II 

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Fair Access to Clinical 

5 Trials Act of 2005’’ or the ‘‘FACT Act’’. 

6 SEC. 2. PURPOSE. 

7 It is the purpose of this Act—

8 (1) to create a publicly accessible national data 

9 bank of clinical trial information comprised of a clin-
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1 ical trial registry and a clinical trial results data2 base; 

3 (2) to foster transparency and accountability in 

4 health-related intervention research and develop5 ment; 

6 (3) to maintain a clinical trial registry acces7 sible to patients and health care practitioners seek8 ing information related to ongoing clinical trials for 

9 serious or life-threatening diseases and conditions; 

10 and 

11 (4) to establish a clinical trials results database 

12 of all publicly and privately funded clinical trial re13 sults regardless of outcome, that is accessible to the 

14 scientific community, health care practitioners, and 

15 members of the public. 

16 SEC. 3. CLINICAL TRIALS DATA BANK. 

17 (a) IN GENERAL.—Section 402(j) of the Public 

18 Health Service Act (42 U.S.C. 282(j)) is amended—

19 (1) in paragraph (1)(A), by striking ‘‘for drugs 

20 for serious or life-threatening diseases and condi21 tions’’; 

22 (2) in paragraph (2), by striking ‘‘available to 

23 individuals with serious’’ and all that follows 

24 through the period and inserting ‘‘accessible to pa25 tients, other members of the public, health care 
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1 practitioners, researchers and the scientific commu2 nity. In making information about clinical trials pub3 licly available, the Secretary shall seek to be as time4 ly and transparent as possible.’’; 

5 (3) by redesignating paragraphs (4) and (5), as 

6 paragraphs (8) and (9), respectively; 

7 (4) by striking paragraph (3) and inserting the 

8 following: 

9 ‘‘(3) The data bank shall include the following: 

10 ‘‘(A)(i) A registry of clinical trials (in this sub11 paragraph referred to as the ‘registry’) of health-re12 lated interventions (whether federally or privately 

13 funded). 

14 ‘‘(ii) The registry shall include information for 

15 all clinical trials conducted to test the safety or ef16 fectiveness (including comparative effectiveness) of 

17 any drug, biological product, or device (including 

18 those drugs, biological products, or devices approved 

19 or cleared by the Secretary) intended to treat serious 

20 or life-threatening diseases and conditions, except 

21 those Phase I clinical trials conducted to test solely 

22 the safety of an unapproved drug or unlicensed bio23 logical product, or pilot or feasibility studies con24 ducted to confirm the design and operating speci25 fications of an unapproved or not yet cleared med-
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1 ical device. For purposes of this section, Phase I 

2 clinical trials are trials described in section 

3 313.12(a) of title 21, Code of Federal Regulations 

4 (or any successor regulations). 

5 ‘‘(iii) The registry may include information 

6 for—

7 ‘‘(I) Phase I clinical trials conducted to 

8 test solely the safety of an unapproved drug or 

9 unlicensed biological product, or pilot or feasi10 bility studies conducted to confirm the design 

11 and operating specifications of an unapproved 

12 or not yet cleared medical device with the con13 sent of the responsible person; and 

14 ‘‘(II) clinical trials of other health-related 

15 interventions with the consent of the responsible 

16 person. 

17 ‘‘(iv) The information to be included in the reg18 istry under this subparagraph shall include the fol19 lowing: 

20 ‘‘(I) Descriptive information, including a 

21 brief title, trial description in lay terminology, 

22 trial phase, trial type, trial purpose, description 

23 of the primary and secondary clinical outcome 

24 measures to be examined in the trial, the time 

25 at which the outcome measures will be assessed, 
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1 and the dates and details of any revisions to 

2 such outcomes. 

3 ‘‘(II) Recruitment information, including 

4 eligibility and exclusion criteria, a description of 

5 whether, and through what procedure, the man6 ufacturer or sponsor of the investigation of a 

7 new drug will respond to requests for protocol 

8 exception, with appropriate safeguards, for sin9 gle-patient and expanded protocol use of the 

10 new drug, particularly in children, a statement 

11 as to whether the trial is closed to enrollment 

12 of new patients, overall trial status, individual 

13 site status, and estimated completion date. For 

14 purposes of this section the term ‘completion 

15 date’ means the date of the last visit by sub16 jects in the trial for the outcomes described in 

17 subclause (I). 

18 ‘‘(III) Location and contact information, 

19 including the identity of the responsible person. 

20 ‘‘(IV) Administrative data, including the 

21 study sponsor and the study funding source. 

22 ‘‘(V) Information pertaining to experi23 mental treatments for serious or life threat24 ening diseases and conditions (whether federally 

25 or privately funded) that may be available—
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1 ‘‘(aa) under a treatment investiga2 tional new drug application that has been

3 submitted to the Secretary under section 

4 360bbb(c) of title 21, Code of Federal 

5 Regulations; or 

6 ‘‘(bb) as a Group C cancer drug (as 

7 defined by the National Cancer Institute). 

8 ‘‘(B)(i) A clinical trials results database (in this 

9 subparagraph referred to as the ‘database’) of 

10 health-related interventions (whether federally or 

11 privately funded). 

12 ‘‘(ii) The database shall include information for 

13 all clinical trials conducted to test the safety or ef14 fectiveness (including comparative effectiveness) of 

15 any drug, biological product, or device (including 

16 those drugs, biological products, or devices approved 

17 or cleared by the Secretary), except those Phase I 

18 clinical trials conducted to test solely the safety of 

19 an unapproved drug or unlicensed biological product, 

20 or pilot or feasibility studies conducted to confirm 

21 the design and operating specifications of an unap22 proved or not yet cleared medical device. 

23 ‘‘(iii) The database may include information 

24 for—
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1 ‘‘(I) Phase I clinical trials conducted to 

2 test solely the safety of an unapproved drug or 

3 unlicensed biological product, or pilot or feasi4 bility studies conducted to confirm the design 

5 and operating specifications of an unapproved 

6 or not yet cleared medical device with the con7 sent of the responsible person; and 

8 ‘‘(II) clinical trials of other health-related 

9 interventions with the consent of the responsible 

10 person. 

