[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1561 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 1561

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 HOUSE OF REPRESENTATIVES

                             March 19, 2007

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

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act and the Federal Food, Drug, and 
   Cosmetic Act 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 2007''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
           TITLE I--RISK EVALUATION AND MITIGATION STRATEGIES

Sec. 101. Risk evaluation and mitigation strategies.
Sec. 102. Enforcement.
Sec. 103. Regulation of biological products.
Sec. 104. No effect on withdrawal or suspension of approval.
Sec. 105. Drugs subject to an abbreviated new drug application.
Sec. 106. Conforming amendments.
Sec. 107. Resources.
Sec. 108. Drug labeling.
Sec. 109. Factory inspections.
Sec. 110. Study on integration of expertise of Office of Surveillance 
                            and Epidemiology.
Sec. 111. Benefit-risk assessments.
Sec. 112. Effective date and applicability.
Sec. 113. Rule of construction regarding pediatric studies.
Sec. 114. Authorization of appropriations.
    TITLE II--REAGAN-UDALL INSTITUTE FOR APPLIED BIOMEDICAL RESEARCH

Sec. 201. The Reagan-Udall Institute for Applied Biomedical Research.
                       TITLE III--CLINICAL TRIALS

Sec. 301. Clinical trial registry database and clinical trial results 
                            database.
                    TITLE IV--CONFLICTS OF INTEREST

Sec. 401. Conflicts of interest.

