```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 470 Introduced in Senate (IS)]

109th CONGRESS
  1st Session
                                 S. 470

 To amend the Public Health Service Act to expand the clinical trials 
                            drug data bank.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           February 28, 2005

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

_______________________________________________________________________

                                 A BILL

 
 To amend the Public Health Service Act to expand the clinical trials 
                            drug data bank.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fair Access to Clinical Trials Act 
of 2005'' or the ``FACT Act''.

SEC. 2. PURPOSE.

    It is the purpose of this Act--
            (1) to create a publicly accessible national data bank of 
        clinical trial information comprised of a clinical trial 
        registry and a clinical trial results database;
            (2) to foster transparency and accountability in health-
        related intervention research and development;
            (3) to maintain a clinical trial registry accessible to 
        patients and health care practitioners seeking information 
        related to ongoing clinical trials for serious or life-
        threatening diseases and conditions; and
            (4) to establish a clinical trials results database of all 
        publicly and privately funded clinical trial results regardless 
        of outcome, that is accessible to the scientific community, 
        health care practitioners, and members of the public.

SEC. 3. CLINICAL TRIALS DATA BANK.

    (a) In General.--Section 402(j) of the Public Health Service Act 
(42 U.S.C. 282(j)) is amended--
            (1) in paragraph (1)(A), by striking ``for drugs for 
        serious or life-threatening diseases and conditions'';
            (2) in paragraph (2), by striking ``available to 
        individuals with serious'' and all that follows through the 
        period and inserting ``accessible to patients, other members of 
        the public, health care practitioners, researchers and the 
        scientific community. In making information about clinical 
        trials publicly available, the Secretary shall seek to be as 
        timely and transparent as possible.'';
            (3) by redesignating paragraphs (4) and (5), as paragraphs 
        (8) and (9), respectively;
            (4) by striking paragraph (3) and inserting the following:
    ``(3) The data bank shall include the following:
            ``(A)(i) A registry of clinical trials (in this 
        subparagraph referred to as the `registry') of health-related 
        interventions (whether federally or privately funded).
            ``(ii) The registry shall include information for all 
        clinical trials conducted to test the safety or effectiveness 
        (including comparative effectiveness) of any drug, biological 
        product, or device (including those drugs, biological products, 
        or devices approved or cleared by the Secretary) intended to 
        treat serious or life-threatening diseases and conditions, 
        except those Phase I clinical trials conducted to test solely 
        the safety of an unapproved drug or unlicensed biological 
        product, or pilot or feasibility studies conducted to confirm 
        the design and operating specifications of an unapproved or not 
        yet cleared medical device. For purposes of this section, Phase 
        I clinical trials are trials described in section 313.12(a) of 
        title 21, Code of Federal Regulations (or any successor 
        regulations).
            ``(iii) The registry may include information for--
                    ``(I) Phase I clinical trials conducted to test 
                solely the safety of an unapproved drug or unlicensed 
                biological product, or pilot or feasibility studies 
                conducted to confirm the design and operating 
                specifications of an unapproved or not yet cleared 
                medical device with the consent of the responsible 
                person; and
                    ``(II) clinical trials of other health-related 
                interventions with the consent of the responsible 
                person.
            ``(iv) The information to be included in the registry under 
        this subparagraph shall include the following:
                    ``(I) Descriptive information, including a brief 
                title, trial description in lay terminology, trial 
                phase, trial type, trial purpose, description of the 
                primary and secondary clinical outcome measures to be 
                examined in the trial, the time at which the outcome 
                measures will be assessed, and the dates and details of 
                any revisions to such outcomes.
                    ``(II) Recruitment information, including 
                eligibility and exclusion criteria, a description of 
                whether, and through what procedure, the manufacturer 
                or sponsor of the investigation of a new drug will 
                respond to requests for protocol exception, with 
                appropriate safeguards, for single-patient and expanded 
                protocol use of the new drug, particularly in children, 
                a statement as to whether the trial is closed to 
                enrollment of new patients, overall trial status, 
                individual site status, and estimated completion date. 
                For purposes of this section the term `completion date' 
                means the date of the last visit by subjects in the 
                trial for the outcomes described in subclause (I).
                    ``(III) Location and contact information, including 
                the identity of the responsible person.
                    ``(IV) Administrative data, including the study 
                sponsor and the study funding source.
                    ``(V) Information pertaining to experimental 
                treatments for serious or life threatening diseases and 
                conditions (whether federally or privately funded) that 
                may be available--
                            ``(aa) under a treatment investigational 
                        new drug application that has been submitted to 
the Secretary under section 360bbb(c) of title 21, Code of Federal 
Regulations; or
                            ``(bb) as a Group C cancer drug (as defined 
                        by the National Cancer Institute).
            ``(B)(i) A clinical trials results database (in this 
        subparagraph referred to as the `database') of health-related 
        interventions (whether federally or privately funded).
            ``(ii) The database shall include information for all 
        clinical trials conducted to test the safety or effectiveness 
        (including comparative effectiveness) of any drug, biological 
        product, or device (including those drugs, biological products, 
        or devices approved or cleared by the Secretary), except those 
        Phase I clinical trials conducted to test solely the safety of 
        an unapproved drug or unlicensed biological product, or pilot 
        or feasibility studies conducted to confirm the design and 
        operating specifications of an unapproved or not yet cleared 
        medical device.