11 ‘‘(iv) The information to be included in the 

12 database under this subparagraph shall include the 

13 following: 

14 ‘‘(I) Descriptive information, including—

15 ‘‘(aa) a brief title; 

16 ‘‘(bb) the drug, biological product or 

17 device to be tested; 

18 ‘‘(cc) a trial description in lay termi19 nology; 

20 ‘‘(dd) the trial phase; 

21 ‘‘(ee) the trial type; 

22 ‘‘(ff) the trial purpose; 

23 ‘‘(gg) the estimated completion date 

24 for the trial; and 
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1 ‘‘(hh) the study sponsor and the study 

2 funding source. 

3 ‘‘(II) A description of the primary and sec4 ondary clinical outcome measures to be exam5 ined in the trial, the time at which the outcome 

6 measures will be assessed, and the dates and 

7 details of any revisions to such outcomes. 

8 ‘‘(III) The actual completion date of the 

9 trial and the reasons for any difference from 

10 such actual date and the estimated completion 

11 date submitted pursuant to subclause (I)(hh). 

12 If the trial is not completed, the termination 

13 date and reasons for such termination. 

14 ‘‘(IV) A summary of the results of the trial 

15 in a standard, non-promotional summary for16 mat (such as ICHE3 template form), including 

17 the trial design and methodology, results of the 

18 primary and secondary outcome measures as 

19 described in subclause (II), summary data ta20 bles with respect to the primary and secondary 

21 outcome measures, including information on the 

22 statistical significance or lack thereof of such 

23 results. 

24 ‘‘(V) Safety data concerning the trial (in25 cluding a summary of all adverse events speci-
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1 fying the number and type of such events, data 

2 on prespecified adverse events, data on serious 

3 adverse events, and data on overall deaths). 

4 ‘‘(VI) Any publications in peer reviewed 

5 journals relating to the trial. If the trial results 

6 are published in a peer reviewed journal, the 

7 database shall include a citation to and, when 

8 available, a link to the journal article. 

9 ‘‘(VII) A description of the process used to 

10 review the results of the trial, including a state11 ment about whether the results have been peer 

12 reviewed by reviewers independent of the trial 

13 sponsor. 

14 ‘‘(VIII) If the trial addresses the safety, 

15 effectiveness, or benefit of a use not described 

16 in the approved labeling for the drug, biological 

17 product, or device, a statement, as appropriate, 

18 displayed prominently at the beginning of the 

19 data in the registry with respect to the trial, 

20 that the Food and Drug Administration—

21 ‘‘(aa) is currently reviewing an appli22 cation for approval of such use to deter23 mine whether the use is safe and effective; 

24 ‘‘(bb) has disapproved an application 

25 for approval of such use; 
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1 ‘‘(cc) has reviewed an application for 

2 approval of such use but the application 

3 was withdrawn prior to approval or dis4 approval; or 

5 ‘‘(dd) has not reviewed or approved 

6 such use as safe and effective. 

7 ‘‘(IX) If data from the trial has not been 

8 submitted to the Food and Drug Administra9 tion, an explanation of why it has not been sub10 mitted. 

11 ‘‘(X) A description of the protocol used in 

12 such trial to the extent necessary to evaluate 

13 the results of such trial. 

14 ‘‘(4)(A) Not later than 90 days after the date of the 

15 completion of the review by the Food and Drug Adminis16 tration of information submitted by a sponsor in support 

17 of a new drug application, or a supplemental new drug 

18 application, whether or not approved by the Food and 

19 Drug Administration, the Commissioner of Food and 

20 Drugs shall make available to the public the full reviews 

21 conducted by the Administration of such application. 

22 ‘‘(B) Not later than 90 days after the date of the 

23 completion of a written consultation on a drug concerning 

24 the drug’s safety conducted by the Office of Drug Safety, 

25 regardless of whether initiated by such Office or outside 
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1 of the Office, the Commissioner of Food and Drugs shall

2 make available to the public a copy of such consultation 

3 in full. 

4 ‘‘(C) Nothing in this paragraph shall be construed to 

5 alter or amend section 301(j) or section 1905 of title 18, 

6 United States Code. 

7 ‘‘(D) This paragraph shall supersede section 552 of 

8 title 5, United States Code. 

9 ‘‘(5) The information described in subparagraphs (A) 

10 and (B) of paragraph (3) shall be in a format that can 

11 be readily accessed and understood by members of the 

12 general public, including patients seeking to enroll as sub13 jects in clinical trials. 

14 ‘‘(6) The Secretary shall assign each clinical trial a 

15 unique identifier to be included in the registry and in the 

16 database described in subparagraphs (A) and (B) of para17 graph (3). To the extent practicable, this identifier shall 

18 be consistent with other internationally recognized and 

19 used identifiers. 

20 ‘‘(7) To the extent practicable, the Secretary shall en21 sure that where the same information is required for the 

22 registry and the database described in subparagraphs (A) 

23 and (B) of paragraph (3), a process exists to allow the 

24 responsible person to make only one submission.’’; and 

25 (5) by adding at the end the following: 
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1 ‘‘(10) In this section, the term ‘clinical trial’ with re2 spect to the registry and the database described in sub3 paragraphs (A) and (B) of paragraph (3) means a re4 search study in human volunteers to answer specific health 

5 questions, including treatment trials, prevention trials, di6 agnostic trials, screening trials, and quality of life trials.’’. 

7 (b) ACTIONS OF SECRETARY REGARDING CLINICAL

8 TRIALS.—Section 402 of the Public Health Service Act 

9 (42 U.S.C. 282) is amended—

10 (1) by redesignating subsections (k) and (l) as 

11 subsections (q) and (r), respectively; and 

12 (2) by inserting after subsection (j), the fol13 lowing: 

14 ‘‘(k) FEDERALLY SUPPORTED TRIALS.—

15 ‘‘(1) ALL FEDERALLY SUPPORTED TRIALS.—

16 With respect to any clinical trial described in sub17 section (j)(3)(B) that is supported solely by a grant, 

18 contract, or cooperative agreement awarded by the 

19 Secretary, the principal investigator of such trial 

20 shall, not later than the date specified in paragraph 

21 (2), submit to the Secretary—

22 ‘‘(A) the information described in sub23 clauses (II) through (X) of subsection 

24 (j)(3)(B)(iv), and with respect to clinical trials 

25 in progress on the date of enactment of the 
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1 FACT Act, the information described in sub2 clause (I) of subsection (j)(3)(B)(iv); or 

3 ‘‘(B) a statement containing information 

4 sufficient to demonstrate to the Secretary that 

5 the information described in subparagraph (A) 

6 cannot reasonably be submitted, along with an 

7 estimated date of submission of the information 

8 described in such subparagraph. 

