I 
109TH CONGRESS 
1ST SESSION H. R. 3196 
To amend the Public Health Service Act to expand the scope of information 
required for the data bank on clinical trials of drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 30, 2005 
Mr. WAXMAN
(for himself, Mr. MARKEY, Mr. BROWN
of Ohio, Ms. 
SCHAKOWSKY, Mr. GENE GREEN of Texas, Mr. ALLEN, Mr. GEORGE 
MILLER of California, Mr. PALLONE, Mr. BERRY, Ms. SLAUGHTER, Mr. 
STUPAK, Mr. MCDERMOTT, Mr. HINCHEY, Mr. FRANK of Massachusetts, 
Mr. OBERSTAR, Mr. ANDREWS, Mr. MEEKS
of New York, Mr. 
DELAHUNT, Mr. MCNULTY, Mr. BERMAN, Mr. WEXLER, Ms. WOOLSEY, 
Ms. HERSETH, Mr. MCGOVERN, Mr. GRIJALVA, Mr. SANDERS, Mr. 
WEINER, Mr. CONYERS, Mr. KUCINICH, Mr. KENNEDY of Rhode Island, 
Mr. OLVER, and Mr. ABERCROMBIE) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to expand the 
scope of information required for the data bank on clin-
ical trials of drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Fair Access to Clinical 
Trials Act’’.
SEC. 2. CLINICAL TRIALS DATA BANK. 
(a) IN GENERAL.—Title IV of the Public Health 
Service Act (42 U.S.C. 281 et seq.) is amended— 
(1) in section 402, by striking subsection (j); 
and 
(2) by inserting after section 402 the following 
section: 
‘‘SEC. 402A. CLINICAL TRIALS DATA BANK. 
‘‘(a) IN GENERAL.— 
‘‘(1) DATA
BANK.—The Secretary, acting 
through the Director of NIH, shall establish, main-
tain, and operate a data bank of information on clin-
ical trials (including premarket and postmarket 
trials) for drugs, biological products, and devices. 
The activities of the data bank shall be integrated 
and coordinated with related activities of other agen-
cies of the Department of Health and Human Serv-
ices, and to the extent practicable, coordinated with 
other data banks containing similar information. 
‘‘(2) CONSULTATION.—The Secretary shall es-
tablish the data bank after consultation with the 
Commissioner of Food and Drugs, the directors of 
the appropriate agencies of the National Institutes 
of Health (including the National Library of Medi-
cine), and the Director of the Centers for Disease 
Control and Prevention.
‘‘(b) COLLECTION AND DISSEMINATION OF INFORMA-
TION.— 
‘‘(1) COLLECTION.—In carrying out subsection 
(a), the Secretary shall collect, catalog, store, and 
disseminate the information described in such sub-
section. 
‘‘(2) INCLUSION
OF
SUBMITTED
INFORMA-
TION.—All information on clinical trials required in 
this section to be submitted to the Secretary shall be 
included in the data bank as soon as practicable 
after the Secretary receives the information, subject 
to the provisions of this section. 
‘‘(3) DISSEMINATION.—The Secretary shall dis-
seminate information in the data bank through in-
formation systems, which shall include toll-free tele-
phone communications available to members of the 
public, to health care providers, and to researchers. 
‘‘(c) TRIALS SUBJECT TO REQUIREMENTS.— 
‘‘(1) TRIALS
OF
SAFETY
AND
EFFECTIVE-
NESS.—All clinical trials, whether federally funded 
or privately funded, conducted to test the safety or 
effectiveness (including comparative effectiveness) of 
a drug, biological product, or device (whether clinical 
trials of approved products or unapproved products)
are subject to the requirements of this section, ex-
cept as provided in paragraph (2). 
‘‘(2) EXCEPTIONS.—The requirements of para-
graph (1) do not apply to any of the following: 
‘‘(A) A clinical trial to determine the safe-
ty of a use of a drug if the trial is designed 
solely to detect major toxicities in the drug or 
to investigate pharmacokinetics, except that the 
requirements of such paragraph do apply if the 
trial is designed solely to investigate pharmaco-
kinetics in a special population or populations. 