            ``(iii) The database may include information for--
                    ``(I) Phase I clinical trials conducted to test 
                solely the safety of an unapproved drug or unlicensed 
                biological product, or pilot or feasibility studies 
                conducted to confirm the design and operating 
                specifications of an unapproved or not yet cleared 
                medical device with the consent of the responsible 
                person; and
                    ``(II) clinical trials of other health-related 
                interventions with the consent of the responsible 
                person.
            ``(iv) The information to be included in the database under 
        this subparagraph shall include the following:
                    ``(I) Descriptive information, including--
                            ``(aa) a brief title;
                            ``(bb) the drug, biological product or 
                        device to be tested;
                            ``(cc) a trial description in lay 
                        terminology;
                            ``(dd) the trial phase;
                            ``(ee) the trial type;
                            ``(ff) the trial purpose;
                            ``(gg) the estimated completion date for 
                        the trial; and
                            ``(hh) the study sponsor and the study 
                        funding source.
                    ``(II) A description of the primary and secondary 
                clinical outcome measures to be examined in the trial, 
                the time at which the outcome measures will be 
                assessed, and the dates and details of any revisions to 
                such outcomes.
                    ``(III) The actual completion date of the trial and 
                the reasons for any difference from such actual date 
                and the estimated completion date submitted pursuant to 
                subclause (I)(hh). If the trial is not completed, the 
                termination date and reasons for such termination.
                    ``(IV) A summary of the results of the trial in a 
                standard, non-promotional summary format (such as ICHE3 
                template form), including the trial design and 
                methodology, results of the primary and secondary 
                outcome measures as described in subclause (II), 
                summary data tables with respect to the primary and 
                secondary outcome measures, including information on 
                the statistical significance or lack thereof of such 
                results.
                    ``(V) Safety data concerning the trial (including a 
                summary of all adverse events specifying the number and 
                type of such events, data on prespecified adverse 
                events, data on serious adverse events, and data on 
                overall deaths).
                    ``(VI) Any publications in peer reviewed journals 
                relating to the trial. If the trial results are 
                published in a peer reviewed journal, the database 
                shall include a citation to and, when available, a link 
                to the journal article.
                    ``(VII) A description of the process used to review 
                the results of the trial, including a statement about 
                whether the results have been peer reviewed by 
                reviewers independent of the trial sponsor.
                    ``(VIII) If the trial addresses the safety, 
                effectiveness, or benefit of a use not described in the 
                approved labeling for the drug, biological product, or 
                device, a statement, as appropriate, displayed 
                prominently at the beginning of the data in the 
                registry with respect to the trial, that the Food and 
                Drug Administration--
                            ``(aa) is currently reviewing an 
                        application for approval of such use to 
                        determine whether the use is safe and 
                        effective;
                            ``(bb) has disapproved an application for 
                        approval of such use;
                            ``(cc) has reviewed an application for 
                        approval of such use but the application was 
                        withdrawn prior to approval or disapproval; or
                            ``(dd) has not reviewed or approved such 
                        use as safe and effective.
                    ``(IX) If data from the trial has not been 
                submitted to the Food and Drug Administration, an 
                explanation of why it has not been submitted.
                    ``(X) A description of the protocol used in such 
                trial to the extent necessary to evaluate the results 
                of such trial.
    ``(4)(A) Not later than 90 days after the date of the completion of 
the review by the Food and Drug Administration of information submitted 
by a sponsor in support of a new drug application, or a supplemental 
new drug application, whether or not approved by the Food and Drug 
Administration, the Commissioner of Food and Drugs shall make available 
to the public the full reviews conducted by the Administration of such 
application.
    ``(B) Not later than 90 days after the date of the completion of a 
written consultation on a drug concerning the drug's safety conducted 
by the Office of Drug Safety, regardless of whether initiated by such 
Office or outside of the Office, the Commissioner of Food and Drugs 
shall make available to the public a copy of such consultation in full.
    ``(C) Nothing in this paragraph shall be construed to alter or 
amend section 301(j) or section 1905 of title 18, United States Code.
    ``(D) This paragraph shall supersede section 552 of title 5, United 
States Code.
    ``(5) The information described in subparagraphs (A) and (B) of 
paragraph (3) shall be in a format that can be readily accessed and 
understood by members of the general public, including patients seeking 
to enroll as subjects in clinical trials.
    ``(6) The Secretary shall assign each clinical trial a unique 
identifier to be included in the registry and in the database described 
in subparagraphs (A) and (B) of paragraph (3). To the extent 
practicable, this identifier shall be consistent with other 
internationally recognized and used identifiers.
    ``(7) To the extent practicable, the Secretary shall ensure that 
where the same information is required for the registry and the 
database described in subparagraphs (A) and (B) of paragraph (3), a 
process exists to allow the responsible person to make only one 
submission.''; and
            (5) by adding at the end the following:
    ``(10) In this section, the term `clinical trial' with respect to 
the registry and the database described in subparagraphs (A) and (B) of 
paragraph (3) means a research study in human volunteers to answer 
specific health questions, including treatment trials, prevention 
trials, diagnostic trials, screening trials, and quality of life 
trials.''.
