretary issues 
                                        a not approvable letter for the 
                                        application under such section 
                                        505 or such section 351; or
                                            ``(cc) the application 
                                        under such section 505 or such 
                                        section 351 is withdrawn.
                                    ``(II) Limitation on 
                                certification.--A manufacturer shall 
                                not make a certification under 
                                subclause (I) with respect to an 
                                applicable clinical trial unless the 
                                manufacturer makes such a certification 
                                with respect to each applicable 
                                clinical trial that is required to be 
                                submitted in an application for 
                                approval of the use studied in the 
                                clinical trial involved.
                                    ``(III) 2 year limitation.--The 
                                clinical trial information subject to 
                                subclause (I) shall be made publicly 
                                available on the results database on 
                                the date that is 2 years after the date 
                                that the clinical trial information was 
                                required to be submitted to the 
                                Director of NIH if a regulatory action 
                                referred to in item (aa), (bb), or (cc) 
                                of subclause (I) has not occurred by 
                                such date.
                            ``(iv) Seeking publication.--
                                    ``(I) In general.--If the principal 
                                investigator of the applicable clinical 
                                trial is seeking publication in a peer-
                                reviewed biomedical journal of a 
                                manuscript based on the results of the 
                                clinical trial and the responsible 
                                party so certifies to the Director of 
                                NIH--
                                            ``(aa) the responsible 
                                        party shall notify the Director 
                                        of NIH of the publication date 
                                        of such manuscript not later 
                                        than 15 days after such date; 
                                        and
                                            ``(bb) the Director of NIH 
                                        shall make publicly available 
                                        on the results database the 
                                        clinical trial information 
                                        submitted for such clinical 
                                        trial on the date that is 30 
                                        days after the publication date 
                                        of such manuscript.
                                    ``(II) Limitation.--The clinical 
                                trial information subject to subclause 
                                (I) shall be made publicly available on 
                                the results database on the date that 
                                is 2 years after the date that the 
                                clinical trial information was required 
                                to be submitted to the Director of NIH 
                                if the manuscript referred to in such 
                                subclause has not been published by 
                                such date.
                    ``(J) Verification of submission prior to public 
                availability.--In the case of clinical trial 
                information that is submitted under this paragraph, but 
                is not made publicly available pending either 
                regulatory action or publication under clause (iii) or 
                (iv) of subparagraph (I), as applicable, the Director 
                of NIH shall respond to inquiries from other Federal 
                agencies and peer-reviewed journals to confirm that 
                such clinical trial information has been submitted but 
                has not yet been made publicly available on the results 
                database.
            ``(4) Coordination and compliance.--
                    ``(A) Clinical trials supported by grants from 
                federal agencies.--
                            ``(i) In general.--No Federal agency may 
                        release funds under a research grant to a 
                        person who has not complied with paragraphs (2) 
                        and (3) for any applicable clinical trial for 
                        which such person is the responsible party.
                            ``(ii) Grants from certain federal 
                        agencies.--If an applicable clinical trial is 
                        funded in whole or in part by a grant from the 
                        National Institutes of Health, the Agency for 
                        Healthcare Research and Quality, or the 
                        Department of Veterans Affairs, any grant or 
                        progress report forms required under such grant 
                        shall include a certification that the 
                        responsible party has made all required 
                        submissions to the Director of NIH under 
                        paragraphs (2) and (3).
                            ``(iii) Verification by federal agencies.--
                        The heads of the agencies referred to in clause 
                        (ii), as applicable, shall verify that the 
                        clinical trial information for each applicable 
                        clinical trial for which a grantee is the 
                        responsible party has been submitted under 
                        paragraph (2) and (3), as applicable, before 
                        releasing funding for a grant to such grantee.