‘‘(B) A small clinical trial to determine the 
feasibility of a device, or a trial to test proto-
type devices where the primary focus is feasi-
bility. 
‘‘(3) CERTAIN TRIALS.—The data bank may in-
clude information on a clinical trial described in sub-
paragraph (A) or (B) of paragraph (2) with the con-
sent of the responsible person for the trial. 
‘‘(4) RULE
OF
CONSTRUCTION.—This section 
may not be construed as applying to any classified 
information (as defined in subsection (l)). 
‘‘(d) REQUIRED INFORMATION.— 
‘‘(1) REGISTRATION OF TRIAL.—
‘‘(A) IN GENERAL.—Before commencing a 
clinical trial that is subject to subsection (c)(1), 
the responsible person for the trial shall register 
the trial with the Secretary. Such a registration 
shall be in such form and be submitted in such 
manner as the Secretary requires, and shall in-
clude the following information: 
‘‘(i) The medical condition being stud-
ied. 
‘‘(ii) A scientific title for the trial that 
includes the name of the intervention, the 
condition, and the outcome being studied. 
‘‘(iii) A statement of whether the trial 
has undergone research ethics review. The 
statement shall provide the date on which 
approval was obtained pursuant to such re-
view, or shall provide that such review is 
pending. In the case of a pending review, 
when approval is obtained, the responsible 
person shall provide an update that pro-
vides the date of the approval. 
‘‘(iv) The anticipated start date for 
the trial.
‘‘(v) The purpose of the trial, includ-
ing a statement of the interventions and 
comparisons involved. 
‘‘(vi) The eligibility criteria for par-
ticipation in the clinical trial. 
‘‘(vii) The funding source or sources 
of the trial. 
‘‘(viii) A statement that— 
‘‘(I) identifies the product as an 
unapproved product or as an approved 
product, as applicable; and 
‘‘(II) in the case of an approved 
product, identifies the trial as inves-
tigating the approved use of the prod-
uct or an unapproved use of the prod-
uct, as applicable. 
‘‘(ix) The estimated completion date 
for the trial. For purposes of this section, 
the term ‘completion date’ means the date 
of the final collection of data from subjects 
in the trial for the outcomes described in 
clause (vi). 
‘‘(x) A description of the primary and 
secondary outcomes to be examined in the 
trial, the time at which the primary and
secondary outcomes will be assessed, and 
the dates and details of any revisions to 
such outcomes. 
‘‘(xi) A statement of the hypothesis 
being tested in the trial. 
‘‘(xii) The total number of subjects 
anticipated to participate in the trial. 
‘‘(xiii) Contact information for the 
person to whom scientific inquiries regard-
ing the trial should be made. 
‘‘(xiv) Information on— 
‘‘(I) study design; 
‘‘(II) methods; 
‘‘(III) study phase; and 
‘‘(IV) study type. 
‘‘(xv) If the trial will test the effec-
tiveness of the use of a product with re-
spect to a serious or life-threatening dis-
ease or condition, the additional informa-
tion described in subparagraph (B)(i). 
‘‘(xvi) With respect to an individual 
who is not an employee of the responsible 
person for the trial or of the manufacturer 
of the product involved, information on any 
agreement that the responsible person or
manufacturer has entered into with such 
individual that restricts in any manner the 
ability of the individual to— 
‘‘(I) discuss the results of the 
trial at a scientific meeting or any 
other public or private forum; or 
‘‘(II) publish the results of the 
trial, or a description or discussion of 
the results of the trial, in a scientific 
or academic journal. 
‘‘(xvii) After the initial submission of 
the registration, periodic updates to reflect 
changes to information provided under this 
subparagraph. Such updates— 
‘‘(I) shall be provided not less 
frequently than once every six months 
until information on the results of the 
trial is submitted under paragraph 
(2)(A) or a waiver is provided under 
paragraph (2)(D); and 
‘‘(II) shall identify the dates on 
which the changes were made. 