           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 to 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.
            ``(2) Definitions.--In this subsection:
                    ``(A) Adverse drug experience.--The term `adverse 
                drug experience' means any adverse event associated 
                with the use of a drug in humans, whether or not 
                considered drug related, including--
                            ``(i) an adverse event occurring in the 
                        course of the use of the drug in professional 
                        practice;
                            ``(ii) an adverse event occurring from an 
                        overdose of the drug, whether accidental or 
                        intentional;
                            ``(iii) an adverse event occurring from 
                        abuse of the drug;
                            ``(iv) an adverse event occurring from 
                        withdrawal of the drug; and
                            ``(v) any failure of expected 
                        pharmacological action of the drug.
                    ``(B) Serious adverse drug experience.--The term 
                `serious adverse drug experience' is an adverse event 
                that--
                            ``(i) results in--
                                    ``(I) death;
                                    ``(II) an adverse drug experience 
                                that places the patient at immediate 
                                risk of death from the adverse drug 
                                experience as it occurred (not 
                                including an adverse drug experience 
                                that might have caused death had it 
                                occurred in a more severe form);
                                    ``(III) inpatient hospitalization 
                                or prolongation of existing 
                                hospitalization;
                                    ``(IV) a persistent or significant 
                                incapacity or substantial disruption of 
                                the ability to conduct normal life 
                                functions; or
                                    ``(V) a congenital anomaly or birth 
                                defect; or
                            ``(ii) based on appropriate medical 
                        judgment, may jeopardize the patient and may 
                        require a medical or surgical intervention to 
                        prevent an outcome described under clause (i).
                    ``(C) Serious risk.--The term `serious risk' means 
                a risk of a serious adverse drug experience.
                    ``(D) Unexpected serious risk.--The term 
                `unexpected serious risk' means a serious adverse drug 
                experience 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, specificity, or prevalence.
                    ``(E) Signal of a serious risk.--The term `signal 
                of a serious risk' means information related to a 
                serious adverse drug experience 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.
                    ``(F) 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 obtained since the last assessment of such 
                        strategy.
            ``(3) Required elements of a risk evaluation and mitigation 
        strategy.--The risk evaluation and mitigation strategy for a 
        drug shall require--
                    ``(A)(i) labeling for the drug for use by health 
                care providers as approved under subsection (c); and
                    ``(ii) for the first 2 years (or for such period as 
                the Secretary determines on a case-by-case basis to be 
                appropriate) after the drug or a new indication for the 
                drug is approved, inclusion in the labeling and any 
                direct-to-consumer advertisements of a unique symbol 
                indicating the newly approved status of the drug or 
                indication;
                    ``(B)(i) submission of reports for the drug as 
                required under subsection (k); and
                    ``(ii) for a drug that is a vaccine--
                            ``(I) analysis of reports to the Vaccine 
                        Adverse Event Reporting Systems (VAERS); or
                            ``(II) surveillance using the Vaccine 
                        Safety Datalink (VSD) or successor databases;
                    ``(C) a pharmacovigilance statement--
                            ``(i) as to whether 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; and
                            ``(ii) if such reports, such analysis and 
                        surveillance, and such periodic assessment are 
                        not sufficient to assess the serious risks and 
                        to identify unexpected serious risks of the 
                        drug, that describes what study or studies of 
                        the drug are required under paragraph (4)(D) or 
                        what clinical trial or trials of the drug are 
                        required under paragraph (4)(E);
                    ``(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 or 
                        prevent;
                            ``(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 safety of 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;
                            ``(ii) shall include an assessment in the 
                        seventh year after the drug is so approved; and
                            ``(iii) subject to clause (ii), for 
                        subsequent years--
                                    ``(I) shall be at a frequency 
                                specified in the strategy;
                                    ``(II) may be increased or reduced 
                                in frequency as necessary as provided 
                                for in paragraph (6)(B)(iv)(VI); and
                                    ``(III) may be eliminated after the 
                                3-year period described in clause (i) 
                                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 Secretary may require that 
                the risk evaluation and mitigation strategy for a drug 
                include 1 or more of the additional elements described 
                in this paragraph, so long as the Secretary makes the 
                determination required with respect to each additional 
                included element.
                    ``(B) Medguide; patient package insert.--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 
                        mitigate 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. Such plan may include--
                            ``(i) sending letters to health care 
                        providers;
                            ``(ii) disseminating information about the 
                        elements of the risk evaluation and mitigation 
                        strategy to encourage implementation by health 
                        care providers of 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 any 
                        protocol to assure safe use.
                    ``(D) Post-approval studies.--The risk evaluation 
                and mitigation strategy for a drug may require that the 
                applicant conduct, or provide that the Secretary will 
                conduct, an appropriate post-approval study, such as a 
                prospective or retrospective observational study 
                (including through the systematic use of established 
                health care networks and databases), of the drug (with 
                a target schedule for completing the study and 
                reporting the results to the Secretary), if the 
                Secretary determines the reports, analysis and 
                surveillance, and periodic assessments referred to in 
                paragraph (3)(C) are not sufficient to--
                            ``(i) assess evidence of a serious risk 
                        related to the safety or effectiveness of the 
                        drug; or
                            ``(ii) identify unexpected serious risks in 
                        domestic populations who use the drug, 
                        including populations not included in studies 
                        used to approve the drug (such as older people, 
                        people with comorbidities, pregnant women, or 
                        children).
                    ``(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) of this section as of the date that the requirement 
                is first imposed conduct an appropriate post-approval 
                clinical trial of the drug (with a target schedule for 
                completing the clinical trial and reporting the results 
                to the Secretary) to be included in the clinical trial 
                registry database and clinical trial results database 
                provided for under section 402(i) of the Public Health 
                Service Act, if the Secretary determines that a study 
                or studies under subparagraph (D) will likely be 
                inadequate to assess evidence of a serious risk related 
                to the safety or effectiveness of the drug.
                    ``(F) Preclearance.--
                            ``(i) In general.--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. The advertisements 
                        required to be submitted under the preceding 
                        sentence shall be reviewed and cleared by the 
                        Secretary within 45 days of submission.
                            ``(ii) Specification of advertisements.--
                        The Secretary may specify the advertisements 
                        required to be submitted under clause (i).
                    ``(G) Specific disclosures.--
                            ``(i) In general.--The risk evaluation and 
                        mitigation strategy for a drug may require that 
                        the applicant include in advertisements of the 
                        drug a specific disclosure--
                                    ``(I) of the date the drug was 
                                approved and that the existing 
                                information may not have identified or 
                                allowed for full assessment of all 
                                serious risks of using the drug, if the 
                                Secretary determines that such 
                                disclosure is necessary to protect 
                                public health and safety; or
                                    ``(II) about a serious adverse 
                                event listed in the labeling of the 
                                drug or a protocol to ensure safe use 
                                described in the labeling of the drug, 
                                if the Secretary determines that such 
                                advertisements lacking such disclosure 
                                would be false or misleading.
                            ``(ii) Specification of advertisements.--
                        The Secretary may specify the advertisements 
                        required to include a specific disclosure under 
                        clause (i).
                    ``(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 3 
                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 clinical trials 
                        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 or use.--
                    ``(A) In general.--If the Secretary determines that 
                a drug shown to be effective can be safely used only if 
                distribution or use of such drug is restricted, the 
                Secretary may require as elements of the risk 
                evaluation and mitigation strategy such restrictions on 
                distribution or use as are needed to ensure safe use of 
                the drug.
                    ``(B) Limits on restrictions.--Such restrictions 
                under subparagraph (A) shall--
                            ``(i) be commensurate with the specific 
                        risk presented by the drug;
                            ``(ii) not be unduly burdensome on patient 
                        access to the drug, particularly for patients 
                        with serious or life-threatening diseases or 
                        conditions; and
                            ``(iii) to the extent practicable, conform 
                        with restrictions on distribution or use for 
                        other drugs with similar risks, so as to 
                        minimize the burden on the health care delivery 
                        system.
                    ``(C) Elements.--The restrictions on distribution 
                or use described in subparagraph (A) shall include 1 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 special training or experience, 
                        or are specially certified;
                            ``(ii) pharmacies, practitioners, or health 
                        care settings that dispense the drug are 
                        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) Implementation system.--The restrictions on 
                distribution or use described in subparagraph (A) may 
                require a system through which the applicant is able 
                to--
                            ``(i) monitor and evaluate 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;
                            ``(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) stop distribution of the drug to 
                        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.
                    ``(E) Patents.--The Secretary shall not approve a 
                risk evaluation and mitigation strategy for a drug, or 
                any modification to the strategy, under paragraph (6) 
                if--
                            ``(i) the strategy includes a restriction 
                        on distribution or use described in 
                        subparagraph (A) that is protected by a patent;
                            ``(ii) such patent was issued after the 
                        date of the enactment of this subsection; and
                            ``(iii) such patent would prohibit or 
                        impair the application of such restriction 
                        under section 505(j)(2)(E)(i)(VII) to a drug 
                        that is the subject of an abbreviated new drug 
                        application.
            ``(6) Submission and review of risk evaluation and 
        mitigation strategy.--
                    ``(A) Proposed risk evaluation and mitigation 
                strategy.--
                            ``(i) Initial approval.--An applicant shall 
                        include a proposed risk evaluation and 
                        mitigation strategy in an application under 
                        subsection (b) or section 351 of the Public 
                        Health Service Act for initial approval of the 
                        drug.
                            ``(ii) Approval of new indication.--If no 
                        risk evaluation and mitigation strategy for the 
                        drug is in effect under this subsection and the 