                            ``(iv) Notice and opportunity to remedy.--
                        If the head of an agency referred to in clause 
                        (ii), as applicable, verifies that a grantee 
                        has not submitted clinical trial information as 
                        described in clause (iii), such agency head 
                        shall provide notice to such grantee of such 
                        non-compliance and allow such grantee 30 days 
                        to correct such non-compliance and submit the 
                        required clinical trial information.
                            ``(v) Consultation with other federal 
                        agencies.--The Secretary shall--
                                    ``(I) consult with other agencies 
                                that conduct human studies in 
                                accordance with part 46 of title 45, 
                                Code of Federal Regulations (or any 
                                successor regulations), to determine if 
                                any such studies are applicable 
                                clinical trials under paragraph (2) or 
                                (3); and
                                    ``(II) develop with such agencies 
                                procedures comparable to those 
                                described in clauses (ii), (iii), and 
                                (iv) to ensure that clinical trial 
                                information for such applicable 
                                clinical trials is submitted under 
                                paragraphs (2) and (3).
                    ``(B) Coordination of registry database and results 
                database.--
                            ``(i) In general.--Each entry in the 
                        registry database under paragraph (2) shall 
                        include a link to the corresponding entry in 
                        the results database under paragraph (3).
                            ``(ii) Missing entries.--
                                    ``(I) In general.--If, based on a 
                                review of the entries in the registry 
                                database under paragraph (2), the 
                                Director of NIH determines that a 
                                responsible party has failed to submit 
                                required clinical trial information to 
                                the results database under paragraph 
                                (3), the Director of NIH shall inform 
                                the responsible party involved of such 
                                failure and permit the responsible 
                                party to correct the failure within 30 
                                days.
                                    ``(II) Failure to correct.--If the 
                                responsible party does not correct a 
                                failure to submit required clinical 
                                trial information within the 30-day 
                                period described under subclause (I), 
                                the Director of NIH shall report such 
                                non-compliance to the scientific peer 
                                review committees of the Federal 
                                research agencies and to the Office of 
                                Human Research Protections.
                                    ``(III) Public notice of failure to 
                                correct.--The Director of NIH shall 
                                include in the clinical trial registry 
                                database entry and the clinical trial 
                                results database entry for each such 
                                clinical trial a notice of any 
                                uncorrected failure to submit required 
                                clinical trial information and shall 
                                provide that the public may easily 
                                search for such entries.
                    ``(C) Action on applications.--
                            ``(i) Verification prior to filing.--The 
                        Secretary, acting through the Commissioner of 
                        Food and Drugs, shall verify that the clinical 
                        trial information required under paragraphs (2) 
                        and (3) for an applicable clinical trial is 
                        submitted pursuant to such applicable 
                        paragraph--
                                    ``(I) when considering a drug for 
                                an exemption under section 505(i) of 
                                the Federal Food, Drug, and Cosmetic 
                                Act, including as the drug progresses 
                                through the clinical trials described 
                                under paragraph (2)(A)(i); and
                                    ``(II) prior to filing an 
                                application under section 505 of the 
                                Federal Food, Drug, and Cosmetic Act or 
                                under section 351 of this Act that 
                                includes information from such clinical 
                                trial.
                            ``(ii) Notification.--If the responsible 
                        party has not submitted such clinical trial 
                        information, the Secretary shall notify the 
                        applicant and the responsible party of such 
                        non-compliance and require submission of such 
                        results within 30 days.
                            ``(iii) Refusal to file.--If the 
                        responsible party does not remedy such non-
                        compliance within 30 days of receipt of 
                        notification under clause (ii), the Secretary 
                        shall refuse to file such application.