9 ‘‘(2) DATE SPECIFIED.—The date specified in 

10 this paragraph shall be the date that is 1 year from 

11 the earlier of—

12 ‘‘(A) the estimated completion date of the 

13 trial, as submitted under subsection 

14 (j)(3)(B)(vi)(I)(hh); or 

15 ‘‘(B) the actual date of the completion or 

16 termination of the trial. 

17 ‘‘(3) CONDITION OF FEDERAL GRANTS, CON18 TRACTS, AND COOPERATIVE AGREEMENTS.—

19 ‘‘(A) CERTIFICATION OF COMPLIANCE.—

20 To be eligible to receive a grant, contract, or 

21 cooperative agreement from the Secretary for 

22 the conduct or support of a clinical trial de23 scribed in subsection (j)(3)(B), the principal in24 vestigator involved shall certify to the Secretary 

25 that—
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1 ‘‘(i) such investigator shall submit 

2 data to the Secretary in accordance with 

3 this subsection; and 

4 ‘‘(ii) such investigator has complied 

5 with the requirements of this subsection 

6 with respect to other clinical trials con7 ducted by such investigator after the date 

8 of enactment of the FACT Act. 

9 ‘‘(B) FAILURE TO SUBMIT CERTIFI10 CATION.—An investigator that fails to submit a 

11 certification as required under subparagraph 

12 (A) shall not be eligible to receive a grant, con13 tract, or cooperative agreement from the Sec14 retary for the conduct or support of a clinical 

15 trial described in subsection (j)(3)(B). 

16 ‘‘(C) FAILURE TO COMPLY WITH CERTIFI17 CATION.—If, by the date specified in paragraph 

18 (2), the Secretary has not received the informa19 tion or statement described in paragraph (1), 

20 the Secretary shall—

21 ‘‘(i) transmit to the principal investi22 gator involved a notice specifying the infor23 mation or statement required to be sub24 mitted to the Secretary and stating that 

25 such investigator shall not be eligible to re-
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1 ceive further funding from the Secretary if 

2 such information or statement is not sub3 mitted to the Secretary within 30 days of 

4 the date on which such notice is trans5 mitted; and 

6 ‘‘(ii) include and prominently display, 

7 until such time as the Secretary receives 

8 the information or statement described in 

9 paragraph (1), as part of the record of 

10 such trial in the database described in sub11 section (j), a notice stating that the results 

12 of such trials have not been reported as re13 quired by law. 

14 ‘‘(D) FAILURE TO COMPLY WITH NO15 TICE.—If by the date that is 30 days after the 

16 date on which the notice described in subpara17 graph (C) is transmitted, the Secretary has not 

18 received from the principal investigator involved 

19 the information or statement required pursuant 

20 to such notice, the Secretary may not award a 

21 grant, contract, cooperative agreement, or any 

22 other award to such principal investigator until 

23 such principal investigator submits to the Sec24 retary the information or statement required 

25 pursuant to such notice.
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1 ‘‘(E) SUBMISSION OF STATEMENT BUT

2 NOT INFORMATION.—

3 ‘‘(i) IN GENERAL.—If by the date 

4 specified in paragraph (2), the Secretary 

5 has received a statement described in para6 graph (1)(B) but not the information de7 scribed in paragraph (1)(A), the Secretary 

8 shall transmit to the principal investigator 

9 involved a notice stating that such investi10 gator shall submit such information by the 

11 date determined by the Secretary in con12 sultation with such investigator. 

13 ‘‘(ii) FAILURE TO COMPLY WITH CER14 TIFICATION.—If, by the date specified by 

15 the Secretary in the notice under clause 

16 (i), the Secretary has not received the in17 formation described in paragraph (1)(B), 

18 the Secretary shall—

19 ‘‘(I) transmit to the principal in20 vestigator involved a notice specifying 

21 the information required to be sub22 mitted to the Secretary and stating 

23 that such investigator shall not be eli24 gible to receive further funding from 

25 the Secretary if such information is 
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1 not submitted to the Secretary within 

2 30 days of the date on which such no3 tice is transmitted; and 

4 ‘‘(II) include and prominently 

5 display, until such time as the Sec6 retary receives the information de7 scribed in paragraph (1)(B), as part 

8 of the record of such trial in the data9 base described in subsection (j), a no10 tice stating that the results of such 

11 trials have not been reported as re12 quired by law. 

13 ‘‘(F) FAILURE TO COMPLY WITH NO14 TICE.—If by the date that is 30 days after the 

15 date on which the notice described in subpara16 graph (E)(ii)(I) is transmitted, the Secretary 

17 has not received from the principal investigator 

18 involved the information required pursuant to 

19 such notice, the Secretary may not award a 

20 grant, contract, cooperative agreement, or any 

21 other award to such principal investigator until 

22 such principal investigator submits to the Sec23 retary the information required pursuant to 

24 such notice. 
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1 ‘‘(G) RULE OF CONSTRUCTION.—For pur2 poses of this paragraph, limitations on the 

3 awarding of grants, contracts, cooperative 

4 agreements, or any other awards to principal 

5 investigators for violations of this paragraph 

6 shall not be construed to include any funding 

7 that supports the clinical trial involved. 

8 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

9 this subsection shall be construed to prevent an in10 vestigator other than the investigator described in

11 paragraph (3)(F) from receiving an ongoing award, 

12 contract, or cooperative agreement. 