                        drug may not be dispensed without a 
                        prescription, the applicant shall include a 
                        proposed risk evaluation and mitigation 
                        strategy in an application, including in a 
                        supplemental application, seeking a new 
                        indication for such drug.
                            ``(iii) Contents.--A proposed risk 
                        evaluation and mitigation strategy--
                                    ``(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) Voluntary assessments.--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.
                            ``(ii) Required assessments.--The applicant 
                        shall submit an assessment of, and may propose 
                        a modification to, the approved risk evaluation 
                        and mitigation strategy for a drug--
                                    ``(I) when submitting a 
                                supplemental application for a new 
                                indication under subsection (b) or 
                                section 351 of the Public Health 
                                Service Act, unless the drug may be 
                                dispensed without a prescription and 
                                the risk evaluation and mitigation 
                                strategy for the drug includes only the 
                                elements under paragraph (3);
                                    ``(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 or effectiveness 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 or 
                                effectiveness 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).
                            ``(iii) Assessment.--An assessment 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 
                                how well the restrictions on 
                                distribution or 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, 
                                including whether any difficulties 
                                completing the study have been 
                                encountered; and
                                    ``(III) with respect to any post-
                                approval clinical trial required under 
                                paragraph (4)(E), the status of such 
                                clinical trial, including whether 
                                enrollment has begun, the number of 
                                participants enrolled, the expected 
                                completion date, whether any 
                                difficulties completing the clinical 
                                trial have been encountered, and 
                                registration information with respect 
                                to requirements under section 402(i) of 
                                the Public Health Service Act.
                            ``(iv) 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), and (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), including to 
                                eliminate assessments.
                    ``(C) Review.--
                            ``(i) In general.--The Secretary shall 
                        promptly review the proposed risk evaluation 
                        and mitigation strategy for a drug submitted 
                        under subparagraph (A), or an assessment of the 
                        approved risk evaluation and mitigation 
                        strategy for a drug submitted under 
                        subparagraph (B).
                            ``(ii) Marketing plan.--As part of a review 
                        conducted under this subparagraph, the 
                        Secretary may require the applicant to submit 
                        its marketing plan for the drug, so as to allow 
                        the Secretary to determine whether any of the 
                        proposed or ongoing marketing activities 
                        undermine any of the requirements of the risk 
                        evaluation and mitigation strategy.
                    ``(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 strategy--
                            ``(i) if the proposed strategy or 
                        assessment is submitted as part of an 
                        application or supplemental application under 
                        subparagraph (A) or (B)(ii)(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) if the assessment is submitted under 
                        subclause (II) or (III) of subparagraph 
                        (B)(ii), not later than 20 days after such 
                        submission;
                            ``(iii) if the assessment is submitted 
                        under subparagraph (B)(i) or under subparagraph 
                        (B)(ii)(IV), not later than 30 days after such 
                        submission; or
                            ``(iv) if the assessment is submitted under 
                        subparagraph (B)(ii)(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)(ii)(I); or
                                    ``(II) in an order issued not later 
                                than 50 days after the date discussions 
                                of such modification begin under 
                                subparagraph (C), when an assessment of 
                                the strategy is under subparagraph 
                                (B)(i) or under subclause (II), (III), 
                                (IV), or (V) of subparagraph (B)(ii).
                            ``(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).
                            ``(iii) Public availability.--Any action 
                        letter described in clause (i)(I) or order 
                        described in clause (i)(II) shall be made 
                        publicly available.
                    ``(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, 
                        the applicant may request in writing that a 
                        dispute about the strategy be reviewed by the 
                        Drug Safety Oversight Board. Upon receipt of 
                        such a request, the Secretary shall schedule 
                        the dispute for review under clause (ii) and, 
                        not later than 5 business days of scheduling 
                        the dispute for review, shall publish by 
                        posting on the Internet or otherwise a notice 
                        that the dispute will 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 after discussion or 
                        administrative appeals.--
                                    ``(I) Further discussion or 
                                administrative appeals.--A request for 
                                review under clause (i) shall not 
                                preclude further discussions to reach 
                                agreement on the risk evaluation and 
                                mitigation strategy, and such a request 
                                shall not preclude the use of 
                                administrative appeals within the Food 
                                and Drug Administration to reach 
                                agreement on the strategy, including 
                                appeals 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) for 
                                procedural or scientific matters 
                                involving the review of human drug 
                                applications and supplemental 
                                applications that cannot be resolved at 
                                the divisional level.
                                    ``(II) Agreement terminates dispute 
                                resolution.--At any time before a 
                                decision and order is issued under 
                                clause (vii), the Secretary and the 
                                applicant may reach an agreement on the 
                                risk evaluation and mitigation strategy 
                                through further discussion or 
                                administrative appeals, terminating the 
                                dispute resolution process, and the 
                                Secretary shall issue an action letter 
                                or order, as appropriate, that 
                                describes the 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) Record of proceedings.--The Secretary 
                        shall ensure that the proceedings of any such 
                        meeting are recorded, transcribed, and made 
                        public within 30 days of the meeting. The 
                        Secretary shall redact the transcript to 
                        protect any trade secrets or other confidential 
                        information described in section 552(b)(4) of 
                        title 5, United States Code.
                            ``(vi) Recommendation of the board.--Not 
                        later than 5 days after any such meeting, the 
                        Drug Safety Oversight Board shall provide a 
                        written recommendation on resolving the dispute 
                        to the Secretary. Not later than 5 days after 
                        the Board provides such written recommendation 
                        to the Secretary, the Secretary shall make the 
                        recommendation available to the public.
                            ``(vii) 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)(ii)(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 under subparagraph 
                                (B)(i) or under subclause (II), (III), 
                                (IV), or (V) of subparagraph (B)(ii), 
                                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.
                            ``(viii) 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 (vii).
                            ``(ix) 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)(ii)(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 subparagraph (D) not 
                                less than 60 days before such action 
                                deadline; and
                                    ``(II) has complied with the timing 
                                requirements of scheduling review by 
                                the Drug Safety Oversight Board, 
                                providing a written recommendation, and 
                                issuing an action letter under clauses 
                                (ii), (vi), and (vii), respectively.
                            ``(x) Disqualification.--No individual who 
                        is an employee of the Food and Drug 
                        Administration and who reviews a drug or who 
                        participated in an administrative appeal under 
                        clause (iii)(I) 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 with 
                        relevant expertise from the Food and Drug 
                        Administration, including the Office of 
                        Pediatrics, the Office of Women's Health, or 
                        the Office of Rare Diseases, or from other 
                        Federal public health or health care agencies, 
                        for a meeting under clause (iv) of the Drug 
                        Safety Oversight Board.
                    ``(G) Use of advisory committees.--The Secretary 
                may convene a meeting of 1 or more advisory committees 
                of the Food and Drug Administration to--
                            ``(i) review a concern about the safety of 
                        a drug or class of drugs, including before an 
                        assessment of the risk evaluation and 
                        mitigation strategy or strategies of such drug 
                        or drugs is required to be submitted under 
                        subclause (II), (III), (IV), or (V) of 
                        subparagraph (B)(ii);
                            ``(ii) review the risk evaluation and 
                        mitigation strategy or strategies of a drug or 
                        group of drugs; or
                            ``(iii) review a dispute under subparagraph 
                        (F).
                    ``(H) 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 1 
                        or more public meetings to consider possible 
                        responses to such concern. If the Secretary 
                        defers an assessment under this clause, the 
                        Secretary shall give notice to the public of 
                        the deferral not later than 5 days of the 
                        deferral.
                            ``(ii) Public meetings.--Such public 
                        meetings may include--
                                    ``(I) 1 or more meetings of the 
                                applicants for such drugs;
                                    ``(II) 1 or more meetings of 1 or 
                                more advisory committees of the Food 
                                and Drug Administration, as provided 
                                for under subparagraph (G); or
                                    ``(III) 1 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.
                    ``(I) International coordination.--The Secretary 
                may coordinate 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 identify and assess 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. If the Secretary takes action to coordinate 
                such timetable, the Secretary shall give notice to the 
                public of the action not later than 5 days after the 
                action.
                    ``(J) Effect.--Use of the processes described in 
                subparagraphs (H) and (I) shall not delay action on an 
                application or a supplement to an application for a 
                drug.
                    ``(K) 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.
            ``(7) Drug safety oversight board.--
                    ``(A) In general.--There is established a Drug 
                Safety Oversight Board.
                    ``(B) Composition; meetings.--The Drug Safety 
                Oversight Board shall--
                            ``(i) be composed of scientists and health 
                        care practitioners appointed by the Secretary, 
                        each of whom is an employee of the Federal 
                        Government;
                            ``(ii) include representatives from offices 
                        throughout the Food and Drug Administration;
                            ``(iii) include at least 1 representative 
                        from each of the National Institutes of Health, 
                        the Department of Health and Human Services 
                        (other than the Food and Drug Administration), 
                        and the Veterans Health Administration; and
                            ``(iv) meet at least monthly to provide 
                        oversight and advice to the Secretary on the 
                        management of important drug safety issues.''.