‘‘(B) SERIOUS OR LIFE-THREATENING DIS-
EASES.—
‘‘(i) IN GENERAL.—For a clinical trial 
that will test the effectiveness of the use of 
a product with respect to a serious or life- 
threatening disease or condition, the addi-
tional information referred to in subpara-
graph (A)(xv) is the following: 
‘‘(I) A brief summary of the trial, 
provided in lay language. 
‘‘(II) A description of the loca-
tion of trial sites and the start date of 
the trial. 
‘‘(III) A point of contact for indi-
viduals desiring to enroll as subjects 
in the trial, including a single point of 
contact for all trial sites. 
‘‘(IV) The status of the trial with 
respect to the enrollment of subjects, 
stated for the trial in general and for 
individual trial sites. 
‘‘(V) Information that may be 
available— 
‘‘(aa) under a treatment in-
vestigational new drug applica-
tion, or a treatment investiga-
tional device exemption, that has
been submitted to the Secretary 
under section 561(c) of the Fed-
eral Food, Drug, and Cosmetic 
Act (relating to expanded access 
protocols); or 
‘‘(bb) as a Group C cancer 
drug (as defined by the National 
Cancer Institute). 
‘‘(ii) 
FORMATTING
FOR
GENERAL 
PUBLIC.—The information provided under 
clause (i) shall be in a format that can be 
readily accessed and understood by mem-
bers of the general public, including pa-
tients seeking to enroll as subjects in clin-
ical trials. 
‘‘(C) LABELS OF APPROVED PRODUCTS.— 
If a clinical trial registered under subparagraph 
(A) is investigating an approved product and 
the label for such product is included on the 
Internet site of the Food and Drug Administra-
tion, the information in the data bank con-
cerning the trial shall include an electronic link 
to such label for individuals accessing the data 
bank through the Internet.
‘‘(D) UNIQUE IDENTIFIER.—The Secretary 
shall assign to each clinical trial registered 
under subparagraph (A) a unique identifier for 
purposes of the data bank. The Secretary shall 
seek to ensure that such identifiers comply with 
international standards for identifying clinical 
trials. 
‘‘(E) 
MODIFICATIONS
REGARDING
RE-
QUIRED
INFORMATION.—Notwithstanding 
clauses (i) through (xvi) of subparagraph (A), 
requirements under such clauses may be modi-
fied by the Secretary, and additional require-
ments for the provision of information in reg-
istrations under such subparagraph may be es-
tablished by the Secretary, in order to ensure 
the nonmisleading disclosure of important infor-
mation from clinical trials. 
‘‘(2) SUBMISSION OF RESULTS OF TRIAL.— 
‘‘(A) IN GENERAL.—The responsible per-
son for a clinical trial that is subject to sub-
section (c)(1) shall provide to the Secretary in-
formation described in subparagraph (B) on the 
results of the trial, subject to subparagraph 
(D). The information shall be provided in the 
form of a structured abstract and in such man-
ner as the Secretary may require, in a form not 
likely to mislead or distort the results. 
‘‘(B) INFORMATION.—For purposes of sub-
paragraph (A), the information described in 
this subparagraph on the results of a clinical 
trial is the following: 
‘‘(i) 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 
paragraph (1)(A)(ix), or, if the trial is ter-
minated prior to completion, the termi-
nation date and reasons for such termi-
nation. 
‘‘(ii) Primary and secondary out-
comes, presented succinctly as quantitative 
data and as tests of hypotheses. 
‘‘(iii) Information on the number and 
type of significant adverse events in sub-
jects that may be associated with the prod-
uct involved, including such events for 
which a causal relationship has not been 
established. 