13 ‘‘(5) INCLUSION IN REGISTRY.—

14 ‘‘(A) GENERAL RULE.—The Secretary 

15 shall, pursuant to subsection (j)(5), include—

16 ‘‘(i) the data described in subsection 

17 (j)(3)(A) and submitted under the amend18 ments made by section 4(a) of the FACT 

19 Act in the registry described in subsection 

20 (j) as soon as practicable after receiving 

21 such data; and 

22 ‘‘(ii) the data described in clause (I) 

23 of subsection (j)(3)(B)(iv) and submitted 

24 under this subsection or the amendments 

25 made by section 4(a) of the FACT Act in 
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1 the database described in subsection (j) as 

2 soon as practicable after receiving such 

3 data. 

4 ‘‘(B) OTHER DATA.—

5 ‘‘(i) IN GENERAL.—The Secretary 

6 shall, pursuant to subsection (j)(5), include 

7 the data described in subclauses (II) 

8 through (X) of subsection (j)(3)(B)(iv) and 

9 submitted under this section in the data10 base described in subsection (j)—

11 ‘‘(I) as soon as practicable after 

12 receiving such data; or 

13 ‘‘(II) in the case of data to which 

14 clause (ii) applies, by the date de15 scribed in clause (iii). 

16 ‘‘(ii) DATA DESCRIBED.—This clause 

17 applies to data described in clause (i) if—

18 ‘‘(I) the principal investigator in19 volved requests a delay in the inclu20 sion in the database of such data in 

21 order to have such data published in 

22 a peer reviewed journal; and 

23 ‘‘(II) the Secretary determines 

24 that an attempt will be made to seek 

25 such publication. 
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1 ‘‘(iii) DATE FOR INCLUSION IN REG2 ISTRY.—Subject to clause (iv), the date de3 scribed in this clause is the earlier of—

4 ‘‘(I) the date on which the data 

5 involved is published as provided for 

6 in clause (ii); or 

7 ‘‘(II) the date that is 18 months 

8 after the date on which such data is 

9 submitted to the Secretary. 

10 ‘‘(iv) EXTENSION OF DATE.—The 

11 Secretary may extend the 18-month period 

12 described in clause (iii)(II) for an addi13 tional 6 months if the principal investi14 gator demonstrates to the Secretary, prior 

15 to the expiration of such 18-month period, 

16 that the data involved has been accepted 

17 for publication by a journal described in 

18 clause (ii)(I). 

19 ‘‘(v) MODIFICATION OF DATA.—Prior 

20 to including data in the database under 

21 clause (ii) or (iv), the Secretary shall per22 mit the principal investigator to modify the 

23 data involved. 

24 ‘‘(6) MEMORANDUM OF UNDERSTANDING.—Not 

25 later than 6 months after the date of enactment of
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1 the FACT Act, the Secretary shall seek a memo2 randum of understanding with the heads of all other 

3 Federal agencies that conduct clinical trials to in4 clude in the registry and the database clinical trials 

5 sponsored by such agencies that meet the require6 ments of this subsection. 

7 ‘‘(7) APPLICATION TO CERTAIN PERSONS.—The 

8 provisions of this subsection shall apply to a respon9 sible person described in subsections (p)(1)(A)(ii)(II) 

10 or (p)(1)(B)(i)(II). 

11 ‘‘(l) TRIALS WITH NON-FEDERAL SUPPORT.—

12 ‘‘(1) IN GENERAL.—The responsible person for 

13 a clinical trial described in subsection (j)(3)(B) 

14 shall, not later than the date specified in paragraph 

15 (3), submit to the Secretary—

16 ‘‘(A) the information described in sub17 clauses (II) through (X) of subsection 

18 (j)(3)(B)(iv), and with respect to clinical trials 

19 in progress on the date of enactment of the 

20 FACT Act, the information described in sub21 clause (I) of subsection (j)(3)(B)(iv); or 

22 ‘‘(B) a statement containing information 

23 sufficient to demonstrate to the Secretary that 

24 the information described in subparagraph (A) 

25 cannot reasonably be submitted, along with an 
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1 estimated date of submission of the information 

2 described in such subparagraph. 

3 ‘‘(2) SANCTION IN CASE OF NONCOMPLIANCE.—

4 ‘‘(A) INITIAL NONCOMPLIANCE.—If by the 

5 date specified in paragraph (3), the Secretary 

6 has not received the information or statement 

7 required to be submitted to the Secretary under 

8 paragraph (1), the Secretary shall—

9 ‘‘(i) transmit to the responsible person 

10 for such trial a notice stating that such re11 sponsible person shall be liable for the civil 

12 monetary penalties described in subpara13 graph (B) if the required information or 

14 statement is not submitted to the Sec15 retary within 30 days of the date on which 

16 such notice is transmitted; and 

17 ‘‘(ii) include and prominently display, 

18 until such time as the Secretary receives 

19 the information described in paragraph 

20 (1), as part of the record of such trial in 

21 the database described in subsection (j), a 

22 notice stating that the results of such 

23 trials have not been reported as required 

24 by law. 
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1 ‘‘(B) CIVIL MONETARY PENALTIES FOR

2 NONCOMPLIANCE.—

3 ‘‘(i) IN GENERAL.—If by the date that 

4 is 30 days after the date on which a notice 

5 described in subparagraph (A) is trans6 mitted, the Secretary has not received from 

7 the responsible person involved the infor8 mation or statement required pursuant to 

9 such notice, the Secretary shall, after pro10 viding the opportunity for a hearing, order 

11 such responsible person to pay a civil pen12 alty of $10,000 for each day after such 

13 date that the information or statement is 

14 not submitted. 

15 ‘‘(ii) WAIVERS.—In any case in which 

16 a responsible person described in clause (i) 

17 is a nonprofit entity, the Secretary may 

18 waive or reduce the penalties applicable 

19 under such clause to such person. 

20 ‘‘(C) SUBMISSION OF STATEMENT BUT

21 NOT INFORMATION.—

22 ‘‘(i) IN GENERAL.—If by the date 

23 specified in paragraph (3), the Secretary 

24 has received a statement described in para25 graph (1)(B) but not the information de-
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1 scribed in paragraph (1)(A) the Secretary 

2 shall transmit to the responsible person in3 volved a notice stating that such respon4 sible person shall submit such information 

5 by the date determined by the Secretary in 

6 consultation with such responsible person. 