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:
    ``(y) 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 provided 
        for under paragraph (3), (4), or (5) of such section.
    ``(z) Failure to conduct a postmarket study required under section 
506 (or any regulation thereunder).''.
    (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) Any person who violates a requirement of this Act which 
relates to drugs shall be liable to the United States for a civil 
penalty in an amount not less than $50,000 for each such violation and, 
for all such violations adjudicated in a single proceeding, in an 
amount not to exceed the following:
    ``(A) For drugs on the market for at least one year, 10 percent of 
the annual United States sales revenue during the year prior to which 
the person is subject to the civil penalty, based upon data from IMS 
Health Inc.'s Retail and Provider Prospective Combined Purchases on the 
United States sales revenue of the drug or, in the event IMS data is 
not available, based upon any comparable data.
    ``(B) For drugs on the market for less than one year, 
$1,000,000.'';
            (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. 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''.

SEC. 104. NO EFFECT ON 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 
this section, 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)(ii)(V).''.

SEC. 105. 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:
    ``(E) Risk Evaluation and Mitigation Strategy Requirement.--
            ``(i) In general.--A drug that is the subject of an 
        abbreviated new drug application under this subsection shall be 
        subject to only the following elements of the risk evaluation 
        and mitigation strategy required under subsection (o) for the 
        applicable listed drug:
                    ``(I) Labeling, as required under subsection 
                (o)(3)(A) for the applicable listed drug.
                    ``(II) Submission of reports, as required under 
                subsection (o)(3)(B)(i) for the applicable listed drug.
                    ``(III) A Medication Guide or patient package 
                insert, if required under subsection (o)(4)(B) for the 
                applicable listed drug.
                    ``(IV) Preclearance of advertising, if required 
                under subsection (o)(4)(F) for the applicable listed 
                drug.
                    ``(V) Specific disclosures in advertising, if 
                required under subsection (o)(4)(G) for the applicable 
                listed drug.
                    ``(VI) A temporary moratorium on direct-to-consumer 
                advertising, if required under subsection (o)(4)(H) for 
                the applicable listed drug.
                    ``(VII) Restrictions on distribution or use, if 
                required under subsection (o)(5) for the listed drug. A 
                drug that is the subject of an abbreviated new drug 
                application and the listed drug shall use a single, 
                shared system under subsection (o)(5)(D). The Secretary 
                may waive the requirement under the preceding sentence 
                for a drug that is the subject of an abbreviated new 
                drug application if the Secretary determines that (aa) 
                it is not practical for the drug to use such single, 
                shared system or (bb) the burden of using the single, 
                shared system outweighs the benefit of using the single 
                system.
            ``(ii) Action by secretary.--For an applicable listed drug 
        for which a drug is approved under this subsection, the 
        Secretary--
                    ``(I) shall undertake any communication plan to 
                health care providers required under section (o)(4)(C) 
                for the applicable listed drug;
                    ``(II) shall conduct any post-approval study 
                required under subsection (o)(4)(D) for the applicable 
                listed drug; and
                    ``(III) shall inform the applicant for a drug 
                approved under this subsection if the risk evaluation 
                and mitigation strategy for the applicable listed drug 
                is modified.''.

SEC. 106. CONFORMING AMENDMENTS.

    (a) Preclearance of Advertisements.--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''.
    (b) Content of 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).''.

SEC. 107. 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 or effectiveness information on 
                drugs, including adverse event reports.''.
    (b) Workload Adjustment.--Subparagraph (A) of section 736(c)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(2)) is 
amended to read as follows:
                    ``(A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total number of human drug applications; commercial 
                investigational new drug applications; efficacy 
                supplements; manufacturing supplements; implementation, 
                assessment, review, and enforcement activities for risk 
                evaluation and mitigation strategies; and uses of 
                dispute resolution under the process for reviewing and 
                assessing risk evaluation and mitigation strategies. 
                The Secretary shall publish in the Federal Register the 
                fee revenues and fees resulting from the adjustment and 
                supporting methodologies.''.
    (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 systems for data collection, access 
        to data in external health care databases (including databases 
        of the Centers for Medicare & Medicaid Services and the 
        Department of Veterans Affairs), data mining capabilities, 
        personnel, and personnel training programs, needed by the Food 
        and Drug Administration to--
                    (A) comply with the requirements of this title (and 
                the amendments made by this title);
                    (B) achieve interoperability within and among the 
                Centers of the Food and Drug Administration and between 
                the Food and Drug Administration and product 
                application sponsors; and
                    (C) utilize 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 assessments 
        under paragraph (1);
            (3) a plan for enhancing the information technology assets 
        of the Food and Drug Administration toward meeting the needs 
        assessments 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. 108. 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 health warnings, Dear Doctor 
letters, and 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 Health, Education, Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representatives 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 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. 109. FACTORY INSPECTIONS.

    Paragraph (1) of section 704(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(a)) is amended by inserting ``or marketing 
data'' after ``No inspection authorized by the preceding sentence or by 
paragraph (3) shall extend to financial data, sales data other than 
shipment data''.

SEC. 110. STUDY ON INTEGRATION OF EXPERTISE OF OFFICE OF SURVEILLANCE 
              AND EPIDEMIOLOGY.

    Not later than 1 year after the date of the enactment of this Act, 
the Commissioner of Food and Drugs shall submit a report to the 
Congress on the Commissioner's efforts to integrate the expertise of 
the Office of Surveillance and Epidemiology into the Food and Drug 
Administration's approval, labeling, and post-approval safety 
decisions.

SEC. 111. BENEFIT-RISK ASSESSMENTS.

    Not later than 1 year after the date of the enactment of this Act, 
the Commissioner of Food and Drugs shall submit to the Congress a 
report on how best to communicate to the public the risks and benefits 
of new drugs and the role of the risk evaluation and mitigation 
strategy in assessing such risks and benefits.