    (b) Actions of Secretary Regarding Clinical Trials.--Section 402 of 
the Public Health Service Act (42 U.S.C. 282) is amended--
            (1) by redesignating subsections (k) and (l) as subsections 
        (q) and (r), respectively; and
            (2) by inserting after subsection (j), the following:
    ``(k) Federally Supported Trials.--
            ``(1) All federally supported trials.--With respect to any 
        clinical trial described in subsection (j)(3)(B) that is 
        supported solely by a grant, contract, or cooperative agreement 
        awarded by the Secretary, the principal investigator of such 
        trial shall, not later than the date specified in paragraph 
        (2), submit to the Secretary--
                    ``(A) the information described in subclauses (II) 
                through (X) of subsection (j)(3)(B)(iv), and with 
                respect to clinical trials in progress on the date of 
                enactment of the FACT Act, the information described in 
                subclause (I) of subsection (j)(3)(B)(iv); or
                    ``(B) a statement containing information sufficient 
                to demonstrate to the Secretary that the information 
                described in subparagraph (A) cannot reasonably be 
                submitted, along with an estimated date of submission 
                of the information described in such subparagraph.
            ``(2) Date specified.--The date specified in this paragraph 
        shall be the date that is 1 year from the earlier of--
                    ``(A) the estimated completion date of the trial, 
                as submitted under subsection (j)(3)(B)(vi)(I)(hh); or
                    ``(B) the actual date of the completion or 
                termination of the trial.
            ``(3) Condition of federal grants, contracts, and 
        cooperative agreements.--
                    ``(A) Certification of compliance.--To be eligible 
                to receive a grant, contract, or cooperative agreement 
                from the Secretary for the conduct or support of a 
                clinical trial described in subsection (j)(3)(B), the 
                principal investigator involved shall certify to the 
                Secretary that--
                            ``(i) such investigator shall submit data 
                        to the Secretary in accordance with this 
                        subsection; and
                            ``(ii) such investigator has complied with 
                        the requirements of this subsection with 
                        respect to other clinical trials conducted by 
                        such investigator after the date of enactment 
                        of the FACT Act.
                    ``(B) Failure to submit certification.--An 
                investigator that fails to submit a certification as 
                required under subparagraph (A) shall not be eligible 
                to receive a grant, contract, or cooperative agreement 
                from the Secretary for the conduct or support of a 
                clinical trial described in subsection (j)(3)(B).
                    ``(C) Failure to comply with certification.--If, by 
                the date specified in paragraph (2), the Secretary has 
                not received the information or statement described in 
                paragraph (1), the Secretary shall--
                            ``(i) transmit to the principal 
                        investigator involved a notice specifying the 
                        information or statement required to be 
                        submitted to the Secretary and stating that 
                        such investigator shall not be eligible to 
                        receive further funding from the Secretary if 
                        such information or statement is not submitted 
                        to the Secretary within 30 days of the date on 
                        which such notice is transmitted; and
                            ``(ii) include and prominently display, 
                        until such time as the Secretary receives the 
                        information or statement described in paragraph 
                        (1), as part of the record of such trial in the 
                        database described in subsection (j), a notice 
                        stating that the results of such trials have 
                        not been reported as required by law.
                    ``(D) Failure to comply with notice.--If by the 
                date that is 30 days after the date on which the notice 
                described in subparagraph (C) is transmitted, the 
                Secretary has not received from the principal 
                investigator involved the information or statement 
                required pursuant to such notice, the Secretary may not 
                award a grant, contract, cooperative agreement, or any 
                other award to such principal investigator until such 
                principal investigator submits to the Secretary the 
                information or statement required pursuant to such 
                notice.
                    ``(E) Submission of statement but not 
                information.--
                            ``(i) In general.--If by the date specified 
                        in paragraph (2), the Secretary has received a 
                        statement described in paragraph (1)(B) but not 
                        the information described in paragraph (1)(A), 
                        the Secretary shall transmit to the principal 
                        investigator involved a notice stating that 
                        such investigator shall submit such information 
                        by the date determined by the Secretary in 
                        consultation with such investigator.
                            ``(ii) Failure to comply with 
                        certification.--If, by the date specified by 
                        the Secretary in the notice under clause (i), 
                        the Secretary has not received the information 
                        described in paragraph (1)(B), the Secretary 
                        shall--
                                    ``(I) transmit to the principal 
                                investigator involved a notice 
                                specifying the information required to 
                                be submitted to the Secretary and 
                                stating that such investigator shall 
                                not be eligible to receive further 
                                funding from the Secretary if such 
                                information is not submitted to the 
                                Secretary within 30 days of the date on 
                                which such notice is transmitted; and
                                    ``(II) include and prominently 
                                display, until such time as the 
                                Secretary receives the information 
                                described in paragraph (1)(B), as part 
                                of the record of such trial in the 
                                database described in subsection (j), a 
                                notice stating that the results of such 
                                trials have not been reported as 
                                required by law.
                    ``(F) Failure to comply with notice.--If by the 
                date that is 30 days after the date on which the notice 
                described in subparagraph (E)(ii)(I) is transmitted, 
                the Secretary has not received from the principal 
                investigator involved the information required pursuant 
                to such notice, the Secretary may not award a grant, 
                contract, cooperative agreement, or any other award to 
                such principal investigator until such principal 
                investigator submits to the Secretary the information 
                required pursuant to such notice.
                    ``(G) Rule of construction.--For purposes of this 
                paragraph, limitations on the awarding of grants, 
                contracts, cooperative agreements, or any other awards 
                to principal investigators for violations of this 
                paragraph shall not be construed to include any funding 
                that supports the clinical trial involved.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to prevent an investigator other than the 
        investigator described in paragraph (3)(F) from receiving an 
ongoing award, contract, or cooperative agreement.