7 ‘‘(ii) FAILURE TO COMPLY.—If, by the 

8 date specified by the Secretary in the no9 tice under clause (i), the Secretary has not 

10 received the information described in para11 graph (1)(A), the Secretary shall—

12 ‘‘(I) transmit to the responsible 

13 person involved a notice specifying the 

14 information required to be submitted 

15 to the Secretary and stating that such 

16 responsible person shall be liable for 

17 the civil monetary penalties described 

18 in subparagraph (D) if such informa19 tion is not submitted to the Secretary 

20 within 30 days of the date on which 

21 such notice is transmitted; and 

22 ‘‘(II) include and prominently 

23 display, until such time as the Sec24 retary receives the information de25 scribed in paragraph (1)(A), as part 
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1 of the record of such trial in the data2 base described in subsection (j), a no3 tice stating that the results of such 

4 trials have not been reported as re5 quired by law. 

6 ‘‘(D) NONCOMPLIANCE.—

7 ‘‘(i) IN GENERAL.—If by the date that 

8 is 30 days after the date on which a notice 

9 described in subparagraph (C)(ii)(I) is 

10 transmitted, the Secretary has not received 

11 from the responsible person involved the 

12 information required pursuant to such no13 tice, the Secretary, after providing the op14 portunity for a hearing, order such respon15 sible person to pay a civil penalty of 

16 $10,000 for each day after such date that 

17 the information is not submitted. 

18 ‘‘(ii) WAIVERS.—In any case in which 

19 a responsible person described in clause (i) 

20 is a nonprofit entity, the Secretary may 

21 waive or reduce the penalties applicable 

22 under such clause to such person. 

23 ‘‘(E) NOTICE OF PUBLICATION OF DATA.—

24 If the responsible person is the manufacturer or 

25 distributor of the drug, biological product, or 
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1 device involved, the notice under subparagraphs 

2 (A)(i) and (C)(ii)(I) shall include a notice that 

3 the Secretary shall publish the data described 

4 in subsection (j)(3)(B) in the database if the re5 sponsible person has not submitted the informa6 tion specified in the notice transmitted by the 

7 date that is 6 months after the date of such no8 tice. 

9 ‘‘(F) PUBLICATION OF DATA.—Notwith10 standing section 301(j) of the Federal Food, 

11 Drug, and Cosmetic Act, section 1905 of title 

12 18, United States Code, or any other provision 

13 of law, if the responsible person is the manufac14 turer or distributor of the drug, biological prod15 uct, or device involved, and if the responsible 

16 person has not submitted to the Secretary the 

17 information specified in a notice transmitted 

18 pursuant to subparagraph (A)(i) or (C)(ii)(I) by 

19 the date that is 6 months after the date of such 

20 notice, the Secretary shall publish in the reg21 istry information that—

22 ‘‘(i) is described in subsection 

23 (j)(3)(B); and 

24 ‘‘(ii) the responsible person has sub25 mitted to the Secretary in any application,
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1 including a supplemental application, for 

2 the drug or device under section 505, 510, 

3 515, or 520 of the Federal Food, Drug, 

4 and Cosmetic Act or for the biological 

5 product under section 351. 

6 ‘‘(3) DATE SPECIFIED.—The date specified in 

7 this paragraph shall be the date that is 1 year from 

8 the earlier of—

9 ‘‘(A) the estimated completion date of the 

10 trial, submitted under subsection 

11 (j)(3)(B)(vi)(I)(hh); or 

12 ‘‘(B) the actual date of completion or ter13 mination of the trial. 

14 ‘‘(4) USE OF FUNDS.—

15 ‘‘(A) IN GENERAL.—The Secretary shall 

16 deposit the funds collected under paragraph (2) 

17 into an account and use such funds, in con18 sultation with the Director of the Agency for 

19 Healthcare Research and Quality, to fund stud20 ies that compare the clinical effectiveness of 2 

21 or more treatments for a disease or condition. 

22 ‘‘(B) FUNDING DECISIONS.—The Secretary 

23 shall award funding under subparagraph (A) 

24 based on a priority list established not later 

25 than 6 months after the date of enactment of 
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1 the FACT Act by the Director of the Agency 

2 for Healthcare Research and Quality and peri3 odically updated as determined appropriate by 

4 the Director. 

5 ‘‘(5) INCLUSION IN REGISTRY.—

6 ‘‘(A) GENERAL RULE.—The Secretary 

7 shall, pursuant to subsection (j)(5), include—

8 ‘‘(i) the data described in subsection 

9 (j)(3)(A) and submitted under the amend10 ments made by section 4(a) of the FACT 

11 Act in the registry described in subsection 

12 (j) as soon as practicable after receiving 

13 such data; and 

14 ‘‘(ii) the data described in clause (I) 

15 of subsection (j)(3)(B)(iv) and submitted 

16 under this subsection in the database de17 scribed in subsection (j) as soon as prac18 ticable after receiving such data. 

19 ‘‘(B) OTHER DATA.—

20 ‘‘(i) IN GENERAL.—The Secretary 

21 shall, pursuant to subsection (j)(5), include 

22 the data described in subclauses (II) 

23 through (X) of subsection (j)(3)(B)(iv) and 

24 submitted under this section in the data25 base described in subsection (j)—
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1 ‘‘(I) as soon as practicable after 

2 receiving such data; or 

3 ‘‘(II) in the case of data to which 

4 clause (ii) applies, by the date de5 scribed in clause (iii). 

6 ‘‘(ii) DATA DESCRIBED.—This clause 

7 applies to data described in clause (i) if—

8 ‘‘(I) the responsible person in9 volved requests a delay in the inclu10 sion in the database of such data in 

11 order to have such data published in 

12 a peer reviewed journal; and 

13 ‘‘(II) the Secretary determines 

14 that an attempt will be made to seek 

15 such publication. 

16 ‘‘(iii) DATE FOR INCLUSION IN REG17 ISTRY.—Subject to clause (iv), the date de18 scribed in this clause is the earlier of—

19 ‘‘(I) the date on which the data 

20 involved is published as provided for 

21 in clause (ii); or 

22 ‘‘(II) the date that is 18 months 

23 after the date on which such data is 

24 submitted to the Secretary. 
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1 ‘‘(iv) EXTENSION OF DATE.—The 

2 Secretary may extend the 18-month period 

3 described in clause (iii)(II) for an addi4 tional 6 months if the responsible person 

5 demonstrates to the Secretary, prior to the 

6 expiration of such 18-month period, that 

7 the data involved has been accepted for 

8 publication by a journal described in clause 

9 (ii)(I). 