SEC. 112. 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 shall be deemed to have an 
        approved risk evaluation and mitigation strategy under section 
        505(o) of the Federal Food, Drug, and Cosmetic Act (as added by 
        this title) if there are in effect on the effective date of 
        this title restrictions on distribution or use--
                    (A) required under section 314.520 or section 
                601.42 of title 21, Code of Federal Regulations; or
                    (B) otherwise agreed to by the applicant and the 
                Secretary for such drug.
            (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).
    (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)(ii) of such section 
505(o) if the Secretary determines (with respect to such drug or with 
respect to the group of drugs to which such drug belongs) 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 or class of drugs may apply.
    (d) Use of Advisory Committees; Process for Addressing Drug Class 
Effects.--In imposing a requirement under subsection (c), the 
Secretary--
            (1) may convene a meeting of 1 or more advisory committees 
        of the Food and Drug Administration in accordance with 
        paragraph (6)(G) of such section 505(o); and
            (2) may use the process described in paragraph (6)(H) of 
        such section 505(o) (relating to addressing drug class 
        effects).

SEC. 113. RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.

    Nothing in this Act or the amendments made by this Act shall be 
construed to affect the authority of the Secretary or the Commissioner 
of Food and Drugs to require pediatric studies under section 505A of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a).

SEC. 114. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For carrying out this title and the amendments 
made by this title, there is authorized to be appropriated $25,000,000 
for each of fiscal years 2008 through 2012.
    (b) Relation to Other Funding.--The authorization of appropriations 
under subsection (a) is in addition to any other funds available for 
carrying out this title and the amendments made by this title.

    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.), as amended by Public Law 109-462, 
is amended by adding at the end the following:

 ``Subchapter I--Reagan-Udall Institute for Applied Biomedical Research

``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE INSTITUTE.

    ``(a) In General.--The Secretary shall establish a nonprofit 
corporation 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). The Institute shall not be an agency or instrumentality of the 
United States Government.
    ``(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.
    ``(c) Duties of the Institute.--The Institute shall--
            ``(1) taking into consideration the 2004 report published 
        by the Food and Drug Administration entitled `Innovation or 
        Stagnation? Challenge and Opportunity on the Critical Path to 
        New Medical Products', identify unmet needs in the sciences of 
        developing, manufacturing, and evaluating the safety and 
        effectiveness of diagnostics, devices, biologics, and drugs, 
        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 and medical product safety;
                    ``(C) pharmacogenomics and inter-individual 
                variability in drug, biologic, and device response;
                    ``(D) the development of data analysis technology 
                and methodology for use in device, biologic, drug, and 
                diagnostic development;
                    ``(E) advancing improvements to the design and 
                conduct of clinical trials;
                    ``(F) toxicological quality assessment 
                technologies;
                    ``(G) diagnostic, device, biologic, and drug 
                manufacturing, design, and materials science;
                    ``(H) failure mode assessment for medical product 
                development;
                    ``(I) improving adverse event reporting and 
                analysis;
                    ``(J) bridging engineering data and clinical 
                performance for devices; and
                    ``(K) computer modeling;
            ``(2) establish goals and priorities in order to meet the 
        unmet needs identified in paragraph (1);
            ``(3) in consultation with the Secretary, assess existing 
        and proposed Federal intramural and extramural research and 
        development programs relating to the goals and priorities 
        established under paragraph (2) and facilitate and encourage 
        interagency coordination of such programs;
            ``(4) award grants to, or enter into contracts or 
        cooperative agreements with, scientists and entities to advance 
        the goals and priorities established under paragraph (2);
            ``(5) recruit meeting participants and hold or sponsor (in 
        whole or in part) meetings as appropriate to further the goals 
        and priorities established under paragraph (2);
            ``(6) 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 to 
        further the goals and priorities established under paragraph 
        (2);
            ``(7) 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 to further the 
                goals and priorities established under paragraph (2);
            ``(8) provide objective clinical and scientific information 
        to the Food and Drug Administration and, upon request, to other 
        Federal agencies to assist in agency determinations of how to 
        ensure that regulatory policy accommodates scientific advances;
            ``(9) conduct annual assessments of the unmet needs 
        identified in paragraph (1); 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 the Board 
                        of Directors of the Institute;
                            ``(ii) the Commissioner of Food and Drugs;
                            ``(iii) the Director of the National 
                        Institutes of Health;
                            ``(iv) the Director of the Centers for 
                        Disease Control and Prevention; and
                            ``(v) the Director of the Agency for 
                        Healthcare Research and Quality.
                    ``(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) 3 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) 3 shall be representatives 
                                of patient advocacy and consumer 
                                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 areas including 
                        clinical pharmacology, biomedical informatics, 
                        product safety, process improvement and 
                        pharmaceutical sciences, and medical device and 
                        biomedical engineering.
                    ``(D) Initial meeting.--
                            ``(i) In general.--Not later than 30 days 
                        after the date of the enactment of the 
                        Enhancing Drug Safety and Innovation Act of 
                        2007, the Secretary shall convene a meeting of 
                        the ex officio members of the Board to--
                                    ``(I) incorporate the Institute; 
                                and
                                    ``(II) appoint the members of the 
                                Board in accordance with subparagraph 
                                (C).
                            ``(ii) Service of ex officio members.--Upon 
                        the appointment of the members of the Board 
                        under clause (i)(II), the terms of service of 
                        the ex officio members of the Board as members 
                        of the Board shall terminate.
                            ``(iii) Chair.--The ex officio members of 
                        the Board under subparagraph (B) shall 
                        designate an appointed member of the Board to 
                        serve as the Chair of the Board.
            ``(2) Duties of board.--The Board shall--
                    ``(A) establish bylaws for the Institute that--
                            ``(i) are published in the Federal Register 
                        and available for public comment;
                            ``(ii) establish policies for the selection 
                        of the officers, employees, agents, and 
                        contractors of the Institute;
                            ``(iii) establish policies, including 
                        ethical standards, for the acceptance, 
                        solicitation, and disposition of donations and 
                        grants to the Institution and for the 
                        disposition of the assets of the Institute;
                            ``(iv) establish policies whereby any 
                        individual who is an officer, employee, or 
                        member of the Board of the Institute may not 
                        personally or substantially participate in the 
                        consideration or determination by the Institute 
                        of any matter that would directly or 
                        predictably affect any financial interest of 
                        the individual or a relative (as such term is 
                        defined in section 109(16) of the Ethics in 
                        Government Act of 1978) of the individual, of 
                        any business organization or other entity, or 
                        of which the individual is an officer or 
                        employee or is negotiating for employment, or 
                        in which the individual has any other financial 
                        interest;
                            ``(v) 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 (6) and (7) 
                        of subsection (c);
                            ``(vi) specify principles for the review of 
                        proposals and awarding of grants and contracts 
                        that include peer review and that are 
                        substantially consistent with those of the 
                        Foundation for the National Institutes of 
                        Health;
                            ``(vii) specify a process for annual Board 
                        review of the operations of the Institute; and
                            ``(viii) establish specific duties of the 
                        Executive Director;
                    ``(B) prioritize and provide overall direction to 
                the activities of the Institute;
                    ``(C) evaluate the performance of the Executive 
                Director; and
                    ``(D) carry out any other necessary activities 
                regarding the functioning of the Institute.
            ``(3) Additional board functions.--The Board may coordinate 
        and collaborate with other entities to conduct research, 
        education, and outreach, and to modernize the sciences of 
        developing, manufacturing, and evaluating the safety and 
        effectiveness of diagnostics, devices, biologics, and drugs.
            ``(4) 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 individuals described in clauses (i) 
                        through (v) of paragraph (1)(B) by majority 
                        vote.
                    ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed under subparagraph (B) 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.
            ``(5) 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) Incorporation.--The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions necessary to 
incorporate the Institute.
    ``(f) Nonprofit Status.--The Institute shall be considered to be a 
corporation under section 501(c) of the Internal Revenue Code of 1986, 
and shall be subject to the provisions of such section.
    ``(g) 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.
    ``(h) Administrative Powers.--In carrying out this subchapter, the 
Board, acting through the Executive Director, may--
            ``(1) adopt, alter, and use a corporate seal, which shall 
        be judicially noticed;
            ``(2) hire, promote, compensate, and discharge 1 or more 
        officers, employees, and agents, as may be necessary, and 
        define their duties;
            ``(3) 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;
            ``(4) 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;
            ``(5) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            ``(6) hold, administer, invest, and spend any gift, devise, 
        or bequest of real or personal property made to the Institute 
        under subsection (i);
            ``(7) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Board considers 
        appropriate to conduct the activities of the Institute;
            ``(8) modify or consent to the modification of any contract 
        or agreement to which it is a party or in which it has an 
        interest under this subchapter;
            ``(9) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures developed by 
        the Institute and its employees;
            ``(10) sue and be sued in its corporate name, and complain 
        and defend in courts of competent jurisdiction;
            ``(11) appoint other groups of advisors as may be 
        determined necessary to carry out the functions of the 
        Institute; and
            ``(12) 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.
    ``(i) Acceptance of Funds From Other Sources.--The Executive 
Director may solicit and accept on behalf of the Institute, any funds, 
gifts, grants, devises, or bequests of real or personal property made 
to the Institute, including from private entities, for the purposes of 
carrying out the duties of the Institute.
    ``(j) Service of Federal Employees.--Federal Government employees 
may serve on committees advisory to the Institute and otherwise 
cooperate with and assist the Institute in carrying out its functions, 
so long as such employees do not direct or control Institute 
activities.
    ``(k) Detail of Government Employees.--Federal Government employees 
may be detailed from Federal agencies with or without reimbursement to 
those agencies to the Institute at any time, and such detail shall be 
without interruption or loss of civil service status or privilege. Each 
such employee shall abide by the statutory, regulatory, ethical, and 
procedural standards applicable to the employees of the agency from 
which such employee is detailed and those of the Institute.
    ``(l) 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 fda.--Beginning with fiscal year 2009, the 
        Executive Director shall submit to the Commissioner an annual 
        report that--
                    ``(A) details the progress of the Institute in 
                furthering the goals and priorities established under 
                subsection (c)(2); and
                    ``(B) provides recommendations for incorporating 
                such progress into regulatory and product review 
                activities of the Food and Drug Administration.
            ``(3) Report to congress.--Beginning with fiscal year 2009, 
        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;
                    ``(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.
    ``(m) Separation of Funds.--The Executive Director shall ensure 
that the funds received from the Treasury are held in separate accounts 
from funds received from entities under subsection (i).
    ``(n) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each of fiscal years 
2008 through 2013 to carry out subsections (a), (b), and (d) through 
(m).''.
    (b) Other Institute Provisions.--Chapter VII (21 U.S.C. 371 et 
seq.) (as amended by subsection (a)) is amended by adding at the end 
the following:

``SEC. 771. 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.

``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

    ``(a) In General.--The Commissioner shall receive and assess the 
report submitted to the Commissioner by the Executive Director of the 
Institute under section 770(l)(2).
    ``(b) Report to Congress.--The Commissioner 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 describes the implementation of 
any recommendations included in the report described under subsection 
(a).''.

                       TITLE III--CLINICAL TRIALS

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

    (a) In General.--Subsection (i) of section 402 of the Public Health 
Service Act (42 U.S.C. 282), as amended by Public Law 109-482, is 
amended to read as follows:
    ``(i) Clinical Trial Registry Database; Clinical Trial Results 
Database.--
            ``(1) Definitions.--In this subsection:
                    ``(A) Applicable clinical trial.--The term 
                `applicable clinical trial'--
                            ``(i) means a clinical trial that is 
                        conducted to test the safety or effectiveness 
                        (including comparative effectiveness) of a drug 
                        or device (irrespective of whether the clinical 
                        trial is federally or privately funded, and 
                        whether the clinical trial involves an approved 
                        or unapproved drug or device);
                            ``(ii) includes such a clinical trial that 
                        is conducted outside of the United States if--
                                    ``(I) there is an application or 
                                premarket notification pending before 
                                the Food and Drug Administration for 
                                approval or clearance of the drug or 
                                device involved under section 505, 
                                510(k), or 515 of the Federal Food, 
                                Drug, and Cosmetic Act or section 351 
                                of this Act; or
                                    ``(II) the drug or device involved 
                                is so approved or cleared; and
                            ``(iii) notwithstanding subclauses (I) and 
                        (II), excludes--
                                    ``(I) a clinical trial to determine 
                                the safety of a use of a drug that is 
                                designed solely to detect major 
                                toxicities in the drug or to 
                                investigate pharmacokinetics, unless 
                                the clinical trial is designed to 
                                investigate pharmacokinetics in a 
                                special population or populations; and
                                    ``(II) a small clinical trial to 
                                determine the feasibility of a device, 
                                or a clinical trial to test prototype 
                                devices where the primary focus is 
                                feasibility.
                    ``(B) 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.
                    ``(C) Completion date.--The term `completion date' 
                means the date of the final collection of data from 
                subjects in the clinical trial for the primary and 
                secondary outcomes to be examined in the trial.
                    ``(D) Device.--The term `device' has the meaning 
                given to that term in section 201(h) of the Federal 
                Food, Drug, and Cosmetic Act.
                    ``(E) 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.
                    ``(F) Responsible party.--The term `responsible 
                party', with respect to an applicable clinical trial, 
                means--
                            ``(i) the primary sponsor (as defined in 
                        the International Clinical Trials Registry 
                        Platform trial registration data set of the 
                        World Health Organization) of the clinical 
                        trial; or
                            ``(ii) the principal investigator of such 
                        clinical trial if so designated by such 
                        sponsor, so long as the principal investigator 
                        is responsible for conducting the trial, has 
                        access to and control over the data, has the 
                        right to publish the results of the trial, and 
                        has the responsibility to meet all of the 
                        requirements under this section that are 
                        applicable to responsible parties.
            ``(2) Clinical trials registry database.--
                    ``(A) Establishment.--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.
                    ``(B) 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) includes the city, State, and zip 
                        code for each clinical trial location;
                            ``(iii) includes a statement of the 
                        estimated completion date for the clinical 
                        trial;
                            ``(iv) includes the identity and contact 
                        information of the responsible party;
                            ``(v) 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, or the device is not cleared under 
                        section 510(k) or approved under section 515 of 
                        the Federal Food, Drug, and Cosmetic Act, 
                        specifies whether or not there is expanded 
                        access to the drug or device under section 561 
                        of the Federal Food, Drug, and Cosmetic Act for 
                        those who do not qualify for enrollment in the 
                        clinical trial and how to obtain information 
                        about such access;
                            ``(vi) includes, with respect to any 
                        individual who is not an employee of the 
                        responsible party for the clinical trial or of 
                        the manufacturer of the drug or device 
                        involved, information on any agreement that the 
                        responsible party or manufacturer has entered 
                        into with such individual that restricts in any 
                        manner the ability of the individual--
                                    ``(I) to discuss the results of the 
                                trial at a scientific meeting or any 
                                other public or private forum; or
                                    ``(II) to publish the results of 
                                the trial, or a description or 
                                discussion of the results of the trial, 
                                in a scientific or academic journal; 
                                and
                            ``(vii) 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 1 or 
                        more of the following criteria:
                                    ``(I) The indication being studied 
                                in the clinical trial, using Medical 
                                Subject Headers (MeSH) descriptors.
                                    ``(II) The safety issue being 
                                studied in the clinical trial.
                                    ``(III) The enrollment status of 
                                the clinical trial.
                                    ``(IV) 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).
                    ``(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 to include information from any 
                        source other than the clinical trial involved.
                    ``(F) Timing of submission.--Except as provided in 
                subparagraph (G), the clinical trial information for a 
                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.
                    ``(G) Updates.--The responsible party for an 
                applicable clinical trial shall submit to the Director 
                of NIH for inclusion in the registry database periodic 
                updates to reflect changes to the clinical trial 
                information submitted under this paragraph. Such 
                updates--
                            ``(i) shall be provided not less than once 
                        every six months until information on the 
                        results of the trial is submitted under 
                        paragraph (3);
                            ``(ii) shall include identification of the 
                        dates of any such changes;
                            ``(iii) not later than 30 days after the 
                        enrollment status of such clinical trial 
                        changes, shall include an update of the 
                        enrollment status; and
                            ``(iv) not later than 30 days after the 
                        completion date of the clinical trial, shall 
                        include a report to the Director that such 
                        clinical trial is complete.
            ``(3) Clinical trials results database.--
                    ``(A) 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').
                    ``(B) Searchable categories.--The Director of NIH 
                shall ensure that the public may search the entries in 
                the results database by 1 or more of the following:
                            ``(i) The indication studied in the 
                        clinical trial, using Medical Subject Headers 
                        (MeSH) descriptors.
                            ``(ii) The safety issue studied in the 
                        clinical trial.
                            ``(iii) Whether an application for the 
                        tested indication is approved, pending 
                        approval, withdrawn, or not submitted.
                            ``(iv) The phase of the clinical trial.
                            ``(v) The name of the drug or device that 
                        is the subject of the clinical trial.
                            ``(vi) Within the documents described in 
                        subclauses (II) and (III) of subparagraph 
                        (C)(ii), the following information, as 
                        applicable:
                                    ``(I) The sponsor of the clinical 
                                trial.
                                    ``(II) Each financial sponsor of 
                                the clinical trial.
                    ``(C) 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 a 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 (v) of subparagraph 
                                (B).
                                    ``(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) With respect to the group of 
                                subjects receiving the drug or device 
                                involved, and each comparison group of 
                                subjects, the percentage of individuals 
                                who ceased participation as subjects 
                                and their reasons for ceasing 
                                participation.
                                    ``(V) With respect to an individual 
                                who is not an employee of the 
                                responsible party for the clinical 
                                trial or of the manufacturer of the 
                                drug or device involved, information 
                                (to the extent not submitted under 
                                paragraph (2)(B)(vi)) on any agreement 
                                that the responsible party or 
                                manufacturer has entered into with such 
                                individual that restricts in any manner 
                                the ability of the individual--
                                            ``(aa) to discuss the 
                                        results of the trial at a 
                                        scientific meeting or any other 
                                        public or private forum; or
                                            ``(bb) to publish the 
                                        results of the trial, or a 
                                        description or discussion of 
                                        the results of the trial, in a 
                                        scientific or academic journal.
                                    ``(VI) A link to available peer-
                                reviewed publications based on the 
                                results of the clinical trial.
                                    ``(VII) The completion date of the 
                                clinical trial.
                                    ``(VIII) 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.
                    ``(D) Timing.--
                            ``(i) In general.--Except as provided in 
                        clauses (ii) and (iii), 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 earlier 
                        of--
                                    ``(I) the estimated completion date 
                                of the trial, as submitted under 
                                paragraph (2)(B); or
                                    ``(II) the actual date of the 
                                completion, or termination before 
                                completion, of the trial, as 
                                applicable.
                            ``(ii) Extensions.--The Director of NIH may 
                        provide an extension of the deadline for 
                        submission of clinical trial information under 
                        clause (i) if the responsible party for the 
                        trial submits to the Director a written request 
                        that demonstrates good cause for the extension 
                        and provides an estimate of the date on which 
                        the information will be submitted. The Director 
                        of NIH may grant more than one such extension 
                        for the clinical trial involved.
                            ``(iii) Updates.--The responsible party for 
                        an applicable clinical trial shall submit to 
                        the Director of NIH for inclusion in the 
                        results database periodic updates to reflect 
                        changes in the clinical trial information 
                        submitted under this paragraph. Such updates--
                                    ``(I) shall be provided not less 
                                frequently than once every six months 
                                during the 10-year period beginning on 
                                the date on which information is due 
                                under clause (i); and
                                    ``(II) shall identify the dates on 
                                which the changes were made; and
                                    ``(III) shall include, not later 
                                than 30 days after any change in the 
                                regulatory status of the drug or device 
                                involved, an update informing the 
                                Director of NIH of such change.
                    ``(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 a clinical trial to 
                        include information from any source other than 
                        such clinical trial.
                    ``(F) Public availability of results.--
                            ``(i) Pre-approval studies.--Except as 
                        provided in clause (v), 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, or the device is 
                        initially cleared under section 510(k) or 
                        approved under section 515 of the Federal Food, 
                        Drug, and Cosmetic 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 or device is 
                                approved under such section 505, 
                                licensed under such section 351, 
                                cleared under such section 510(k), or 
                                approved under such section 515, as 
                                applicable; or
                                    ``(II) the Secretary issues a not 
                                approvable letter or a not 
                                substantially equivalent letter for the 
                                drug or device under such section 505, 
                                351, 510(k), or 515, as applicable.
                            ``(ii) Medical and clinical pharmacology 
                        reviews of pre-approval studies.--Not later 
                        than 90 days after the date applicable under 
                        subclause (I) or (II) of clause (i) with 
                        respect to an applicable clinical trial, the 