                    ``(D) Content review.--
                            ``(i) In general.--To assure that the 
                        summary documents described in paragraph (3)(D) 
                        are non-promotional, and are not false or 
                        misleading in any particular under paragraph 
                        (3)(F), the Secretary shall compare such 
                        documents to the results data of the clinical 
                        trial for a representative sample of applicable 
                        clinical trials by--
                                    ``(I) acting through the 
                                Commissioner of Food and Drugs to 
                                examine the results data for such 
                                clinical trials submitted to Secretary 
                                when such data are submitted--
                                            ``(aa) for review as part 
                                        of an application under section 
                                        505 of the Federal Food, Drug, 
                                        and Cosmetic Act or under 
                                        section 351 of this Act; or
                                            ``(bb) in an annual status 
                                        report on the drug under such 
                                        application;
                                    ``(II) acting through the Inspector 
                                General of the Department of Health and 
                                Human Services and with the Federal 
                                agency that funds such clinical trial 
                                in whole or in part by a grant to 
                                examine the results data for such 
                                clinical trials; and
                                    ``(III) acting through inspections 
                                under section 704 of the Federal Food, 
                                Drug, and Cosmetic Act to examine 
                                results data for such clinical trials 
                                not described in subclause (I) or (II).
                            ``(ii) Notice of non-compliance.--If the 
                        Secretary or Inspector General of the 
                        Department of Health and Human Services 
                        determines that the clinical trial information 
                        submitted in such a summary document is 
                        promotional, or false or misleading in any 
                        particular, the Secretary shall notify the 
                        responsible party and give such party an 
                        opportunity to remedy such non-compliance by 
                        submitting the required revised clinical trial 
                        information within 30 days of such 
                        notification.
                    ``(E) Penalty for non-compliance.--In determining 
                whether to apply a penalty under section 301(ii) of the 
                Federal Food, Drug, and Cosmetic Act, the Secretary, 
                acting through the Commissioner of Food and Drugs, 
                shall consider--
                            ``(i) whether the responsible party 
                        promptly corrects the non-compliance when 
                        provided notice;
                            ``(ii) whether the responsible party has 
                        engaged in a pattern or practice of non-
                        compliance; and
                            ``(iii) the extent to which the 
                        noncompliance involved may have significantly 
                        misled healthcare providers or patients 
                        concerning the safety or effectiveness of the 
                        drug involved.
            ``(5) Limitation on disclosure of clinical trial 
        information.--Disclosure to the public of clinical trial 
        information submitted to the Director of NIH under this 
        subsection and requested under section 552 of title 5, United 
        States Code (commonly known as the Freedom of Information Act) 
        shall be made only as provided for under paragraphs (2) and 
        (3).
            ``(6) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection such 
        sums as may be necessary.''.
    (b) Conforming Amendments.--
            (1) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(ii)(1) The failure to submit clinical trial information as 
required by section 402(j) of the Public Health Service Act.
    ``(2) The submission of clinical trial information under section 
402(j) of the Public Health Service Act that is promotional or false or 
misleading in any particular under paragraph (2)(E) or (3)(F) of such 
section 402(j).''.
            (2) New drugs.--
                    (A) Investigational new drugs.--Section 505(i) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(i)) is amended--
                            (i) in paragraph (1)--
                                    (I) in subparagraph (C), by 
                                striking ``and'' after the semicolon;
                                    (II) in subparagraph (D), by 
                                striking the period at the end and 
                                inserting ``; and''; and
                                    (III) by adding at the end the 
                                following:
            ``(E) the submission to the Director of NIH of clinical 
        trial information for the clinical investigation at issue 
        required under section 402(j) of the Public Health Service Act 
        for inclusion in the registry database and the results database 
        described in such section.'';
                            (ii) in paragraph (3)(B)--
                                    (I) in clause (i), by striking 
                                ``or'' after the semicolon;
                                    (II) in clause (ii), by striking 
                                the period at the end and inserting ``; 
                                or''; and
                                    (III) by adding at the end the 
                                following:
            ``(iii) clinical trial information for the clinical 
        investigation at issue was not submitted in compliance with 
        section 402(j) of the Public Health Service Act.''; and
                            (iii) in paragraph (4), by adding at the 
                        end the following: ``The Secretary shall update 
                        such regulations to require inclusion in the 
                        informed consent form a statement that clinical 
                        trial information for such clinical 
                        investigation will be submitted for inclusion 
                        in the registry database and results database, 
                        as applicable, described in section 402(j) of 
                        the Public Health Service Act.''.