‘‘(iv) A citation to each covered article 
published in a peer-reviewed scientific or
academic journal. An article published in 
such a journal is a covered article for pur-
poses of this clause if— 
‘‘(I) the article discusses the re-
sults of the trial; 
‘‘(II) the responsible person or 
the principal investigator for the clin-
ical trial contributed to the article; 
and 
‘‘(III) MEDLINE includes a ci-
tation to the article. 
‘‘(v) 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 inde-
pendent of the sponsor. 
‘‘(vi) If the trial is investigating an 
unapproved product or an unapproved use 
of an approved product, a statement, as 
appropriate, displayed prominently at the 
beginning of information in the data bank 
concerning the trial, that the Food and 
Drug Administration— 
‘‘(I) is currently reviewing an ap-
plication for approval of such product
or use to determine whether the use is 
safe and effective; 
‘‘(II) has disapproved an applica-
tion for approval of such product or 
use; 
‘‘(III) has reviewed an applica-
tion for approval of such product or 
use but the application was withdrawn 
prior to approval or disapproval; or 
‘‘(IV) has not reviewed or ap-
proved such product or use as safe 
and effective. 
‘‘(vii) If data from the trial has not 
been submitted to the Food and Drug Ad-
ministration, an explanation of why it has 
not been submitted. 
‘‘(viii) A statement providing such in-
formation on the protocol for the trial as 
may be necessary to evaluate the results of 
the trial. Criteria issued by the Secretary 
under subsection (k) shall include criteria 
regarding information that is required for 
purposes of such statements. 
‘‘(ix) In the group of subjects receiv-
ing the product, and in each comparison
group of subjects, the percentage of indi-
viduals who ceased participation as sub-
jects and the reasons for ceasing participa-
tion. 
‘‘(x) Basic demographic information 
on subjects. 
‘‘(xi) With respect to an individual 
who is not an employee of the responsible 
person for the trial or of the manufacturer 
of the product involved, information (to the 
extent not submitted under paragraph 
(1)(A)(xvi) on any agreement that the re-
sponsible person or manufacturer has en-
tered into with such individual that re-
stricts in any manner the ability of the in-
dividual to— 
‘‘(I) discuss the results of the 
trial at a scientific meeting or any 
other public or private forum; or 
‘‘(II) publish the results of the 
trial, or a description or discussion of 
the results of the trial, in a scientific 
or academic journal. 
‘‘(xii) After the initial submission of 
information on the results, periodic up-
dates to reflect changes in the information 
submitted pursuant to this subparagraph. 
Such updates— 
‘‘(I) shall be provided not less 
frequently than once every six months 
during the 10-year period beginning 
on the date on which information on 
the results is due under subparagraph 
(C)(i); and 
‘‘(II) shall identify the dates on 
which the changes were made. 
‘‘(C) DUE DATE FOR RESULTS.— 
‘‘(i) IN
GENERAL.—Information re-
quired under subparagraph (A) on the re-
sults of a clinical trial shall be submitted 
to the Secretary— 
‘‘(I) not later than one year after 
the earlier of— 
‘‘(aa) the estimated comple-
tion date of the trial, as sub-
mitted 
under 
paragraph 
(1)(A)(ix); or 
‘‘(bb) the actual completion 
date of the trial, or the actual 
date of the termination of the
trial before completion, as appli-
cable; or 
‘‘(II) by such later date as may 
apply under an extension under clause 
(iii). 
‘‘(ii) REPORTS REGARDING DUE DATE 
IN EXCESS OF THREE YEARS.—If the due 
date under clause (i) for information on 
the results of a clinical trial is a date that 
is more than three years after the date on 
which the trial was registered under para-
graph (1)(A), the following applies: 
‘‘(I) Upon the expiration of such 
three-year period, the responsible per-
son for the trial shall submit to the 
Secretary a report that describes the 
progress being made toward submis-
sion of the results. 
‘‘(II) For each one-year period 
that lapses after the submission of the 
report under subclause (I), the re-
sponsible person shall submit to the 
Secretary an additional report that 
describes such progress, except that