                        Director of NIH shall make publicly available 
                        on the results database a summary of the 
                        available medical and clinical pharmacology 
                        reviews conducted by the Food and Drug 
                        Administration for such trial.
                            ``(iii) Post-approval studies.--Except as 
                        provided in clauses (iv) and (v), with respect 
                        to an applicable clinical trial that is 
                        completed after the drug is initially approved 
                        under such section 505 or licensed under such 
                        section 351, or the device is initially cleared 
                        under such section 510(k) or approved under 
                        such section 515, 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.
                            ``(iv) Seeking approval of a new use for 
                        the drug or device.--
                                    ``(I) In general.--If the 
                                manufacturer of the drug or device is 
                                the sponsor or a financial sponsor of 
                                an 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, licensing under such 
                                section 351, clearance under such 
                                section 510(k), or approval under such 
                                section 515 for the use studied in such 
                                clinical trial (which use is not 
                                included in the labeling of the 
                                approved drug or device), 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 new use of the 
                                        drug or device is approved 
                                        under such section 505, 
                                        licensed under such section 
                                        351, cleared under such section 
                                        510(k), or approved under such 
                                        section 515;
                                            ``(bb) the Secretary issues 
                                        a not approvable letter or a 
                                        not substantially equivalent 
                                        letter for the new use of the 
                                        drug or device under such 
                                        section 505, 351, 510(k), or 
                                        515; or
                                            ``(cc) the application or 
                                        premarket notification under 
                                        such section 505, 351, 510(k), 
                                        or 515 is withdrawn.
                                    ``(II) Limitation on 
                                certification.--If a manufacturer makes 
                                a certification under subclause (I) 
                                with respect to a clinical trial, the 
                                manufacturer shall make 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.
                                    ``(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 
                                the certification referred to in 
                                subclause (I) was made 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) Medical and clinical 
                                pharmacology reviews.--Not later than 
                                90 days after the date applicable under 
                                item (aa), (bb), or (cc) of subclause 
                                (I) or subclause (III) with respect to 
                                an applicable clinical trial, the 
                                Director of NIH shall make publicly 
                                available on the results database a 
                                summary of the available medical and 
                                clinical pharmacology reviews conducted 
                                by the Food and Drug Administration for 
                                such trial.
                            ``(v) Seeking publication.--
                                    ``(I) In general.--If the principal 
                                investigator of an 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) Limitations.--The clinical 
                                trial information subject to subclause 
                                (I)--
                                            ``(aa) 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; 
                                        and
                                            ``(bb) shall not be 
                                        required to be made publicly 
                                        available under section 552 of 
                                        title 5, United States Code 
                                        (commonly known as the `Freedom 
                                        of Information Act'), prior to 
                                        the date applicable to such 
                                        clinical trial information 
                                        under this clause.
                    ``(G) 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 (iv) or 
                (v) of subparagraph (F), 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) Updates; tracking of changes in submitted 
        information.--The Director of NIH shall ensure that updates 
        submitted to the Director under paragraphs (2)(G) and (3)(D) do 
        not result in the removal from the registry database or the 
        results database of the original submissions or of any 
        preceding updates, and that information in such databases is 
        presented in a manner that enables users to readily access each 
        original submission and to track the changes made by the 
        updates.
            ``(5) 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 
                        noncompliance and allow such grantee 30 days to 
                        correct such noncompliance 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; 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) or the 
                        results database under paragraph (3) shall 
                        include a link to the corresponding entry in 
                        the results database or the registry database, 
                        respectively.
                            ``(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 
                                noncompliance 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 
                                applicable 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 paragraphs, as 
                        applicable--
                                    ``(I) when considering a drug or 
                                device for an exemption under section 
                                505(i) or section 520(g) of the Federal 
                                Food, Drug, and Cosmetic Act; and
                                    ``(II) prior to filing an 
                                application or premarket notification 
                                under section 505, 510(k), or 515 of 
                                the Federal Food, Drug, and Cosmetic 
                                Act or section 351 of this Act, that 
                                includes information from such clinical 
                                trial.
                            ``(ii) Notification.--If the Secretary 
                        determines under clause (i) that clinical trial 
                        information has not been submitted as required 
                        by paragraph (2) or (3), the Secretary shall 
                        notify the applicant and the responsible party 
                        of such noncompliance and require submission of 
                        such information within 30 days.
                            ``(iii) Refusal to file.--If the 
                        responsible party does not remedy such 
                        noncompliance within 30 days of receipt of 
                        notification under clause (ii), the Secretary 
                        shall refuse to file, approve, or clear such 
                        application or premarket notification.
                    ``(D) Content review.--
                            ``(i) In general.--To ensure that the 
                        summary documents described in paragraph (3)(C) 
                        are non-promotional, and are not false or 
                        misleading in any particular under paragraph 
                        (3)(E), 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 or 515 of the Federal Food, 
                                        Drug, and Cosmetic Act or under 
                                        section 351 of this Act or a 
                                        premarket notification under 
                                        section 510(k) of the Federal 
                                        Food, Drug, and Cosmetic Act; 
                                        or
                                            ``(bb) in an annual status 
                                        report on the drug or device 
                                        under such application;
                                    ``(II) acting 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 noncompliance.--If the 
                        Secretary 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 noncompliance by 
                        submitting the required revised clinical trial 
                        information within 30 days of such 
                        notification.
            ``(6) Penalties for noncompliance.--
                    ``(A) In general.--The following acts and the 
                causing thereof are deemed to be prohibited by section 
                301 of the Federal Food, Drug, and Cosmetic Act:
                            ``(i) The failure to submit clinical trial 
                        information as required by this section.
                            ``(ii) The submission of clinical trial 
                        information under this section that is 
                        promotional or false or misleading in any 
                        particular in violation of paragraph (2)(E) or 
                        (3)(E).
                    ``(B) Considerations.--In determining whether to 
                apply a penalty under the Federal Food, Drug, and 
                Cosmetic Act or under subparagraph (C) of this 
                paragraph for a violation described in subparagraph 
                (A), the Secretary, acting through the Commissioner of 
                Food and Drugs, shall consider--
                            ``(i) whether the responsible party 
                        promptly corrects the noncompliance when 
                        provided notice;
                            ``(ii) whether the responsible party has 
                        engaged in a pattern or practice of 
                        noncompliance; and
                            ``(iii) the extent to which the 
                        noncompliance involved may have significantly 
                        misled health care providers or patients 
                        concerning the safety or effectiveness of the 
                        drug involved.
                    ``(C) Civil penalties.--
                            ``(i) In general.--A person is subject to a 
                        civil penalty in accordance with this 
                        subparagraph if the person commits a violation 
                        described in subparagraph (A) and fails to 
                        correct the violation by the end of the 30-day 
                        period described in clause (ii).
                            ``(ii) Notification.--If a person is in 
                        violation of subparagraph (A), the Secretary 
                        shall notify the person of such noncompliance 
                        and give the person a 30-day period to correct 
                        such violation before imposing a civil penalty 
                        under this subparagraph.
                            ``(iii) Amount of penalty.--The amount of a 
                        civil penalty under this paragraph shall be not 
                        more than a total of $15,000 for all violations 
                        adjudicated in a single proceeding in the case 
                        of an individual, and not more than $10,000 per 
                        day until the violation is corrected in the 
                        case of any other person, except that if the 
                        person is a nonprofit entity the penalty may 
                        not exceed a total of $15,000 for all 
                        violations adjudicated in a single proceeding.
                            ``(iv) Procedures.--The provisions of 
                        paragraphs (4) through (6) of section 303(f) of 
                        the Federal Food, Drug, and Cosmetic Act apply 
                        to the imposition of a penalty under this 
                        paragraph to the same extent and in the same 
                        manner as such provisions apply to a penalty 
                        imposed under such section 303(f).
            ``(7) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection 
        $10,000,000 for each fiscal year.''.
    (b) Conforming Amendments.--
            (1) Investigational new drugs.--Section 505(i) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is 
        amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (C), by striking 
                        ``and'' after the semicolon;
                            (ii) in subparagraph (D)--
                                    (I) by aligning the indentation of 
                                such subparagraph with the indentation 
                                of subparagraphs (A), (B), and (C); and
                                    (II) 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(i) of the Public Health Service Act 
        for inclusion in the registry database and the results database 
        described in such section.'';
                    (B) 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(i) of the Public Health Service Act.''; and
                    (C) 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(i) of the Public Health Service Act.''.
            (2) Refusal to approve new drug application.--Section 
        505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(d)) is amended--
                    (A) 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 as required by section 402(i) 
                of the Public Health Service Act;''; and
                    (B) in the second sentence, by striking ``clauses 
                (1) through (6)'' and inserting ``paragraphs (1) 
                through (8)''.
            (3) Investigational new devices.--Subparagraph (B) of 
        section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360j(g)(2)) is amended--
                    (A) by redesignating clause (iii) as clause (iv); 
                and
                    (B) by inserting after clause (ii) the following:
                            ``(iii) A requirement that the person 
                        applying for an exemption for a device assure 
                        that such person is in compliance with the 
                        requirements of section 402(i) of the Public 
                        Health Service Act for the submission of 
                        clinical trial information for inclusion in the 
                        registry database and the results database 
                        described in such section.''.
            (4) Refusal to clear new device premarket notification 
        report.--Subsection (k) of section 510 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
                    (A) in paragraph (1), by striking ``and'' at the 
                end; and
                    (B) in paragraph (2), by striking the period at the 
                end and inserting ``, and''; and
                    (C) by adding at the end the following:
            ``(3) action taken by such person to comply with 
        requirements under section 402(i) of the Public Health Service 
        Act for the submission of clinical trial information for 
        inclusion in the registry database and the results database 
        described in such section.''.
            (5) Refusal to approve new device application.--Paragraph 
        (2) of section 515(d) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360e(d)) is amended--
                    (A) in subparagraph (D), by striking ``or'' at the 
                end;
                    (B) in subparagraph (E), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by adding at the end the following:
                    ``(F) the applicant is in violation of the 
                requirements under section 402(i) of the Public Health 
                Service Act for the submission of clinical trial 
                information for inclusion in the registry database or 
                the results database described in such section.''.
    (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(i)(2) of the Public Health Service Act, as 