                    (B) Refusal to approve application.--Section 505(d) 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(d)) is amended--
                            (i) in the first sentence, by inserting 
                        after ``or any particular;'' the following: 
                        ``or (8) the applicant failed to submit the 
                        clinical trial information for any applicable 
                        clinical trial submitted as part of the 
                        application to the Director of the National 
                        Institutes of Health in compliance with section 
                        402(j) of the Public Health Service Act;''; and
                            (ii) in the second sentence, by striking 
                        ``clauses (1) through (6)'' and inserting ``(1) 
                        through (8)''.
    (c) Guidance.--Not later than 180 days after the date of enactment 
of this Act, the Commissioner of Food and Drugs, in consultation with 
the Director of the National Institutes of Health, shall issue guidance 
to clarify which clinical trials are applicable clinical trials (as 
defined in section 402(j)(2) of the Public Health Service Act, as 
amended by this section) (42 U.S.C. 282(j)(2)) and are required to be 
submitted for inclusion in the clinical trial registry database 
described in such section 402(j)(2).
    (d) Preemption.--
            (1) In general.--No State or political subdivision of a 
        State may establish or continue in effect any requirement for 
        the registration of clinical trials or for the inclusion of 
        information relating to the results of clinical trials in a 
        database.
            (2) Rule of construction.--The fact of submission of 
        clinical trial information, if submitted in compliance with 
        section 402(j) of the Public Health Service Act (as amended by 
        this section) (42 U.S.C. 282(j)), that relates to a use of a 
        drug not included in the labeling of the approved drug shall 
        not be construed by the Secretary or in any administrative or 
        judicial proceeding, as evidence of a new intended use of the 
        drug that is different from the intended use of the drug set 
        forth in the official labeling of the drug. The availability of 
        clinical trial information through the databases under 
        paragraphs (2) and (3) of such section 402(j), if submitted in 
        compliance with such section 402(j), shall not be considered as 
        labeling, adulteration, or misbranding of the drug under the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (e) Effective Dates.--
            (1) Establishment of registry database and results 
        database.--Not later than 1 year after the date of enactment of 
        this Act, the Director of NIH shall establish the registry 
        database and the results database of clinical trials of drugs 
        in accordance with section 402(j) of the Public Health Service 
        Act (42 U.S.C. 282(j)) (as amended by subsection (a)).
            (2) Clinical trials initiated prior to operation of 
        registry database.--The responsible party (as defined in such 
        section 402(j)) for an applicable clinical trial under 
        paragraph (2) of such section 402(j) that is initiated after 
        the date of enactment of this Act and before the date such 
        registry database is established under paragraph (1) of this 
        subsection, shall submit required clinical trial information 
        not later than 120 days after the date such registry database 
        is established.
            (3) Clinical trials initiated after operation of registry 
        database.--The responsible party (as defined in such section 
        402(j)) for an applicable clinical trial under paragraph (2) of 
        such section 402(j) that is initiated after the date such 
        registry database is established under paragraph (1) of this 
        subsection shall submit required clinical trial information in 
        accordance with such paragraph (2).
            (4) Trials completed before operation of results 
        database.--
                    (A) In general.--Paragraph (3) of such section 
                402(j) shall take effect 90 days after the date the 
                results database is established under paragraph (1) of 
                this subsection with respect to any applicable clinical 
                trial (as defined in such section 402(j)(3)) that--
                            (i) involves a drug to treat a serious and 
                        life-threatening condition; and
                            (ii) is completed between the date of 
                        enactment of this section and such date of 
                        establishment under paragraph (1) of this 
                        subsection.
