[Congressional Record (Bound Edition), Volume 156 (2010), Part 12]
[House]
[Pages 16366-16370]
[From the U.S. Government Publishing Office, www.gpo.gov]




            IMPROVING ACCESS TO CLINICAL TRIALS ACT OF 2009

  Mr. McDERMOTT. Mr. Speaker, I move to suspend the rules and pass the 
bill (S. 1674) to provide for an exclusion under the Supplemental 
Security Income program and the Medicaid program for compensation 
provided to individuals who participate in clinical trials for rare 
diseases or conditions.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                S. 1674

       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 ``Improving Access to Clinical 
     Trials Act of 2009''.

     SEC. 2. FINDINGS.

       Congress finds the following:
       (1) Advances in medicine depend on clinical trial research 
     conducted at public and private research institutions across 
     the United States.
       (2) The challenges associated with enrolling participants 
     in clinical research studies are especially difficult for 
     studies that evaluate treatments for rare diseases and 
     conditions (defined by the Orphan Drug Act as a disease or 
     condition affecting fewer than 200,000 Americans), where the 
     available number of willing and able research participants 
     may be very small.
       (3) In accordance with ethical standards established by the 
     National Institutes of Health, sponsors of clinical research 
     may provide payments to trial participants for out-of-pocket 
     costs associated with trial enrollment and for the time and 
     commitment demanded by those who participate in a study. When 
     offering compensation, clinical trial sponsors are required 
     to provide such payments to all participants.
       (4) The offer of payment for research participation may 
     pose a barrier to trial enrollment when such payments 
     threaten the eligibility of clinical trial participants for 
     Supplemental Security Income and Medicaid benefits.
       (5) With a small number of potential trial participants and 
     the possible loss of Supplemental Security Income and 
     Medicaid benefits for many who wish to participate, clinical 
     trial research for rare diseases and conditions becomes 
     exceptionally difficult and may hinder research on new 
     treatments and potential cures for these rare diseases and 
     conditions.

     SEC. 3. EXCLUSION FOR COMPENSATION FOR PARTICIPATION IN 
                   CLINICAL TRIALS FOR RARE DISEASES OR 
                   CONDITIONS.

       (a) Exclusion From Income.--Section 1612(b) of the Social 
     Security Act (42 U.S.C. 1382a(b)) is amended--
       (1) by striking ``and'' at the end of paragraph (24);
       (2) by striking the period at the end of paragraph (25) and 
     inserting ``; and''; and
       (3) by adding at the end the following:
       ``(26) the first $2,000 received during a calendar year by 
     such individual (or such spouse) as compensation for 
     participation in a clinical trial involving research and 
     testing of treatments for a rare disease or condition (as 
     defined in section 5(b)(2) of the Orphan Drug Act), but only 
     if the clinical trial--
       ``(A) has been reviewed and approved by an institutional 
     review board that is established--
       ``(i) to protect the rights and welfare of human subjects 
     participating in scientific research; and
       ``(ii) in accord with the requirements under part 46 of 
     title 45, Code of Federal Regulations; and
       ``(B) meets the standards for protection of human subjects 
     as provided under part 46 of title 45, Code of Federal 
     Regulations.''.
       (b) Exclusion From Resources.--Section 1613(a) of the 
     Social Security Act (42 U.S.C. 1382b(a)) is amended--
       (1) by striking ``and'' at the end of paragraph (15);
       (2) by striking the period at the end of paragraph (16) and 
     inserting ``; and''; and
       (3) by inserting after paragraph (16) the following:
       ``(17) any amount received by such individual (or such 
     spouse) which is excluded from income under section 
     1612(b)(26) (relating to compensation for participation in a 
     clinical trial involving research and testing of treatments 
     for a rare disease or condition).''.
       (c) Medicaid Exclusion.--
       (1) In general.--Section 1902(e) of the Social Security Act 
     (42 U.S.C. 1396a(e)), is amended by adding at the end the 
     following:
       ``(14) Exclusion of compensation for participation in a 
     clinical trial for testing of treatments for a rare disease 
     or condition.--The first $2,000 received by an individual 
     (who has attained 19 years of age) as compensation for 
     participation in a clinical trial meeting the requirements of 
     section 1612(b)(26) shall be disregarded for purposes of 
     determining the income eligibility of such individual for 
     medical assistance under the State plan or any waiver of such 
     plan.''.
       (2) Conforming amendment.--Section 1902(a)(17) of such Act 
     (42 U.S.C. 1396a(a)(17)) is amended by inserting ``(e)(14),'' 
     before ``(l)(3)''.
       (d) Effective Date.--The amendments made by this section 
     shall take effect on the date that is the earlier of--
       (1) the effective date of final regulations promulgated by 
     the Commissioner of Social Security to carry out this section 
     and such amendments; or
       (2) 180 days after the date of enactment of this Act.
       (e) Sunset Provision.--This Act and the amendments made by 
     this Act are repealed on the date that is 5 years after the 
     date of the enactment of this Act.