            ``(5) Inclusion in registry.--
                    ``(A) General rule.--The Secretary shall, pursuant 
                to subsection (j)(5), include--
                            ``(i) the data described in subsection 
                        (j)(3)(A) and submitted under the amendments 
                        made by section 4(a) of the FACT Act in the 
                        registry described in subsection (j) as soon as 
                        practicable after receiving such data; and
                            ``(ii) the data described in clause (I) of 
                        subsection (j)(3)(B)(iv) and submitted under 
                        this subsection or the amendments made by 
                        section 4(a) of the FACT Act in the database 
                        described in subsection (j) as soon as 
                        practicable after receiving such data.
                    ``(B) Other data.--
                            ``(i) In general.--The Secretary shall, 
                        pursuant to subsection (j)(5), include the data 
                        described in subclauses (II) through (X) of 
                        subsection (j)(3)(B)(iv) and submitted under 
                        this section in the database described in 
                        subsection (j)--
                                    ``(I) as soon as practicable after 
                                receiving such data; or
                                    ``(II) in the case of data to which 
                                clause (ii) applies, by the date 
                                described in clause (iii).
                            ``(ii) Data described.--This clause applies 
                        to data described in clause (i) if--
                                    ``(I) the principal investigator 
                                involved requests a delay in the 
                                inclusion in the database of such data 
                                in order to have such data published in 
                                a peer reviewed journal; and
                                    ``(II) the Secretary determines 
                                that an attempt will be made to seek 
                                such publication.
                            ``(iii) Date for inclusion in registry.--
                        Subject to clause (iv), the date described in 
                        this clause is the earlier of--
                                    ``(I) the date on which the data 
                                involved is published as provided for 
                                in clause (ii); or
                                    ``(II) the date that is 18 months 
                                after the date on which such data is 
                                submitted to the Secretary.
                            ``(iv) Extension of date.--The Secretary 
                        may extend the 18-month period described in 
                        clause (iii)(II) for an additional 6 months if 
                        the principal investigator demonstrates to the 
                        Secretary, prior to the expiration of such 18-
                        month period, that the data involved has been 
                        accepted for publication by a journal described 
                        in clause (ii)(I).
                            ``(v) Modification of data.--Prior to 
                        including data in the database under clause 
                        (ii) or (iv), the Secretary shall permit the 
                        principal investigator to modify the data 
                        involved.
            ``(6) Memorandum of understanding.--Not later than 6 months 
        after the date of enactment of the FACT Act, the Secretary 
shall seek a memorandum of understanding with the heads of all other 
Federal agencies that conduct clinical trials to include in the 
registry and the database clinical trials sponsored by such agencies 
that meet the requirements of this subsection.
            ``(7) Application to certain persons.--The provisions of 
        this subsection shall apply to a responsible person described 
        in subsections (p)(1)(A)(ii)(II) or (p)(1)(B)(i)(II).
    ``(l) Trials With Non-Federal Support.--
            ``(1) In general.--The responsible person for a clinical 
        trial described in subsection (j)(3)(B) shall, not later than 
        the date specified in paragraph (3), submit to the Secretary--
                    ``(A) the information described in subclauses (II) 
                through (X) of subsection (j)(3)(B)(iv), and with 
                respect to clinical trials in progress on the date of 
                enactment of the FACT Act, the information described in 
                subclause (I) of subsection (j)(3)(B)(iv); or
                    ``(B) a statement containing information sufficient 
                to demonstrate to the Secretary that the information 
                described in subparagraph (A) cannot reasonably be 
                submitted, along with an estimated date of submission 
                of the information described in such subparagraph.
            ``(2) Sanction in case of noncompliance.--
                    ``(A) Initial noncompliance.--If by the date 
                specified in paragraph (3), the Secretary has not 
                received the information or statement required to be 
                submitted to the Secretary under paragraph (1), the 
                Secretary shall--
                            ``(i) transmit to the responsible person 
                        for such trial a notice stating that such 
                        responsible person shall be liable for the 
                        civil monetary penalties described in 
                        subparagraph (B) if the required information or 
                        statement is not submitted to the Secretary 
within 30 days of the date on which such notice is transmitted; and
                            ``(ii) include and prominently display, 
                        until such time as the Secretary receives the 
                        information described in paragraph (1), as part 
                        of the record of such trial in the database 
                        described in subsection (j), a notice stating 
                        that the results of such trials have not been 
                        reported as required by law.
                    ``(B) Civil monetary penalties for noncompliance.--
                            ``(i) In general.--If by the date that is 
                        30 days after the date on which a notice 
                        described in subparagraph (A) is transmitted, 
                        the Secretary has not received from the 
                        responsible person involved the information or 
                        statement required pursuant to such notice, the 
                        Secretary shall, after providing the 
                        opportunity for a hearing, order such 
                        responsible person to pay a civil penalty of 
                        $10,000 for each day after such date that the 
                        information or statement is not submitted.
                            ``(ii) Waivers.--In any case in which a 
                        responsible person described in clause (i) is a 
                        nonprofit entity, the Secretary may waive or 
                        reduce the penalties applicable under such 
                        clause to such person.