                    (B) Other trials.--Except as provided in 
                subparagraph (A), paragraph (3) of such section 402(j) 
                shall take effect 180 days after the date that the 
                results database is established under paragraph (1) of 
                this subsection with respect to any applicable clinical 
                trial (as defined in such section 402(j)(3)) that is 
                completed between the date of enactment of this Act and 
                such date of establishment under paragraph (1).
                    (C) Trials submitted in an application.--Except as 
                provided in subparagraph (A), paragraph (3) of such 
                section 402(j) shall take effect for any clinical trial 
                if--
                            (i) such clinical trial would otherwise be 
                        an applicable clinical trial under paragraph 
                        (3) except for its date of completion; and
                            (ii) data from such clinical trial is 
                        submitted in an application or supplement to an 
                        application under section 505 of the Food, 
                        Drug, and Cosmetic Act or under section 351 of 
                        the Public Health Service Act that--
                                    (I) is submitted 180 days or more 
                                after the date that the results 
                                database is established under paragraph 
                                (1) of this subsection; and
                                    (II) contains data from an 
                                applicable clinical trial.
            (5) Trials completed after establishment of results 
        database.--Paragraph (3) of such section 402(j) shall apply to 
        any applicable clinical trial that is completed after the date 
        that the results database is established under paragraph (1) of 
        this subsection.
            (6) Funding restrictions.--Subparagraph (A) of paragraph 
        (4) of such section 402(j) shall take effect 210 days after the 
        date that the clinical trial registry database and the clinical 
        trial results database are established under paragraph (1) of 
        this subsection.
            (7) Status of clinicaltrials.gov website.--
                    (A) In general.--After receiving public comment and 
                not later than 90 days after the date of enactment of 
                this Act, the Secretary shall publish in the Federal 
                Register a notice determining the more efficient 
                approach to establishing the registry database 
                described in paragraph (2) of such section 402(j) and 
                whether such approach is--
                            (i) that such registry database should 
                        expand and build upon the database described in 
                        section 402(j) of the Public Health Service Act 
                        (as in effect on the day before the date of 
                        enactment of this Act); or
                            (ii) that such registry database should 
                        supplant the database described in such section 
                        402(j) (as in effect on the day before the date 
                        of enactment of this Act).
                    (B) Clinicaltrials.gov supplanted.--If the 
                Secretary determines to apply the approach described 
                under subparagraph (A)(ii), the Secretary shall 
                maintain an archive of the database described in such 
                section 402(j) (as in effect on the day before the date 
                of enactment of this Act) on the Internet website of 
                the National Library of Medicine.

                    TITLE IV--CONFLICTS OF INTEREST

SEC. 401. CONFLICTS OF INTEREST.

    (a) In General.--Subchapter A of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting 
at the end the following:

``SEC. 712. CONFLICTS OF INTEREST.

    ``(a) Definitions.--For purposes of this section:
            ``(1) Involvement.--The term `involvement' means any 
        financial interest in--
                    ``(A) a product that is under consideration by a 
                panel;
                    ``(B) a competing product of such a product;
                    ``(C) the sponsor of such product; or
                    ``(D) the sponsor of such a competing product.
            ``(2) Panel.--The term `panel' means any committee, board, 
        commission, council, conference, panel, task force, or other 
        similar group, or any subcommittee or other subgroup thereof, 
        that is established by statute or by the Secretary to provide 
        advice or recommendations to the Secretary regarding activities 
        of the Food and Drug Administration.
            ``(3) Product.--The term `product' means a food, drug, 
        biological product, device, or electronic product that is 
        regulated by the Food and Drug Administration.
    ``(b) Appointments to Panels.--
            ``(1) Disclosure.--Prior to appointment to a panel, each 
        candidate member of a panel shall disclose to the Secretary all 
        involvements that such candidate may have with the work likely 
        to be undertaken by the panel during the term of the 
        appointment for which the candidate is under consideration.