10 ‘‘(v) MODIFICATION OF DATA.—Prior 

11 to including data in the database under 

12 clause (ii) or (iv), the Secretary shall per13 mit the responsible person to modify the 

14 data involved. 

15 ‘‘(6) EFFECT.—The information with respect to 

16 a clinical trial submitted to the Secretary under this 

17 subsection, including data published by the Sec18 retary pursuant to paragraph (2)(F), may not be 

19 submitted by a person other than the responsible

20 person as part of, or referred to in, an application 

21 for approval of a drug or device under section 505, 

22 510, 515, or 520 of the Federal Food, Drug, and 

23 Cosmetic Act or of a biological product under section 

24 351, unless the information is available from a
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1 source other than the registry or database described 

2 in subsection (j). 

3 ‘‘(m) PROCEDURES AND WAIVERS.—

4 ‘‘(1) SUBMISSION PRIOR TO NOTICE.—Nothing 

5 in subsections (k) through (l) shall be construed to 

6 prevent a principal investigator or a responsible per7 son from submitting any information required under 

8 this subsection to the Secretary prior to receiving 

9 any notice described in such subsections. 

10 ‘‘(2) ONGOING TRIALS.—A factually accurate 

11 statement that a clinical trial is ongoing shall be 

12 deemed to be information sufficient to demonstrate 

13 to the Secretary that the information described in 

14 subsections (k)(1)(A) and (l)(1)(A) cannot reason15 ably be submitted. 

16 ‘‘(3) INFORMATION PREVIOUSLY SUBMITTED.—

17 Nothing in subsections (k) through (l) shall be con18 strued to require the Secretary to send a notice to 

19 any principal investigator or responsible person re20 quiring the submission to the Secretary of informa21 tion that has already been submitted. 

22 ‘‘(4) SUBMISSION FORMAT AND TECHNICAL

23 STANDARDS.—

24 ‘‘(A) IN GENERAL.—The Secretary shall, 

25 to the extent practicable, accept submissions re-
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1 quired under this subsection in an electronic 

2 format and shall establish interoperable tech3 nical standards for such submissions. 

4 ‘‘(B) CONSISTENCY OF STANDARDS.—To 

5 the extent practicable, the standards established 

6 under subparagraph (A) shall be consistent 

7 with standards adopted by the Consolidated 

8 Health Informatics Initiative (or a successor or9 ganization to such Initiative) to the extent such 

10 Initiative (or successor) is in operation. 

11 ‘‘(5) TRIALS COMPLETED PRIOR TO ENACT12 MENT.—The Secretary shall establish procedures 

13 and mechanisms to allow for the voluntary submis14 sion to the database of the information described in 

15 subsection (j)(3)(B) with respect to clinical trials 

16 completed prior to the date of enactment of the 

17 FACT Act. In cases in which it is in the interest of 

18 public health, the Secretary may require that infor19 mation from such trials be submitted to the data20 base. Failure to comply with such a requirement 

21 shall be deemed to be a failure to submit informa22 tion as required under this section, and the appro23 priate remedies and sanctions under this section 

24 shall apply. 
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1 ‘‘(6) TRIALS NOT INVOLVING DRUGS, BIOLOGI2 CAL PRODUCTS, OR DEVICES.—The Secretary shall 

3 establish procedures and mechanisms to allow for 

4 the voluntary submission to the database of the in5 formation described in subsection (j)(3)(B) with re6 spect to clinical trials that do not involve drugs, bio7 logical products, or devices. In cases in which it is 

8 in the interest of public health, the Secretary may 

9 require that information from such trials be sub10 mitted to the database. Failure to comply with such 

11 a requirement shall be deemed to be a failure to sub12 mit information as required under this section, and 

13 the appropriate remedies and sanctions under this 

14 section shall apply. 

15 ‘‘(7) SUBMISSION OF INACCURATE INFORMA16 TION.—

17 ‘‘(A) IN GENERAL.—If the Secretary deter18 mines that information submitted by a principal 

19 investigator or a responsible person under this 

20 section is factually and substantively inaccurate, 

21 the Secretary shall submit a notice to the inves22 tigator or responsible person concerning such 

23 inaccuracy that includes—

24 ‘‘(i) a summary of the inaccuracies in25 volved; and 
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1 ‘‘(ii) a request for corrected informa2 tion within 30 days. 

3 ‘‘(B) AUDIT OF INFORMATION.—

4 ‘‘(i) IN GENERAL.—The Secretary 

5 may conduct audits of any information 

6 submitted under subsection (j). 

7 ‘‘(ii) REQUIREMENT.—Any principal 

8 investigator or responsible person that has 

9 submitted information under subsection (j) 

10 shall permit the Secretary to conduct the 

11 audit described in clause (i). 

12 ‘‘(C) CHANGES TO INFORMATION.—Any 

13 change in the information submitted by a prin14 cipal investigator or a responsible person under 

15 this section shall be reported to the Secretary 

16 within 30 days of the date on which such inves17 tigator or person became aware of the change 

18 for purposes of updating the registry or the 

19 database. 

20 ‘‘(D) FAILURE TO CORRECT.—If a prin21 cipal investigator or a responsible person fails

22 to permit an audit under subparagraph (B), 

23 provide corrected information pursuant to a no24 tice under subparagraph (A), or provide 

25 changed information under subparagraph (C), 
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1 the investigator or responsible person involved 

2 shall be deemed to have failed to submit infor3 mation as required under this section and the 

4 appropriate remedies and sanction under this 

5 section shall apply. 

6 ‘‘(E) CORRECTIONS.—

7 ‘‘(i) IN GENERAL.—The Secretary 

8 may correct, through any means deemed 

9 appropriate by the Secretary to protect 

10 public health, any information included in 

11 the registry or the database described in 

12 subsection (j) (including information de13 scribed or contained in a publication re14 ferred to under subclause (VI) of sub15 section (j)(3)(B)(iv)) that is—

16 ‘‘(I) submitted to the Secretary 

17 for inclusion in the registry or the 

18 database; and 

19 ‘‘(II) factually and substantively 

20 inaccurate or false or misleading. 

