[Congressional Record Volume 151, Number 20 (Monday, February 28, 2005)]
[Senate]
[Pages S1797-S1804]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself, Mr. Grassley, Mr. Johnson, and Mr. 
        Wyden):
  S. 470. A bill to amend the Public Health Service Act to expand the 
clinical trials drug data bank; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to introduce the Fair Access to 
Clinical Trials, FACT, Act. I want to begin by thanking Senator 
Grassley, Senator Johnson, and Senator Wyden for joining me in 
introducing this legislation. Our bill will create an electronic 
databanks for clinical trials of drugs, biological products, and 
medical devices. Such a databank will ensure that physicians, 
researchers, the general public, and patients seeking to enroll in 
clinical trials have access to basic information about those trials. It 
will require manufacturers and other researchers to reveal the results 
of clinical trials so that clinically important information will be 
available to all Americans, and physicians will have all the necessary 
information to make appropriate treatment decisions for their patients.
  Events of the past year have made it clear that such a databank is 
needed. First, serious questions were raised about the effectiveness 
and safety of antidepressants when used in children and youth. It has 
now become clear that the existing data indicates that these drugs may 
very well put children at risk. However, because the data from 
antidepressant clinical trials was not publicly available, it took 
years for this risk to be realized. In the meantime, millions of 
children have been prescribed antidepressants by well-meaning 
physicians. While these drugs undoubtedly helped many of these 
children, they also led to greater suffering for others. Recently, it 
has been suggested that the risk of antidepressants might even extend 
beyond children.

[[Page S1798]]

  The news is similarly disturbing for a popular class of painkillers 
known as Cox-2 inhibitors. These medicines, taken by millions of 
Americans, have been associated with an increased risk of 
cardiovascular adverse events, such as heart attack and stroke. It has 
been suggested that one of these medicines, which has since been pulled 
from the market, may be responsible for tens of thousands of deaths.
  Unfortunately, antidepressants and Cox-2 inhibitors are just two 
examples of a story that has become all too common. It has been 
suggested that negative data might actually have been suppressed; and 
if this is discovered to be the case, those responsible should be dealt 
with harshly. However, because of what is known as ``publication 
bias,'' the information available to the public and physicians can be 
misleading even without nefarious motives. The simple fact is that a 
study with a positive result is far more likely to be published, and 
thus publicly available, than a study with a negative result. 
Physicians and patients hear the good news, but rarely the bad news. In 
the end, the imbalance of available information hurts patients.
  Our bill would correct the imbalance of information, and prevent 
manufacturers from suppressing negative data. It would do so by 
creating a two-part databank, consisting of an expansion of 
clinicaltrials.gov--an existing registry that is operated by the 
National Library of Medicine, NLM--and a new database for clinical 
trial results.
  Under the FACT Act, the registry would continue to operate as a 
resource for patients seeking to enroll in clinical trials for drugs 
and biological products intended to treat serious or life-threatening 
conditions--and for the first time, it would also include medical 
device trials. The new results database would include all trials, 
except for preliminary safety trials, and would require the submission 
of results data.
  Our legislation would enforce the requirement to submit information 
to the databank in two ways. First, by requiring registration as a 
condition of Institutional Review Board, IRB, approval, no trial could 
begin without submitting preliminary information to the registry and 
database. This information would include the purpose of the trial, the 
estimated date of trial completion, as well as all of the information 
necessary to help patients to enroll in the trial.
  Once the trial is completed, the researcher or manufacturer would be 
required to submit the results to the database. If they refuse to do 
so, they would be subject to monetary penalties or, in the case of 
federally funded research, a restriction on future funding. It is my 
belief that these enforcement mechanisms will ensure broad compliance. 
However, in the rare case where a manufacturer does not comply, this 
legislation also gives the Food and Drug Administration, FDA, the 
authority to publicize the required information.
  Let me also say that any time you are collecting large amounts of 
data and making it public, protecting patient privacy and 
confidentiality must be paramount. Our legislation would in no way 
threaten that privacy. The simple fact is that under this bill, no 
individually identifiable information would be available to the public.
  I believe that the establishment of a clinical trials databank is 
absolutely necessary for the health and well-being of the American 
public. But I would also like to highlight two other benefits that such 
a databank will have. First, it has the potential to reduce health care 
costs. Studies have shown that publication bias also leads to a bias 
toward new and more expensive treatment options. A databank could help 
make it clear that, in some cases, less expensive treatments are just 
as effective for patients.
  In addition, a databank will ensure that the sacrifice made by 
patients who enroll in clinical trials is not squandered. Many patients 
would be less willing to participate in trials if they understood that 
the data are unlikely to be made public if the results of the trial are 
negative. We owe it to patients to make sure that their participation 
in a trial will benefit other individuals suffering from the same 
illness or condition.
  The problems associated with publication bias have recently drawn 
more attention from the medical community, and there is broad consensus 
that a clinical trials registry is one of the best ways to address the 
issue. Accordingly, the American Medical Association, AMA, has 
recommended the creation of such a databank, and the major medical 
journals have established a policy that they will only publish the 
results of trials that were registered in a public database before the 
trial began. Our legislation meets all of the minimum criteria for a 
trial registry set out by the International Committee of Medical 
Journal Editors.