            ``(2) Evaluation and criteria.--When considering an 
        appointment to a panel, the Secretary--
                    ``(A) shall review the expertise and potential 
                involvements of the candidate for appointment relative 
                to the scope of work likely to be undertaken by the 
                panel during the term of the appointment for which the 
                candidate is under consideration, so as to--
                            ``(i) maximize to the extent practicable 
                        the appointment of qualified individuals with 
                        no involvements, or only potential involvements 
                        of low magnitude, with such work; and
                            ``(ii) minimize to the extent practicable 
                        the appointment of individuals with potential 
                        involvements of high magnitude with such work; 
                        and
                    ``(B) may appoint 2 or more qualified individuals 
                with similar expertise and non-overlapping or minimally 
                overlapping potential involvements, so as to minimize 
                the likelihood that a panel will need the expertise of 
                an appointed individual who requires a waiver for 
                service on the panel at a meeting of such panel.
    ``(c) Disclosure by Panel Member.--
            ``(1) In general.--Prior to a meeting of a panel, each 
        member of such panel shall disclose to the Secretary all 
        involvements that such member may have with the work to be 
        undertaken by such panel at such meeting.
            ``(2) Determination by secretary with respect to panel 
        meetings.--
                    ``(A) In general.--The Secretary shall make a 
                determination with respect to each panel member based 
                on the expertise of such panel member and the 
                disclosure under paragraph (1). Such a determination 
                shall be in one of the following categories:
                            ``(i) Approval for service.--The Secretary 
                        shall make the determination of approval for 
                        service for a panel member if there are no 
                        involvements or if the involvements of the 
                        panel member are of low magnitude.
                            ``(ii) Approval for service with a waiver 
                        or limited waiver.--The Secretary shall make 
                        the determination of approval for service with 
                        a waiver or limited waiver for a panel member 
                        if the involvements of the panel member are of 
                        medium or high magnitude and the Secretary 
                        certifies in writing that--
                                    ``(I) such waiver is necessary to 
                                provide the panel with essential 
                                expertise; or
                                    ``(II) the need for the 
                                individual's service outweighs the 
                                potential for a conflict of interest 
                                created by the disclosed involvements.
                            ``(iii) Recusal.--The Secretary shall make 
                        the determination of recusal for a panel member 
                        if the involvements of the panel member are of 
                        medium or high magnitude but a waiver or 
                        limited waiver could not be granted under 
                        clause (ii) because the criteria for 
                        certification by the Secretary under such 
                        clause were not met.
                    ``(B) Notice of determination.--
                            ``(i) More than 15 days in advance.--A soon 
                        as practicable, but in no case later than 15 
                        days prior to a meeting of a panel to which a 
                        determination for a panel member under clause 
                        (ii) or (iii) of subparagraph (A) applies, the 
                        Secretary shall disclose (other than 
                        information exempted from disclosure under 
                        section 552 of title 5, United States Code 
                        (popularly known as the Freedom of Information 
                        Act)) on the Internet website of the Food and 
                        Drug Administration--
                                    ``(I) the type of the involvements;
                                    ``(II) the nature of the 
                                involvements;
                                    ``(III) the magnitude of the 
                                involvements; and
                                    ``(IV) the reasons for any 
                                determination of the Secretary under 
                                such clause (ii).
                            ``(ii) Less than 15 days in advance.--In 
                        the case of a conflict of interest that becomes 
                        known to the Secretary less than 15 days prior 
                        to a meeting to which the determination under 
                        clause (ii) or (iii) of subparagraph (A) 
                        applies, the Secretary shall disclose (other 
                        than information exempted from disclosure under 
                        section 552 of title 5, United States Code 
                        (popularly known as the Freedom of Information 
                        Act)) on the Internet website of the Food and 
                        Drug Administration, the information described 
                        in subclauses (I) through (IV) of clause (i) of 
                        this subparagraph as soon as practicable, but 
                        in no event later than the date of such 
                        meeting.