                    ``(C) Submission of statement but not 
                information.--
                            ``(i) In general.--If by the date specified 
                        in paragraph (3), the Secretary has received a 
                        statement described in paragraph (1)(B) but not 
                        the information described in paragraph (1)(A) 
                        the Secretary shall transmit to the responsible 
                        person involved a notice stating that such 
                        responsible person shall submit such 
                        information by the date determined by the 
                        Secretary in consultation with such responsible 
                        person.
                            ``(ii) Failure to comply.--If, by the date 
                        specified by the Secretary in the notice under 
                        clause (i), the Secretary has not received the 
                        information described in paragraph (1)(A), the 
                        Secretary shall--
                                    ``(I) transmit to the responsible 
                                person involved a notice specifying the 
                                information required to be submitted to 
                                the Secretary and stating that such 
                                responsible person shall be liable for 
                                the civil monetary penalties described 
                                in subparagraph (D) if such information 
                                is not submitted to the Secretary 
                                within 30 days of the date on which 
                                such notice is transmitted; and
                                    ``(II) include and prominently 
                                display, until such time as the 
                                Secretary receives the information 
                                described in paragraph (1)(A), as part 
                                of the record of such trial in the 
                                database described in subsection (j), a 
                                notice stating that the results of such 
                                trials have not been reported as 
                                required by law.
                    ``(D) Noncompliance.--
                            ``(i) In general.--If by the date that is 
                        30 days after the date on which a notice 
                        described in subparagraph (C)(ii)(I) is 
                        transmitted, the Secretary has not received 
                        from the responsible person involved the 
                        information required pursuant to such notice, 
                        the Secretary, after providing the opportunity 
                        for a hearing, order such responsible person to 
                        pay a civil penalty of $10,000 for each day 
                        after such date that the information is not 
                        submitted.
                            ``(ii) Waivers.--In any case in which a 
                        responsible person described in clause (i) is a 
                        nonprofit entity, the Secretary may waive or 
                        reduce the penalties applicable under such 
                        clause to such person.
                    ``(E) Notice of publication of data.--If the 
                responsible person is the manufacturer or distributor 
                of the drug, biological product, or device involved, 
                the notice under subparagraphs (A)(i) and (C)(ii)(I) 
                shall include a notice that the Secretary shall publish 
                the data described in subsection (j)(3)(B) in the 
                database if the responsible person has not submitted 
                the information specified in the notice transmitted by 
                the date that is 6 months after the date of such 
                notice.
                    ``(F) Publication of data.--Notwithstanding section 
                301(j) of the Federal Food, Drug, and Cosmetic Act, 
                section 1905 of title 18, United States Code, or any 
                other provision of law, if the responsible person is 
                the manufacturer or distributor of the drug, 
biological product, or device involved, and if the responsible person 
has not submitted to the Secretary the information specified in a 
notice transmitted pursuant to subparagraph (A)(i) or (C)(ii)(I) by the 
date that is 6 months after the date of such notice, the Secretary 
shall publish in the registry information that--
                            ``(i) is described in subsection (j)(3)(B); 
                        and
                            ``(ii) the responsible person has submitted 
                        to the Secretary in any application, including 
a supplemental application, for the drug or device under section 505, 
510, 515, or 520 of the Federal Food, Drug, and Cosmetic Act or for the 
biological product under section 351.
            ``(3) Date specified.--The date specified in this paragraph 
        shall be the date that is 1 year from the earlier of--
                    ``(A) the estimated completion date of the trial, 
                submitted under subsection (j)(3)(B)(vi)(I)(hh); or
                    ``(B) the actual date of completion or termination 
                of the trial.
            ``(4) Use of funds.--
                    ``(A) In general.--The Secretary shall deposit the 
                funds collected under paragraph (2) into an account and 
                use such funds, in consultation with the Director of 
                the Agency for Healthcare Research and Quality, to fund 
                studies that compare the clinical effectiveness of 2 or 
                more treatments for a disease or condition.
                    ``(B) Funding decisions.--The Secretary shall award 
                funding under subparagraph (A) based on a priority list 
                established not later than 6 months after the date of 
                enactment of the FACT Act by the Director of the Agency 
                for Healthcare Research and Quality and periodically 
                updated as determined appropriate by the Director.
            ``(5) Inclusion in registry.--
                    ``(A) General rule.--The Secretary shall, pursuant 
                to subsection (j)(5), include--
                            ``(i) the data described in subsection 
                        (j)(3)(A) and submitted under the amendments 
                        made by section 4(a) of the FACT Act in the 
                        registry described in subsection (j) as soon as 
                        practicable after receiving such data; and
                            ``(ii) the data described in clause (I) of 
                        subsection (j)(3)(B)(iv) and submitted under 
                        this subsection in the database described in 
                        subsection (j) as soon as practicable after 
                        receiving such data.
                    ``(B) Other data.--
                            ``(i) In general.--The Secretary shall, 
                        pursuant to subsection (j)(5), include the data 
                        described in subclauses (II) through (X) of 
                        subsection (j)(3)(B)(iv) and submitted under 
                        this section in the database described in 
                        subsection (j)--
                                    ``(I) as soon as practicable after 
                                receiving such data; or
                                    ``(II) in the case of data to which 
                                clause (ii) applies, by the date 
                                described in clause (iii).
                            ``(ii) Data described.--This clause applies 
                        to data described in clause (i) if--
                                    ``(I) the responsible person 
                                involved requests a delay in the 
                                inclusion in the database of such data 
                                in order to have such data published in 
                                a peer reviewed journal; and
                                    ``(II) the Secretary determines 
                                that an attempt will be made to seek 
                                such publication.