  To its credit, the pharmaceutical industry has also acknowledged the 
problem, and has created a database to which manufacturers can 
voluntarily submit clinical trials data. I applaud this step. However, 
if our objective is to provide the public with a complete and 
consistent supply of information, a voluntary database is unlikely to 
achieve that goal. Some companies will provide information, but others 
may decide not to participate. We need a clinical trials framework that 
is not just fair to all companies, but provides patients with peace of 
mind that they will receive complete information about the medicines 
they rely on.
  The American drug industry is an extraordinary success story. As a 
result of the innovations that this industry has spawned, millions of 
lives have been improved and saved in our country and around the globe. 
Because of the importance of these medicines to our health and well-
being, I have consistently supported sound public policies to help the 
industry to succeed. This legislation aims to build upon the successes 
of this industry, and help ensure that the positive changes to our 
health care system that prescription drugs have brought are not 
undermined by controversies such as the ones now surrounding 
antidepressants and Cox-2 inhibitors, which are at least in part based 
on a lack of public information. This bill will help ensure that well-
informed patients will use new and innovative medicines.
  I look forward to working with industry, physicians, the medical 
journals, patient groups, and my colleagues--including the Chairman and 
the Ranking Member of the Health, Education, Labor, and Pensions 
Committee, Senator Enzi and Senator Kennedy--to move this legislation 
forward. This bill has already been endorsed by the National 
Organization for Rare Disorders, Consumers Union, the Elizabeth Glaser 
Pediatric AIDS Foundation, the American Academy of Child and Adolescent 
Psychiatry, the American Psychiatric Association, the New England 
Journal of Medicine, and the National Women's Health Network. I thank 
these organizations for lending their expertise as we crafted this 
legislation.
  The creation of a clinical trials databank is a critical step toward 
ensuring the safety of drugs, biological products, and devices in this 
country--but it should not be the end of our efforts. I believe that 
other steps are necessary to fully restore patient confidence in the 
safety of the medicines they rely on. I have already announced my 
intention to introduce another piece of legislation that will create an 
Office of Patient Protection within the FDA, which will be responsible 
for ensuring the safety of prescription drugs once they are on the 
market. I look forward to introducing this bill in the coming weeks.
  Clinical trials are critical to protecting the safety and health of 
the American public, and for this reason, trial results must not be 
treated as information that can be hidden from scrutiny. Recent events 
have made it clear that a clinical trials databank is needed. Patients 
and physicians agree that such a databank is in the interest of the 
public health. I urge my colleagues to support this legislation, and I 
am hopeful that it will become law as soon as possible.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 470

       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''.

[[Page S1799]]

     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;
       ``(gg) the trial purpose;
       ``(hh) the estimated completion date for the trial; and
       ``(ii) 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

[[Page S1800]]

     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

[[Page S1801]]

     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

[[Page S1802]]

     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

[[Page S1803]]

     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.