    ``(d) Limitations.--In no case--
            ``(1) may the Secretary grant a waiver under subsection 
        (c)(2) for a panel member if the scientific work of such member 
        is under consideration by the panel; or
            ``(2) may a panel member vote with respect to any matter 
        considered by the panel if such panel member or an immediate 
        family member of such panel member could gain financially from 
        the advice given to the Secretary with respect to such matter.
    ``(e) Public Record.--The Secretary shall ensure that the public 
record of each meeting of a panel includes a description of any 
determination of the Secretary made under subsection (c)(2), including 
the category of such determination and the involvements of each panel 
member (other than information exempted from disclosure under section 
552 of title 5, United States Code (popularly known as the Freedom of 
Information Act)).''.
    (b) Guidance.--
            (1) Nominations.--Not later than 270 days after the date of 
        enactment of this Act the Secretary shall publish in the 
        Federal Register for public comment a proposed mechanism for 
        encouraging the nomination of individuals who are classified by 
        the Food and Drug Administration as academicians or 
        practitioners for service on a panel (as defined in section 712 
        of the Federal Food, Drug, and Cosmetic Act (as added by this 
        section)).
            (2) Conflict of interest determinations.--Not later than 
        270 days after the date of enactment of this Act the Secretary 
        shall issue or revise guidance--
                    (A) that defines the circumstances that, taking 
                into consideration the categories of determination 
                under subsection (c) of section 712 of the Federal 
                Food, Drug, and Cosmetic Act (as added by this 
                section)--
                            (i) favor the inclusion of an individual on 
                        a panel;
                            (ii) favor a waiver of a conflict of 
                        interest requirement for an individual on a 
                        panel;
                            (iii) favor a limited waiver of a conflict 
                        of interest requirement for an individual on a 
                        panel; and
                            (iv) disfavor the inclusion of an 
                        individual on a panel;
                    (B) that gives greater priority to consideration of 
                an individual's net worth over consideration of 
                absolute dollar value of an involvement in evaluating 
                the magnitude of an involvement for purposes of making 
                a determination under such subsection (c);
                    (C) that defines how financial interests imputed to 
                an individual bear upon his or her eligibility for 
                service on a panel or for service at a meeting of a 
                panel;
                    (D) that clarifies and improves the processes to 
                ensure disclosure of, and to verify the accuracy of, 
                financial interests imputed to an individual; and
                    (E) to ensure consistency within and among the 
                centers of the Food and Drug Administration in the 
                issuance of determinations under such subsection (c).
            (3) Periodic review.--At least once every 5 years, the 
        Secretary shall review the guidance described under paragraph 
        (2) and update such guidance as necessary.
    (c) Review by Inspector General.--
            (1) In general.--The Inspector General of the Department of 
        Health and Human Services shall, on a periodic basis, conduct a 
        review of the current financial interests, which shall be 
        disclosed to the Inspector General in the same format and 
        manner as under subsection (c) of section 712 of the Federal 
        Food, Drug, and Cosmetic Act (as added by this section), of a 
        representative sample of individuals who have completed service 
        on such a panel (as defined in such section 712).
            (2) Submission of report.--As part of the semiannual report 
        required under section 5 of the Inspector General Act of 1978 
        (5 U.S.C. App.), the Inspector General of the Department of 
        Health and Human Services shall include any findings with 
        respect to an individual being rewarded or otherwise 
        compensated by a sponsor of a product or a sponsor of a 
        competing product in exchange for the individual's vote as a 
        member of a panel of the Food and Drug Administration which 
        considered the product or a competing product (as such terms 
        are used in such section 712), or the absence of any such 
        findings.
    (d) Conforming Amendment.--Section 505(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--
            (1) striking paragraph (4); and
            (2) redesignating paragraphs (5), (6), (7), and (8) as 
        paragraphs (4), (5), (6), and (7), respectively.
    (e) Effective Date.--The amendments made by this section shall take 
effect on October 1, 2007.
                                 <all>