                            ``(iii) Date for inclusion in registry.--
                        Subject to clause (iv), the date described in 
                        this clause is the earlier of--
                                    ``(I) the date on which the data 
                                involved is published as provided for 
                                in clause (ii); or
                                    ``(II) the date that is 18 months 
                                after the date on which such data is 
                                submitted to the Secretary.
                            ``(iv) Extension of date.--The Secretary 
                        may extend the 18-month period described in 
                        clause (iii)(II) for an additional 6 months if 
                        the responsible person demonstrates to the 
                        Secretary, prior to the expiration of such 18-
                        month period, that the data involved has been 
                        accepted for publication by a journal described 
                        in clause (ii)(I).
                            ``(v) Modification of data.--Prior to 
                        including data in the database under clause 
                        (ii) or (iv), the Secretary shall permit the 
                        responsible person to modify the data involved.
            ``(6) Effect.--The information with respect to a clinical 
        trial submitted to the Secretary under this subsection, 
        including data published by the Secretary pursuant to paragraph 
        (2)(F), may not be submitted by a person other than the 
        responsible person as part of, or referred to in, an 
application for approval of a drug or device under section 505, 510, 
515, or 520 of the Federal Food, Drug, and Cosmetic Act or of a 
biological product under section 351, unless the information is 
available from a source other than the registry or database described 
in subsection (j).
    ``(m) Procedures and Waivers.--
            ``(1) Submission prior to notice.--Nothing in subsections 
        (k) through (l) shall be construed to prevent a principal 
        investigator or a responsible person from submitting any 
        information required under this subsection to the Secretary 
        prior to receiving any notice described in such subsections.
            ``(2) Ongoing trials.--A factually accurate statement that 
        a clinical trial is ongoing shall be deemed to be information 
        sufficient to demonstrate to the Secretary that the information 
        described in subsections (k)(1)(A) and (l)(1)(A) cannot 
        reasonably be submitted.
            ``(3) Information previously submitted.--Nothing in 
        subsections (k) through (l) shall be construed to require the 
        Secretary to send a notice to any principal investigator or 
        responsible person requiring the submission to the Secretary of 
        information that has already been submitted.
            ``(4) Submission format and technical standards.--
                    ``(A) In general.--The Secretary shall, to the 
                extent practicable, accept submissions required under 
                this subsection in an electronic format and shall 
                establish interoperable technical standards for such 
                submissions.
                    ``(B) Consistency of standards.--To the extent 
                practicable, the standards established under 
                subparagraph (A) shall be consistent with standards 
                adopted by the Consolidated Health Informatics 
                Initiative (or a successor organization to such 
                Initiative) to the extent such Initiative (or 
                successor) is in operation.
            ``(5) Trials completed prior to enactment.--The Secretary 
        shall establish procedures and mechanisms to allow for the 
        voluntary submission to the database of the information 
        described in subsection (j)(3)(B) with respect to clinical 
        trials completed prior to the date of enactment of the FACT 
        Act. In cases in which it is in the interest of public health, 
        the Secretary may require that information from such trials be 
        submitted to the database. Failure to comply with such a 
        requirement shall be deemed to be a failure to submit 
        information as required under this section, and the appropriate 
        remedies and sanctions under this section shall apply.
            ``(6) Trials not involving drugs, biological products, or 
        devices.--The Secretary shall establish procedures and 
        mechanisms to allow for the voluntary submission to the 
        database of the information described in subsection (j)(3)(B) 
        with respect to clinical trials that do not involve drugs, 
        biological products, or devices. In cases in which it is in the 
        interest of public health, the Secretary may require that 
        information from such trials be submitted to the database. 
        Failure to comply with such a requirement shall be deemed to be 
        a failure to submit information as required under this section, 
        and the appropriate remedies and sanctions under this section 
        shall apply.
            ``(7) Submission of inaccurate information.--
                    ``(A) In general.--If the Secretary determines that 
                information submitted by a principal investigator or a 
                responsible person under this section is factually and 
                substantively inaccurate, the Secretary shall submit a 
                notice to the investigator or responsible person 
                concerning such inaccuracy that includes--
                            ``(i) a summary of the inaccuracies 
                        involved; and
                            ``(ii) a request for corrected information 
                        within 30 days.
                    ``(B) Audit of information.--
                            ``(i) In general.--The Secretary may 
                        conduct audits of any information submitted 
                        under subsection (j).
                            ``(ii) Requirement.--Any principal 
                        investigator or responsible person that has 
                        submitted information under subsection (j) 
                        shall permit the Secretary to conduct the audit 
                        described in clause (i).
                    ``(C) Changes to information.--Any change in the 
                information submitted by a principal investigator or a 
                responsible person under this section shall be reported 
                to the Secretary within 30 days of the date on which 
                such investigator or person became aware of the change 
                for purposes of updating the registry or the database.
                    ``(D) Failure to correct.--If a principal 
                investigator or a responsible person fails to permit an 
audit under subparagraph (B), provide corrected information pursuant to 
a notice under subparagraph (A), or provide changed information under 
subparagraph (C), the investigator or responsible person involved shall 
be deemed to have failed to submit information as required under this 
section and the appropriate remedies and sanction under this section 
shall apply.