     SEC. 4. STUDY AND REPORT.

       (a) Study.--Not later than 36 months after the effective 
     date of this Act, the Comptroller General of the United 
     States shall conduct a study to evaluate the impact of this 
     Act on enrollment of individuals who receive Supplemental 
     Security Income benefits under title XVI of the Social 
     Security Act (referred to in this section as ``SSI 
     beneficiaries'') in clinical trials for rare diseases or 
     conditions. Such study shall include an analysis of the 
     following:
       (1) The percentage of enrollees in clinical trials for rare 
     diseases or conditions who were SSI beneficiaries during the 
     3-year period prior to the effective date of this Act as 
     compared to such percentage during the 3-year period after 
     the effective date of this Act.
       (2) The range and average amount of compensation provided 
     to SSI beneficiaries who participated in clinical trials for 
     rare diseases or conditions.
       (3) The overall ability of SSI beneficiaries to participate 
     in clinical trials.
       (4) Any additional related matters that the Comptroller 
     General determines appropriate.
       (b) Report.--Not later than 12 months after completion of 
     the study conducted under subsection (a), the Comptroller 
     General shall submit to Congress a report containing the 
     results of such study, together with recommendations for such 
     legislation and administrative action as the Comptroller 
     General determines appropriate.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Washington (Mr. McDermott) and the gentleman from Louisiana (Mr. 
Boustany) each will control 20 minutes.
  The Chair recognizes the gentleman from Washington.


                             General Leave

  Mr. McDERMOTT. I ask unanimous consent that all Members have 5 
legislative days in which to revise and extend their remarks and 
include extraneous material on S. 1674.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Washington?
  There was no objection.
  Mr. McDERMOTT. Mr. Speaker, many individuals who suffer from rare 
diseases or conditions currently face obstacles to participating in 
clinical research trials that may extend or improve their quality of 
life.
  The Improving Access to Clinical Trials Act, which passed the Senate 
on August 5, 2010, by unanimous consent, would eliminate these 
barriers. This legislation would prohibit disabled beneficiaries who 
receive assistance from the Supplemental Security Income, or SSI 
program, from participating in clinical trials.
  It is standard practice to reimburse clinical trial participants, not 
only for direct expenses associated with participation in such trials 
but also to reimburse them for time committed for their participation.
  Moreover, it is the policy of research institutions to treat all 
clinical trial enrollees in a consistent manner. As a result, if 
compensation for expenses and time is paid to one trial enrollee, it

[[Page 16367]]

must be paid to all. The current program rules under the SSI program 
regarding compensation or reimbursement from clinical trials has 
inadvertently created an obstacle for enrollment in such trials that 
can lead to life-saving therapies.
  For example, approximately half of all adults with cystic fibrosis 
are SSI recipients. If one of these recipients were to participate in a 
clinical trial and received reimbursement for their commitment, that 
compensation would lead the Social Security Administration to 
redetermine whether the individual continues to meet the income and 
asset tests used to determine eligibility for the SSI program.