21 ‘‘(ii) RELIANCE ON INFORMATION.—

22 The Secretary may rely on any information 

23 from a clinical trial or a report of an ad24 verse event acquired or produced under the 

25 authority of section 351 of this Act or of 
36

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1 the Federal Food, Drug, and Cosmetic Act 

2 in determining whether to make correc3 tions as provided for in clause (i). 

4 ‘‘(iii) DETERMINATIONS RELATING TO

5 MISLEADING INFORMATION.—For purposes 

6 of clause (i)(II), in determining whether 

7 information is misleading, the Secretary 

8 shall use the standard described in section 

9 201(n) of the Federal Food, Drug, and 

10 Cosmetic Act that is used to determine 

11 whether labeling or advertising is mis12 leading. 

13 ‘‘(iv) RULE OF CONSTRUCTION.—This 

14 subparagraph shall not be construed to au15 thorize the disclosure of information if—

16 ‘‘(I) such disclosure would con17 stitute an invasion of personal pri18 vacy; 

19 ‘‘(II) such information concerns a 

20 method or process which as a trade 

21 secret is entitled to protection within 

22 the meaning of section 301(j) of the 

23 Federal Food, Drug, and Cosmetic 

24 Act;
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1 ‘‘(III) such disclosure would dis2 close confidential commercial informa3 tion or a trade secret, other than a 

4 trade secret described in subclause 

5 (II), unless such disclosure is nec6 essary—

7 ‘‘(aa) to make a correction 

8 as provided for under clause (i); 

9 and 

10 ‘‘(bb) protect the public 

11 health; or 

12 ‘‘(IV) if such disclosure relates to 

13 a biological product for which no li14 cense is in effect under section 351, a 

15 drug for which no approved applica16 tion is in effect under section 505(c) 

17 of the Federal Food, Drug, and Cos18 metic Act, or a device that is not 

19 cleared under section 510(k) of such 

20 Act or for which no application is in 

21 effect under section 515 of such Act. 

22 ‘‘(v) NOTICE.—In the case of a disclo23 sure under clause (iv)(III), the Secretary 

24 shall notify the manufacturer or distributor 
38

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1 of the drug, biological product, or device 

2 involved—

3 ‘‘(I) at least 30 days prior to 

4 such disclosure; or 

5 ‘‘(II) if immediate disclosure is 

6 necessary to protect the public health, 

7 concurrently with such disclosure. 

8 ‘‘(8) WAIVERS REGARDING CLINICAL TRIAL RE9 SULTS.—The Secretary may waive the requirements 

10 of subsections (k)(1) and (l)(1) that the results of 

11 clinical trials be submitted to the Secretary, upon a 

12 written request from the responsible person if the 

13 Secretary determines that extraordinary cir14 cumstances justify the waiver and that providing the 

15 waiver is in the public interest or consistent with the 

16 protection of public health. 

17 ‘‘(n) TRIALS CONDUCTED OUTSIDE OF THE UNITED

18 STATES.—

19 ‘‘(1) IN GENERAL.—With respect to clinical 

20 trials described in paragraph (2), the responsible 

21 person shall submit to the Secretary the information 

22 required under subclauses (II) through (X) of sub23 section (j)(3)(B)(iv). Failure to comply with this 

24 paragraph shall be deemed to be a failure to submit 

25 information as required under this section, and the 
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1 appropriate remedies and sanctions under this sec2 tion shall apply. 

3 ‘‘(2) CLINICAL TRIAL DESCRIBED.—A clinical 

4 trial is described in this paragraph if—

5 ‘‘(A) such trial is conducted outside of the 

6 United States; and 

7 ‘‘(B) the data from such trial is—

8 ‘‘(i) submitted to the Secretary as 

9 part of an application, including a supple10 mental application, for a drug or device 

11 under section 505, 510, 515, or 520 of the 

12 Federal Food, Drug, and Cosmetic Act or 

13 for the biological product under section 

14 351; or 

15 ‘‘(ii) used in advertising or labeling to 

16 make a claim about the drug, device, or bi17 ological product involved. 

18 ‘‘(o) DEFINITIONS; INDIVIDUAL LIABILITY.—

19 ‘‘(1) RESPONSIBLE PERSON.—

20 ‘‘(A) IN GENERAL.—In this section, the 

21 term ‘responsible person’ with respect to a clin22 ical trial, means—

23 ‘‘(i) if such clinical trial is the subject 

24 of an investigational new drug application 

25 or an application for an investigational de-
40

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1 vice exemption, the sponsor of such inves2 tigational new drug application or such ap3 plication for an investigational device ex4 emption; or 

5 ‘‘(ii) except as provided in subpara6 graph (B), if such clinical trial is not the 

7 subject of an investigational new drug ap8 plication or an application for an investiga9 tional device exemption—

10 ‘‘(I) the person that provides the 

11 largest share of the monetary support 

12 (such term does not include in-kind 

13 support) for the conduct of such trial; 

14 or 

15 ‘‘(II) in the case in which the 

16 person described in subclause (I) is a 

17 Federal or State agency, the principal 

18 investigator of such trial. 

19 ‘‘(B) NONPROFIT ENTITIES AND REQUEST20 ING PERSONS.—

21 ‘‘(i) NONPROFIT ENTITIES.—For pur22 poses of subparagraph (A)(ii)(I), if the 

23 person that provides the largest share of 

24 the monetary support for the conduct of 

25 the clinical trial involved is a nonprofit en-
41

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1 tity, the responsible person for purposes of 

2 this section shall be—

3 ‘‘(I) the nonprofit entity; or 

4 ‘‘(II) if the nonprofit entity and 

5 the principal investigator of such trial 

6 jointly certify to the Secretary that 

7 the principal investigator will be re8 sponsible for submitting the informa9 tion described in subsection (j)(3)(B) 

10 for such trial, the principal investi11 gator. 