                    ``(E) Corrections.--
                            ``(i) In general.--The Secretary may 
                        correct, through any means deemed appropriate 
                        by the Secretary to protect public health, any 
                        information included in the registry or the 
                        database described in subsection (j) (including 
                        information described or contained in a 
                        publication referred to under subclause (VI) of 
                        subsection (j)(3)(B)(iv)) that is--
                                    ``(I) submitted to the Secretary 
                                for inclusion in the registry or the 
                                database; and
                                    ``(II) factually and substantively 
                                inaccurate or false or misleading.
                            ``(ii) Reliance on information.--The 
                        Secretary may rely on any information from a 
                        clinical trial or a report of an adverse event 
                        acquired or produced under the authority of 
                        section 351 of this Act or of the Federal Food, 
                        Drug, and Cosmetic Act in determining whether 
                        to make corrections as provided for in clause 
                        (i).
                            ``(iii) Determinations relating to 
                        misleading information.--For purposes of clause 
                        (i)(II), in determining whether information is 
                        misleading, the Secretary shall use the 
                        standard described in section 201(n) of the 
                        Federal Food, Drug, and Cosmetic Act that is 
                        used to determine whether labeling or 
                        advertising is misleading.
                            ``(iv) Rule of construction.--This 
                        subparagraph shall not be construed to 
                        authorize the disclosure of information if--
                                    ``(I) such disclosure would 
                                constitute an invasion of personal 
                                privacy;
                                    ``(II) such information concerns a 
                                method or process which as a trade 
                                secret is entitled to protection within 
                                the meaning of section 301(j) of the 
                                Federal Food, Drug, and Cosmetic Act;
                                    ``(III) such disclosure would 
                                disclose confidential commercial 
                                information or a trade secret, other 
                                than a trade secret described in 
                                subclause (II), unless such disclosure 
                                is necessary--
                                            ``(aa) to make a correction 
                                        as provided for under clause 
                                        (i); and
                                            ``(bb) protect the public 
                                        health; or
                                    ``(IV) if such disclosure relates 
                                to a biological product for which no 
                                license is in effect under section 351, 
                                a drug for which no approved 
                                application is in effect under section 
                                505(c) of the Federal Food, Drug, and 
                                Cosmetic Act, or a device that is not 
                                cleared under section 510(k) of such 
                                Act or for which no application is in 
                                effect under section 515 of such Act.
                            ``(v) Notice.--In the case of a disclosure 
                        under clause (iv)(III), the Secretary shall 
                        notify the manufacturer or distributor of the 
                        drug, biological product, or device involved--
                                    ``(I) at least 30 days prior to 
                                such disclosure; or
                                    ``(II) if immediate disclosure is 
                                necessary to protect the public health, 
                                concurrently with such disclosure.
            ``(8) Waivers regarding clinical trial results.--The 
        Secretary may waive the requirements of subsections (k)(1) and 
        (l)(1) that the results of clinical trials be submitted to the 
        Secretary, upon a written request from the responsible person 
        if the Secretary determines that extraordinary circumstances 
        justify the waiver and that providing the waiver is in the 
        public interest or consistent with the protection of public 
        health.
    ``(n) Trials Conducted Outside of the United States.--
            ``(1) In general.--With respect to clinical trials 
        described in paragraph (2), the responsible person shall submit 
        to the Secretary the information required under subclauses (II) 
        through (X) of subsection (j)(3)(B)(iv). Failure to comply with 
        this paragraph shall be deemed to be a failure to submit 
        information as required under this section, and the appropriate 
        remedies and sanctions under this section shall apply.
            ``(2) Clinical trial described.--A clinical trial is 
        described in this paragraph if--
                    ``(A) such trial is conducted outside of the United 
                States; and
                    ``(B) the data from such trial is--
                            ``(i) submitted to the Secretary as part of 
                        an application, including a supplemental 
                        application, for a drug or device under section 
                        505, 510, 515, or 520 of the Federal Food, 
                        Drug, and Cosmetic Act or for the biological 
                        product under section 351; or
                            ``(ii) used in advertising or labeling to 
                        make a claim about the drug, device, or 
                        biological product involved.
    ``(o) Definitions; Individual Liability.--
            ``(1) Responsible person.--
                    ``(A) In general.--In this section, the term 
                `responsible person' with respect to a clinical trial, 
                means--
                            ``(i) if such clinical trial is the subject 
                        of an investigational new drug application or 
                        an application for an investigational device 
                        exemption, the sponsor of such investigational 
                        new drug application or such application for an 
                        investigational device exemption; or
                            ``(ii) except as provided in subparagraph 
                        (B), if such clinical trial is not the subject 
                        of an investigational new drug application or 
                        an application for an investigational device 
                        exemption--
                                    ``(I) the person that provides the 
                                largest share of the monetary support 
                                (such term does not include in-kind 
                                support) for the conduct of such trial; 
                                or
                                    ``(II) in the case in which the 
                                person described in subclause (I) is a 
                                Federal or State agency, the principal 
                                investigator of such trial.
                    ``(B) Nonprofit entities and requesting persons.--
                            ``(i) Nonprofit entities.--For purposes of 
                        subparagraph (A)(ii)(I), if the person that 
                        provides the largest share of the monetary 
                        support for the conduct of the clinical trial 
                        involved is a nonprofit entity, the responsible 
                        person for purposes of this section shall be--
                                    ``(I) the nonprofit entity; or
                                    ``(II) if the nonprofit entity and 
                                the principal investigator of such 
                                trial jointly certify to the Secretary 
                                that the principal investigator will be 
                                responsible for submitting the 
                                information described in subsection 
                                (j)(3)(B) for such trial, the principal 
                                investigator.