                              {time}  1120

  Thus even a modest reimbursement for clinical trial participation may 
prevent the majority of individuals from enrolling in trials because, 
under the SSI income and asset limits, it could potentially trigger a 
loss of their SSI benefit. As a result of this risk, very few SSI 
recipients who suffer from cystic fibrosis participate in clinical 
trials.
  Given the large number of recipients with cystic fibrosis, this may 
have the undesired effect of slowing the pace of cystic fibrosis 
clinical research for all Americans, including the approval process for 
promising therapies that are already in the pipeline or waiting to be 
tested. The development of new treatments for rare diseases would 
benefit not only those who suffer from such conditions but the Nation 
as well.
  SSI rules should not force recipients to choose between their current 
income support and health coverage and their long-term ability to 
manage and potentially overcome the disease that has disabled them.
  In May of 2008, a number of my Democratic and Republican colleagues 
from the Ways and Means Committee joined me in sending a letter to the 
Commissioner of the Social Security Administration. We urged him to 
consider practical steps to allow SSI recipients to maintain their 
eligibility for the SSI and Medicaid benefits while participating in 
potentially lifesaving clinical trials. The Commissioner informed us 
that such a solution would require a legislative change in the law.
  The legislation before us today is very similar to the bipartisan 
legislation that was introduced in the House by Representatives Ed 
Markey and Cliff Stearns in June of 2009. The bill excludes the first 
$2,000 received as compensation or reimbursement in a clinical trial 
from the income and asset eligibility limits in the SSI program. It 
also would exclude the first $2,000 in compensation from the income 
tests in Medicaid.
  Additionally, the legislation would require the Government 
Accountability Office to conduct an evaluation of the impact of this 
bill on enrollment of SSI recipients who participate in clinical 
trials. The CBO has determined that this provision, which is scheduled 
to sunset in 5 years following enactment, has little to no cost. 
Eliminating the obstacles faced by SSI recipients who suffer from a 
rare condition could lead to potentially lifesaving treatments or 
therapies that can improve the quality of life for those who suffer 
from these diseases.
  Permitting the SSI recipients to participate in clinical research 
trials is the right thing to do.
  I reserve the balance of my time.
  Mr. BOUSTANY. Mr. Speaker, I yield myself such time as I may consume.
  I rise in support of the Improving Access to Clinical Trials Act 
before us today.
  Mr. Speaker, I was an original cosponsor of the House version of this 
bill introduced in June 2009. To date, there are 141 Members from both 
sides of the aisle who have cosponsored that House bill. The Senate 
version passed unanimously last month, and I urge all Members to 
support this needed legislation.
  This bill would allow Americans with serious diseases to retain the 
benefits they need while they help find treatments and cures for 
themselves and others with similar afflictions.
  In the field of medicine, clinical trials are an important tool to 
find new and more effective treatments for incapacitating and often 
deadly diseases. Under current NIH standards, sponsors of clinical 
research may provide modest payments to trial participants for their 
out-of-pocket costs and time spent participating in the trial. Such 
payments average about $500 per participant. That compensation must be 
provided to all participants if it is offered to any to ensure 