12 ‘‘(ii) REQUESTING PERSONS.—For 

13 purposes of subparagraph (A)(ii)(I), if a 

14 person—

15 ‘‘(I) has submitted a request to 

16 the Secretary that the Secretary rec17 ognize the person as the responsible 

18 person for purposes of this section; 

19 and 

20 ‘‘(II) the Secretary determines 

21 that such person—

22 ‘‘(aa) provides monetary 

23 support for the conduct of such 

24 trial; 
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1 ‘‘(bb) is responsible for the 

2 conduct of such trial; and 

3 ‘‘(cc) will be responsible for 

4 submitting the information de5 scribed in subsection (j)(3)(B) 

6 for such trial; 

7 such person shall be the responsible person 

8 for purposes of this section. 

9 ‘‘(2) DRUG, DEVICE, BIOLOGICAL PRODUCT.—

10 In this section—

11 ‘‘(A) the terms ‘drug’ and ‘device’ have the 

12 meanings given such terms in section 201 of 

13 the Federal Food, Drug, and Cosmetic Act; and 

14 ‘‘(B) the term ‘biological product’ has the 

15 meaning given such term in section 351 of this 

16 Act. 

17 ‘‘(3) INDIVIDUAL LIABILITY.—

18 ‘‘(A) LIMITATION ON LIABILITY OF INDI19 VIDUALS.—No individual shall be liable for any 

20 civil monetary penalty under this section. 

21 ‘‘(B) INDIVIDUALS WHO ARE RESPONSIBLE

22 PERSONS.—If a responsible person under sub23 paragraph (A) or (B) of paragraph (1) is an 

24 individual, such individual shall be subject to
43

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1 the procedures and conditions described in sub2 section (k).’’. 

3 (c) AUTHORIZATION OF APPROPRIATIONS.—Section 

4 402 of the Public Health Service Act (42 U.S.C. 282), 

5 as amended by this section, is further amended by adding 

6 at the end the following: 

7 ‘‘(s) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated, such sums as may be 

9 necessary to carry out this section.’’. 

10 SEC. 4. REVIEW AND APPROVAL OF PROPOSALS FOR RE11 SEARCH. 

12 (a) AMENDMENTS.—Section 492A(a) of the Public 

13 Health Service Act (42 U.S.C. 289a–1(a)) is amended—

14 (1) in paragraph (1)(A), by striking ‘‘unless’’ 

15 and all that follows through the period and inserting 

16 the following: ‘‘unless—

17 ‘‘(i) the application has undergone re18 view in accordance with such section and 

19 has been recommended for approval by a 

20 majority of the members of the Board con21 ducting the review; 

22 ‘‘(ii) such Board has submitted to the 

23 Secretary a notification of such approval; 

24 and 
44

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1 ‘‘(iii) with respect to an application 

2 involving a clinical trial to which section 

3 402(j) applies, the principal investigator 

4 who has submitted such application has 

5 submitted to the Secretary for inclusion in 

6 the registry and the database described in 

7 section 402(j) the information described in 

8 paragraph (3)(A) and subclause (I) of 

9 paragraph (3)(B)(iv) of such section.’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(3) COST RECOVERY.—Nonprofit entities may 

12 recover the full costs associated with compliance 

13 with the requirements of paragraph (1) from the 

14 Secretary as a direct cost of research.’’. 

15 (b) REGULATIONS.—The Secretary of Health and 

16 Human Services shall modify the regulations promulgated 

17 at part 46 of title 45, Code of Federal Regulations, part 

18 50 of title 21, Code of Federal Regulations, and part 56 

19 of title 21, Code of Federal Regulations, to reflect the 

20 amendments made by subsection (a). 

21 SEC. 5. PROHIBITED ACTS. 

22 Section 301 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 331) is amended by adding at the end the 

24 following: 
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1 ‘‘(hh)(1) The entering into of a contract or other 

2 agreement by a responsible person or a manufacturer of 

3 a drug, biological product, or device with an individual 

4 who is not an employee of such responsible person or man5 ufacturer, or the performance of any other act by such 

6 a responsible person or manufacturer, that prohibits, lim7 its, or imposes unreasonable delays on the ability of such 

8 individual to—

9 ‘‘(A) discuss the results of a clinical trial at a 

10 scientific meeting or any other public or private 

11 forum; or 

12 ‘‘(B) publish the results of a clinical trial or a 

13 description or discussion of the results of a clinical 

14 trial in a scientific journal or any other publication. 

15 ‘‘(2) The entering into a contract or other agreement 

16 by a responsible person or a manufacturer of a drug, bio17 logical product, or device with an academic institution or 

18 a health care facility, or the performance of any other act 

19 by such a responsible person or manufacturer, that pro20 hibits, limits, or imposes unreasonable delays on the abil21 ity of an individual who is not an employee of such respon22 sible person or manufacturer to—

23 ‘‘(A) discuss the results of a clinical trial at a 

24 scientific meeting or any other public or private 

25 forum; or 
46

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1 ‘‘(B) publish the results of a clinical trial or a 

2 description or discussion of the results of a clinical 

3 trial in a scientific journal or any other publica4 tion.’’. 

5 SEC. 6. REPORTS. 

6 (a) IMPLEMENTATION REPORT.—Not later than 1 

7 year after the date of enactment of this Act, the Secretary 

8 of Health and Human Services shall submit to the appro9 priate committees of Congress a report on the status of 

10 the implementation of the requirements of the amend11 ments made by section 3 that includes a description of 

12 the number and types of clinical trials for which informa13 tion has been submitted under such amendments. 

14 (b) DATA COLLECTION.—

15 (1) IN GENERAL.—The Secretary of Health and 

16 Human Services shall enter into a contract with the 

17 Institute of Medicine for the conduct of a study con18 cerning the extent to which data submitted to the 

19 registry under section 402(j) of the Public Health 

20 Service Act (42 U.S.C. 282(j)) has impacted the 

21 public health. 

22 (2) REPORT.—Not later than 6 months after 

23 the date on which a contract is entered into under 

24 paragraph (1), the Institute of Medicine shall submit 

25 to the Secretary of Health and Human Services a 
47

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1 report on the results of the study conducted under 

2 such paragraph. Such report shall include rec3 ommendations for changes to the registry, the data4 base, and the data submission requirements that 

5 would benefit the public health.

Æ