amended by this section) and required to be submitted for inclusion in 
the clinical trial registry database described in such section.
    (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(i) of the Public Health Service Act (as amended by 
        this section), that relates to a use of a drug or device not 
        included in the official labeling of the approved drug or 
        device shall not be construed by the Secretary or in any 
        administrative or judicial proceeding, as evidence of a new 
        intended use of the drug or device that is different from the 
        intended use of the drug or device set forth in the official 
        labeling of the drug or device. The availability of clinical 
        trial information through the databases under paragraphs (2) 
        and (3) of such section 402(i), if submitted in compliance with 
        such section 402(i), shall not be considered as labeling, 
        adulteration, or misbranding of the drug or device 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 
        and devices in accordance with section 402(i) of the Public 
        Health Service Act (as amended by subsection (a)).
            (2) Clinical trials initiated prior to operation of 
        registry database.--The responsible party (as defined in such 
        section 402(i)) for an applicable clinical trial (as defined in 
        such section 402(i)) 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(i)) for an applicable clinical trial (as defined in such 
        section 402(i)) 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 paragraph (2) of such section 402(i).
            (4) Trials completed before operation of results 
        database.--
                    (A) In general.--Paragraph (3) of such section 
                402(i) 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(i)) that--
                            (i) involves a drug to treat a serious or 
                        life-threatening condition; and
                            (ii) is completed between the date of 
                        enactment of this Act 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(i) 
                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 that is completed between the date of enactment 
                of this Act and such date of establishment under 
                paragraph (1).
            (5) Trials completed after establishment of results 
        database.--Paragraph (3) of such section 402(i) shall apply to 
        any clinical trial that is completed after the date that the 
        results database is established under paragraph (1) of this 
        subsection.
            (6) Retroactivity of database.--
                    (A) Voluntary submissions.--The Secretary of Health 
                and Human Services (referred to in this paragraph as 
                the ``Secretary'') shall establish procedures and 
                mechanisms to allow for the voluntary submission to the 
                Secretary--
                            (i) of clinical trial information for 
                        inclusion in the registry database (as defined 
                        in such section 402(i)) on applicable clinical 
                        trials (as defined in such section 402(i)) 
                        initiated before the date of the enactment of 
                        this Act; and
                            (ii) of clinical trial information for 
                        inclusion in the results database (as defined 
                        in such section 402(i)) on applicable clinical 
                        trials (as defined in such section 402(i)) 
                        completed before the date of the enactment of 
                        this Act.
                    (B) Required submissions.--Notwithstanding the 
                preceding paragraphs of this subsection, in any case in 
                which the Secretary determines that submission of 
                clinical trial information for an applicable clinical 
                trial (as defined in such section 402(i)) described in 
                clause (i) or (ii) of subparagraph (A) is in the 
                interest of the public health--
                            (i) the Secretary may require that such 
                        information be submitted to the Secretary in 
                        accordance with such section 402(i); and
                            (ii) failure to comply with such a 
                        requirement shall be treated as a violation of 
                        the corresponding requirement of such section 
                        402(i).
            (7) Funding restrictions.--Subparagraph (A) of paragraph 
        (5) of such section 402(i) 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.
            (8) 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(i) and 
                whether such approach is--
                            (i) that such registry database should 
                        expand and build upon the database described in 
                        section 402(i) 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(i) (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(i) (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) Advisory committee.--The term `advisory committee' 
        means an advisory committee under the Federal Advisory 
        Committee Act that provides advice or recommendations to the 
        Secretary regarding activities of the Food and Drug 
        Administration.
            ``(2) Financial interest.--The term `financial interest' 
        means a financial interest under section 208(a) of title 18, 
        United States Code.
            ``(3) Industry financial interest.--The term `industry 
        financial interest', with respect to appointment for a term to 
        an advisory committee, means an interest in a company that is a 
        member of the relevant industry that would be a financial 
        interest were an advisory committee to consider a particular 
        matter involving such company.
            ``(4) Relevant industry.--The term `relevant industry' 
        means--
                    ``(A) with respect to an advisory committee that 
                advises the Secretary on human drugs, biologics, or 
                devices, the pharmaceutical, biotechnology, and device 
                industries;
                    ``(B) with respect to an advisory committee that 
                advises the Secretary on animal drugs or devices, the 
                animal drug and the animal device industries; and
                    ``(C) with respect to an advisory committee that 
                advises the Secretary on foods, the food industry.
    ``(b) Appointments to Advisory Committees.--
            ``(1) Disclosure of industry financial interests.--Each 
        individual under consideration for a term appointment to an 
        advisory committee shall disclose to the Secretary all industry 
        financial interests.
            ``(2) Disclosures not publicly available.--No disclosure 
        required under paragraph (1) shall be made available to the 
        public.
            ``(3) Evaluation and criteria.--When considering a term 
        appointment to an advisory committee, the Secretary--
                    ``(A) shall review the expertise and the industry 
                financial interests, as disclosed under paragraph (1), 
                of each individual under consideration for the 
                appointment, so as to appoint the individuals, from 
                among those individuals under consideration for 
                appointment, who are the most qualified relative to 
                their industry financial interests that could require a 
                written determination as referred to in section 
                208(b)(1) of title 18, United States Code, a written 
                certification as referred to in section 208(b)(3) of 
                title 18, United States Code, or a waiver as referred 
                to in subsection (c)(3) for service on the committee at 
                a meeting of the committee; and
                    ``(B) may appoint 2 or more qualified individuals 
                with similar expertise and whose industry financial 
                interests are nonoverlapping or minimally overlapping, 
                so as to minimize the likelihood that an advisory 
                committee will need the expertise of an appointed 
                individual who requires a written determination as 
                referred to in section 208(b)(1) of title 18, United 
                States Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in subsection (c)(3) for service 
                on the committee at a meeting of the committee.
    ``(c) Granting and Disclosure of Waivers.--
            ``(1) In general.--Not later then 45 days before a meeting 
        of an advisory committee, each member of the committee shall 
        disclose to the Secretary all financial interests in accordance 
        with section 208(b) of title 18, United States Code.
            ``(2) Financial gain of advisory committee member or family 
        member.--No member of an advisory committee may vote with 
        respect to any matter considered by the advisory committee if 
        such member or an immediate family member of such member could 
        gain financially from the advice given to the Secretary with 
        respect to such matter.
            ``(3) Waiver.--In addition to considerations under section 
        208(b) of title 18, United States Code, the Secretary may grant 
        a waiver of a conflict of interest requirement if such waiver 
        is necessary to afford the advisory committee essential 
        expertise.
            ``(4) Limitation.--In no case may the Secretary grant a 
        waiver under paragraph (3) for a member of an advisory 
        committee if the scientific work of such member is under 
        consideration by the committee.
            ``(5) Disclosure of waiver.--
                    ``(A) More than 15 days in advance.--As soon as 
                practicable, but in no case later than 15 days prior to 
                a meeting of an advisory committee to which a written 
                determination as referred to in section 208(b)(1) of 
                title 18, United States Code, a written certification 
                as referred to in section 208(b)(3) of title 18, United 
                States Code, or a waiver as referred to in paragraph 
                (3) applies, the Secretary shall disclose (other than 
                information exempted from disclosure under section 552 
                of title 5, United States Code, and section 552a of 
                title 5, United States Code (popularly known as the 
                Freedom of Information Act and the Privacy Act of 1974, 
                respectively)) on the Internet website of the Food and 
                Drug Administration--
                            ``(i) the financial interests of the 
                        advisory committee member to which such 
                        determination, certification, or waiver 
                        applies; and
                            ``(ii) the reasons of the Secretary for 
                        such determination, certification, or waiver.
                    ``(B) Less than 15 days in advance.--In the case of 
                a financial interest that becomes known to the 
                Secretary less than 30 days prior to a meeting of an 
                advisory committee to which a written determination as 
                referred to in section 208(b)(1) of title 18, United 
                States Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (3) applies, the 
                Secretary shall disclose (other than information 
                exempted from disclosure under section 552 of title 5, 
                United States Code, and section 552a of title 5, United 
                States Code) on the Internet website of the Food and 
                Drug Administration, the information described in 
                clauses (i) and (ii) of subparagraph (A) as soon as the 
                Secretary makes such determination, certification, or 
                waiver, but in no event later than the date of such 
                meeting.
    ``(d) Public Record.--The Secretary shall ensure that the public 
record and transcript of each meeting of an advisory committee includes 
the disclosure required under subsection (c)(5) (other than information 
exempted from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code).
    ``(e) Annual Report.--Not later than January 15 of each year, the 
Secretary shall submit a report to the Inspector General of the 
Department of Health and Human Services, the Committee on 
Appropriations and the Committee on Health, Education, Labor, and 
Pensions of the Senate, and the Committee on Appropriations and the 
Committee on Energy and Commerce of the House of Representatives--
            ``(1) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of vacancies on 
        each advisory committee, the number of nominees received for 
        each committee, and the number of such nominees willing to 
        serve;
            ``(2) with respect to such year, the aggregate number of 
        disclosures required under subsection (c)(5) for each meeting 
        of each advisory committee and the percentage of individuals to 
        whom such disclosures did not apply who served on such 
        committee for each such meeting;
            ``(3) with respect to such year, the number of times the 
        disclosures required under subsection (c)(5) occurred under 
        subparagraph (B) of such subsection; and
            ``(4) how the Secretary plans to reduce the number of 
        vacancies reported under paragraph (1) during the fiscal year 
        following such year.''.
    (b) Guidance.--
            (1) Nominations.--Not later than 270 days after the date of 
        enactment of this Act, and after seeking input from 
        professional medical and scientific societies, 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 
        an advisory committee.
            (2) Waiver determinations.--Not later than 270 days after 
        the date of enactment of this Act the Secretary shall issue or 
        revise guidance--
                    (A) that clarifies the circumstances in which the 
                Secretary may make a written determination as referred 
                to in section 208(b)(1) of title 18, United States 
                Code, make a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or 
                grant a waiver as referred to section 712(c)(3) of the 
                Federal Food, Drug, and Cosmetic Act (as added by this 
                section), including those circumstances that--
                            (i) favor the inclusion of an individual on 
                        an advisory committee;
                            (ii) favor making such a determination, 
                        certification, or waiver for an individual on 
                        an advisory committee;
                            (iii) favor limitations on an individual's 
                        ability to act when making such a 
                        determination, certification, or waiver for the 
                        individual on an advisory committee; and
                            (iv) disfavor the inclusion of an 
                        individual on an advisory committee;
                    (B) that defines how financial interests imputed to 
                an individual bear upon his or her eligibility for 
                service on an advisory committee or for service at a 
                meeting of an advisory committee; and
                    (C) to ensure consistency within and among the 
                centers of the Food and Drug Administration in applying 
                section 208(b) of title 18, United States Code, and 
                such section 712(c)(3).
            (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 conduct a review, which may 
        include surveys of past or current members of advisory 
        committees, of the processes of the Food and Drug 
        Administration for--
                    (A) evaluating the financial interests of a member 
                of such an advisory committee while the member serves 
                on such a committee and after the member has served on 
                such a committee; and
                    (B) assuring the completeness and accuracy of 
                information contained in the disclosures described in 
                subsections (b)(1) and (c)(1) of such section 712 of 
                the Federal Food, Drug, and Cosmetic Act (as added by 
                this section).
            (2) Submission of report.--Not later than 18 months after 
        the effective date of this section, the Inspector General of 
        the Department of Health and Human Services shall submit to 
        Congress a report based on the review required under paragraph 
        (1), and include any recommendations for the improvement of 
        such processes.
    (d) Definitions.--For purposes of this section, the terms 
``advisory committee'' and ``financial interest'' have the meaning 
given such terms in section 712 of the Federal Food, Drug, and Cosmetic 
Act (as added by this section).
    (e) 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.
    (f) Effective Date.--The amendments made by this section shall take 
effect on October 1, 2007.
                                 <all>