financial concerns don't affect the outcome of such trials. That means 
individuals cannot opt to not be paid for their participation in 
clinical trials.
  Yet, under current law, such payments also must be counted as income 
in determining an individual's eligibility for SSI disability payments 
and Medicaid coverage, if they receive those benefits. That means that 
participating in a clinical trial could reduce or even eliminate those 
important benefits for some individuals. That forces individuals to 
choose between maintaining their current health and disability benefits 
and the chance to participate in a clinical trial that could improve or 
even cure their condition, as well as help others like them in the 
future. And when a large share of people with rare diseases like cystic 
fibrosis are receiving SSI benefits, this policy may actually prevent 
trials from going forward altogether, since it restricts the already 
small number of people able to participate in the trial in the first 
place.
  So this bill makes a simple correction. Over the next 5 years, it 
directs the SSI and Medicaid programs to ignore modest compensation 
that program beneficiaries might receive for participation in clinical 
trials when determining program eligibility. This is consistent with 
current SSI program exemptions, as well as common sense. Importantly, 
given the small number of people affected and the program red tape this 
would actually prevent, the Congressional Budget Office estimates that 
this bill will result in no net costs to the Federal Government. And 
the legislation directs the Government Accountability Office to study 
this issue to ensure the bill is having its intended effects of 
assisting people with diseases and improving participation in clinical 
trials while holding the Federal program costs down.
  Mr. Speaker, this is a reasonable approach that merits our support.
  I reserve the balance of my time.
  Mr. McDERMOTT. Mr. Speaker, I yield 5 minutes to the gentleman from 
Massachusetts (Mr. Markey).
  Mr. MARKEY of Massachusetts. I thank the gentleman from Washington 
State so much, and I thank my friend from Florida (Mr. Stearns), my 
cosponsor of this legislation and my cochair of the Congressional 
Cystic Fibrosis Caucus, for his incredible work in helping to bring 
this moment into being.
  The Improving Access to Clinical Trials Act will enable more 
individuals with rare diseases to participate in clinical trials 
offering hope for cures to devastating diseases like cystic fibrosis. 
This bill is urgently needed.
  Current eligibility requirements for Medicaid and Supplemental 
Security Income shut out many disabled and low-income Americans from 
participation in potentially lifesaving clinical trials. That is 
because, in accordance with current ethical standards, many clinical 
trials offer modest compensation for patient participation, which can 
average around $500. Low-income patients with rare diseases face a 
serious barrier to taking part in drug trials, as the modest fee they 
receive for participation counts towards their eligibility for 
Supplemental Security Income and Medicaid and can push their income 
above the established caps. This forces patients to choose between 
receiving the essential benefits they need to live and the opportunity 
to participate in a clinical trial that could improve their condition 
and offer hope for a cure. This is a cruel choice that no one should 
have to make.
  The bill we are considering today addresses this situation by 
allowing Medicaid recipients and individuals who receive Supplemental 
Security Income to participate in clinical trials to provide 
compensation without the risk of losing their benefits, and by 
excluding up to $2,000 in compensation a patient receives from a 
clinical drug trial from