  Mr. GRASSLEY. Mr. President, earlier today, Senate Bill 470 was 
introduced. I am pleased to sponsor the Fair Access to Clinical Trials 
Act of 2005, with Senator Dodd. I am co-sponsoring this legislation as 
part of a sustained effort to restore public confidence in the Federal 
Government's food and drug safety agency. Enactment of this bill will 
be a meaningful step toward greater transparency and accountability in 
clinical trials and the scientific process.
  The Food and Drug Administration earned its prized reputation through 
decades of good work on behalf of the American people. The FDA's drug 
approval process has long been considered the ``Good Housekeeping Seal 
of Approval.'' However, the Vioxx disaster and its aftermath have 
shaken the public's confidence. American consumers demand and deserve 
assurances that the medicines in their cabinets are safe. The health 
and safety of the public must be the FDA's first and only concern. 
Unfortunately, reforms at the FDA are necessary to place that mission 
front and center once again.
  I began my oversight of the FDA last year in response to concerns 
about the reluctance of the FDA to provide information to the public 
about the increased suicidal risks for young people taking anti-
depressants. Last November, I chaired a groundbreaking hearing on drug 
safety, the FDA and Vioxx. That hearing and other critical drug safety 
concerns of the past year highlighted the need for reforms and more 
stringent oversight of the FDA.
  Sometimes congressional scrutiny of agency mismanagement can lead to 
necessary reforms. Sometimes an agency will act on its own to enhance 
its credibility. I have been pressing for reforms--both administrative 
and legislative--to bring about greater responsiveness and transparency 
at the FDA. The risks and benefits of prescription drugs should be 
readily available to patients and doctors seeking to make informed 
decisions.
  The FACT Act will expand www.clinicaltrials.gov to create a publicly 
accessible national data bank of clinical trial information comprised 
of a clinical trial registry and a clinical trial results database. The 
legislation will foster transparency and accountability in health-
related intervention research and development and ensure that the 
scientific community and the general public have access to basic 
information about clinical trials. Importantly, the FACT Act will 
maintain clinicaltrials.gov as a registry for patients and physicians 
seeking information about ongoing clinical trials for serious or life-
threatening diseases and conditions. The legislation will also prevent 
companies from withholding clinically important information about their 
products.
  The FACT Act will 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; 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; require the Food and Drug 
Administration (FDA) to make internal drug approval and safety reviews 
publicly available; build on the successful model of 
www.clinicaltrials.gov, which was established in 1997. The web site 
will continue to be run by the National Library of Medicine at the 
National Institutes of Health, with assistance from the FDA; apply to 
clinical trials for drugs, biologics, and medical devices. All trials 
must be registered in the database in order to obtain approval from a 
U.S. Institutional Review Board; require that foreign trials that are 
submitted to the FDA or used in advertising to U.S. physicians be 
registered in the database at the time of submission; require that 
researchers promptly disclose the objectives, eligibility criteria, 
sources of funding, and anticipated timeline of clinical trials. The 
bill's standards will meet all of the minimum criteria for a trial 
registry set out by the International Committee of Medical Journal 
Editors on September 8, 2004; mandate that the results of clinical 
trials be available to doctors and patients. Recognizing that the peer 
review process is the best safeguard for scientific accuracy, the bill 
provides time for researchers to publish their results. The disclosure 
of important trial results satisfies the recommendation of the American 
Medical Association; establish strong enforcement mechanisms. The bill 
will provide for civil monetary penalties of up to $10,000 per day for 
sponsors who refuse to comply. Monetary penalties will be earmarked for 
studies that compare clinical therapies; provide authority to audit the 
completeness and accuracy of the information in the registry; and 
ensure that the Food and Drug Administration has the authority to 
correct false or misleading statements about the results of clinical 
trials.
  Later this month I will also introduce legislation to establish an 
independent office of drug safety in the Food and Drug Administration. 
Today's legislation is an important step toward reforming the FDA. I 
urge my colleagues to join me in this effort by cosponsoring this 
important legislation.
  Mr. JOHNSON. Mr. President, today I join several of my colleagues in 
introducing a very important piece of legislation that will improve 
access to information about prescription drugs for

[[Page S1804]]

patients and their doctors. Today, Senators Dodd, Grassley, Wyden and I 
are introducing the Fair Access to Clinical Trials Act or FACT Act. I 
commend my colleagues for their hard work on this legislation. I also 
thank them for their commitment to ensuring that finally, objective, 
unbiased information can be put in the hands of consumers and doctors, 
reducing negative outcomes, improving patient care, and ultimately 
reducing costs of medications.
  In recent months, we have learned that certain prescription drugs on 
the market today may not be as safe as we once thought. 
GlaxoSmithKline's antidepressant drug, Paxil, was found to increase the 
risk of suicide among adolescents. Further investigation of this issue 
indicated that some manufacturers of antidepressants highlighted 
positive findings of tests on youngsters, while playing down negative 
or inconclusive ones. In addition, the arthritis medication, Vioxx, was 
pulled off the market due to negative study findings, and over 27,000 
sudden cardiac deaths and heart attacks may have been caused by this 
medication.
  I find it unacceptable that current law does not require that the 
results of these studies on Paxil and Vioxx be made readily available 
to doctors and their patients. It is unacceptable that today, much of 
the information consumers and doctors rely on to make decisions about 
the medications they use are based on incomplete information. Patients 
are often swayed by direct-to-consumer drug advertisements and doctors 
must rely on the information they learn at drug company sponsored 
conferences. Access to complete information about prescription drugs is 
an important consumer issue, and that is why I am introducing this 
legislation that would require pharmaceutical companies to fully 
disclose clinical drug trial information in a public database before 
medications are introduced on the shelves.
  Under my legislation, all studies on medicines like Paxil and Vioxx 
would be listed in a public drug trial registry database. The database 
would include all the studies, both good and bad, the studies that are 
conducted after the drug is already on the market, and even the studies 
that are discontinued. Doctors and patients would have access to all 
different types of information so they could make a clear decision on 
which drugs are best for any circumstance.
  The drug trial database established under this legislation would be 
accessible to the public on a governmental Web site. The database will 
include information about the sponsor of the drug trial, the parameters 
of the study, and the outcome or results of the trial. Medical 
professionals ought to have complete information available when 
prescribing medications, and consumers should be aware of all the 
effects prescription drugs can have when taken over a period of time. 
Common sense tells us we need transparency in the prescription drug 
industry when it comes to the effectiveness of medications, and this 
database works towards that goal and will help to hold drug companies 
accountable for their products on the market.
  I hope the Senate and House will take up this bill and pass it. It 
addresses an important consumer right-to-know issue that will help to 
ensure that patients and doctors have the best, most accurate 
information at their fingertips when making life-altering medical 
decisions.
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