                            ``(ii) Requesting persons.--For purposes of 
                        subparagraph (A)(ii)(I), if a person--
                                    ``(I) has submitted a request to 
                                the Secretary that the Secretary 
                                recognize the person as the responsible 
                                person for purposes of this section; 
                                and
                                    ``(II) the Secretary determines 
                                that such person--
                                            ``(aa) provides monetary 
                                        support for the conduct of such 
                                        trial;
                                            ``(bb) is responsible for 
                                        the conduct of such trial; and
                                            ``(cc) will be responsible 
                                        for submitting the information 
                                        described in subsection 
                                        (j)(3)(B) for such trial;
                        such person shall be the responsible person for 
                        purposes of this section.
            ``(2) Drug, device, biological product.--In this section--
                    ``(A) the terms `drug' and `device' have the 
                meanings given such terms in section 201 of the Federal 
                Food, Drug, and Cosmetic Act; and
                    ``(B) the term `biological product' has the meaning 
                given such term in section 351 of this Act.
            ``(3) Individual liability.--
                    ``(A) Limitation on liability of individuals.--No 
                individual shall be liable for any civil monetary 
                penalty under this section.
                    ``(B) Individuals who are responsible persons.--If 
                a responsible person under subparagraph (A) or (B) of 
paragraph (1) is an individual, such individual shall be subject to the 
procedures and conditions described in subsection (k).''.
    (c) Authorization of Appropriations.--Section 402 of the Public 
Health Service Act (42 U.S.C. 282), as amended by this section, is 
further amended by adding at the end the following:
    ``(s) Authorization of Appropriations.--There are authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

SEC. 4. REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH.

    (a) Amendments.--Section 492A(a) of the Public Health Service Act 
(42 U.S.C. 289a-1(a)) is amended--
            (1) in paragraph (1)(A), by striking ``unless'' and all 
        that follows through the period and inserting the following: 
        ``unless--
                            ``(i) the application has undergone review 
                        in accordance with such section and has been 
                        recommended for approval by a majority of the 
                        members of the Board conducting the review;
                            ``(ii) such Board has submitted to the 
                        Secretary a notification of such approval; and
                            ``(iii) with respect to an application 
                        involving a clinical trial to which section 
                        402(j) applies, the principal investigator who 
                        has submitted such application has submitted to 
                        the Secretary for inclusion in the registry and 
                        the database described in section 402(j) the 
                        information described in paragraph (3)(A) and 
                        subclause (I) of paragraph (3)(B)(iv) of such 
                        section.''; and
            (2) by adding at the end the following:
            ``(3) Cost recovery.--Nonprofit entities may recover the 
        full costs associated with compliance with the requirements of 
        paragraph (1) from the Secretary as a direct cost of 
        research.''.
    (b) Regulations.--The Secretary of Health and Human Services shall 
modify the regulations promulgated at part 46 of title 45, Code of 
Federal Regulations, part 50 of title 21, Code of Federal Regulations, 
and part 56 of title 21, Code of Federal Regulations, to reflect the 
amendments made by subsection (a).

SEC. 5. PROHIBITED ACTS.

    Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended by adding at the end the following:
    ``(hh)(1) The entering into of a contract or other agreement by a 
responsible person or a manufacturer of a drug, biological product, or 
device with an individual who is not an employee of such responsible 
person or manufacturer, or the performance of any other act by such a 
responsible person or manufacturer, that prohibits, limits, or imposes 
unreasonable delays on the ability of such individual to--
            ``(A) discuss the results of a clinical trial at a 
        scientific meeting or any other public or private forum; or
            ``(B) publish the results of a clinical trial or a 
        description or discussion of the results of a clinical trial in 
        a scientific journal or any other publication.
    ``(2) The entering into a contract or other agreement by a 
responsible person or a manufacturer of a drug, biological product, or 
device with an academic institution or a health care facility, or the 
performance of any other act by such a responsible person or 
manufacturer, that prohibits, limits, or imposes unreasonable delays on 
the ability of an individual who is not an employee of such responsible 
person or manufacturer to--
            ``(A) discuss the results of a clinical trial at a 
        scientific meeting or any other public or private forum; or
            ``(B) publish the results of a clinical trial or a 
        description or discussion of the results of a clinical trial in 
        a scientific journal or any other publication.''.

SEC. 6. REPORTS.

    (a) Implementation Report.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the appropriate committees of Congress a report on the status 
of the implementation of the requirements of the amendments made by 
section 3 that includes a description of the number and types of 
clinical trials for which information has been submitted under such 
amendments.
    (b) Data Collection.--
            (1) In general.--The Secretary of Health and Human Services 
        shall enter into a contract with the Institute of Medicine for 
        the conduct of a study concerning the extent to which data 
        submitted to the registry under section 402(j) of the Public 
        Health Service Act (42 U.S.C. 282(j)) has impacted the public 
        health.
            (2) Report.--Not later than 6 months after the date on 
        which a contract is entered into under paragraph (1), the 
        Institute of Medicine shall submit to the Secretary of Health 
        and Human Services a report on the results of the study 
        conducted under such paragraph. Such report shall include 
        recommendations for changes to the registry, the database, and 
        the data submission requirements that would benefit the public 
        health.
                                 <all>
```