[[Page 16368]]

his or her income calculation for Supplemental Security Income and 
Medicaid eligibility.
  Our bill applies to rare disorders, which are defined as diseases 
affecting less than 200,000 people in the United States. There are more 
than 6,000 rare disorders that, taken together, affect approximately 25 
million Americans. Examples of rare diseases include ALS, Crohn's 
disease, cystic fibrosis, Huntington's disease and Parkinson's disease.
  The House version of this bill, which Mr. Stearns and I introduced 
more than a year ago, has 141 bipartisan cosponsors. The Senate version 
we are considering today, which included Medicaid eligibility in 
addition to SSI, passed the Senate by unanimous consent on August 5. 
The Congressional Budget Office has determined that the bill has no 
cost to the Federal Government. While there is no cost to the 
government, for millions of Americans the benefits could be enormous--
the chance to receive treatment that could dramatically improve their 
health.
  For scientific research, clinical drug trials are an essential part 
of the process for searching for treatments for diseases. When testing 
treatments for rare diseases in particular, researchers need patient 
participation from a significant percentage of patients with each 
disease in order to produce valid results. Consequently, researchers 
often struggle to recruit enough patients.

                              {time}  1130

  Today, we are working to eliminate one of those barriers to 
participation by opening clinical trials for rare diseases to those on 
Medicaid and Supplemental Security Income.
  This could produce dramatic advancements towards a cure for rare 
disorders, including cystic fibrosis. There are approximately 30,000 
people living in the United States with cystic fibrosis today. In the 
1950s, children with CF usually didn't live past the age of 
kindergarten. Now, CF patients live productive lives with a median age 
of 37, thanks to advances in medical research just over the last 40 
years.
  More than 30 potential therapies are in the CF drug development 
pipeline today, more than in the entire history of CF research, and 
many are being tested in clinical trials.
  In the next 2 to 3 years, we will need more than 7,000 CF patients to 
participate in clinical drug trials. Three thousand CF patients 
participated in drug trials last year. Nearly 50 percent of the CF 
population receives public benefits, including SSI and Medicaid.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. McDERMOTT. Mr. Speaker, I yield the gentleman an additional 2 
minutes.
  Mr. MARKEY of Massachusetts. Listen to that again: Nearly 50 percent 
of the CF population receives public benefits, including SSI and 
Medicaid.
  While the average clinical trial compensation amount for a cystic 
fibrosis drug is $700, an individual with cystic fibrosis often has 
medical expenses totaling nearly $80,000 per year. Clinical research is 
critical to our progress towards curing rare diseases such as cystic 
fibrosis, especially at a time of tremendous opportunity and hope in 
medical research.
  The bipartisan Improving Access to Clinical Trials Act will encourage 
patients suffering from rare diseases to participate in promising 
clinical research that may lead to cures, better treatment, and 
ultimately, saved lives, without having to worry that they could lose 
SSI benefits.
  Our bill has been endorsed by more than 120 organizations, including 
the Cystic Fibrosis Foundation, the Biotechnology Industry 
Organization, the National Health Council, and Research!America.
  Research is medicine's field of dreams from which we harvest the 
findings that give hope to millions of Americans that the disease that 
runs through their family's history may finally be cured. That is what 
this bill is all about, ensuring clinical trials are conducted that 
give families hope.
  Again, I want to thank the gentleman from Florida and the leaders of 
the Ways and Means Committee for all of the work that you have done in 
making this a possibility. I urge an ``aye'' vote.
  Mr. BOUSTANY. Mr. Speaker, I am pleased to yield such time as he may 
consume to the gentleman from Florida (Mr. Stearns), one of the 
coauthors of the House bill.
  Mr. STEARNS. Mr. Speaker, I thank my colleague from Louisiana for 
yielding me this time.
  Obviously as a cosponsor in working with Mr. Markey, this is a very 
important bill. Mr. Speaker, this is bipartisanship in its essence. We 
have seen a lot of complaints both in the press and from the public 
about Members of Congress not getting together. Here you have a 
gentleman from Massachusetts and a gentleman from Florida working to 
cosponsor and to pass this bill. It has overwhelming support by Members 
here in the House. I look forward to its passage, and I commend the 
gentleman from Massachusetts (Mr. Markey) for what he is doing. We are 
cochairs and cofounders. We cofounded the Cystic Fibrosis Caucus some 
time ago. We are working, doing the Lord's work here.
  Mr. Speaker, a lot of what has been said is also in my speech, and I 
don't necessarily want to reiterate it again. Simply put, this bill 
improves access to clinical trials. It will allow people with rare 
diseases like cystic fibrosis to participate in clinical trials that 
provide nominal compensation without, and this is the key part, without 
the risk of losing their health coverage. Senator Wyden sponsored the 
bill S. 1674, and Mr. Markey and I sponsored H.R. 2866.
  I think all of us realize clinical trials are an essential part of 
the process as researchers develop new treatments for diseases. When 
testing treatments for rare diseases in particular, researchers need a 
significant percent of the patient population for each disease to 
participate in the various trials. Because of this, they often struggle 
to recruit patients. They just can't find enough.
  For example, let's go to the University of Alabama at Birmingham. It 
houses one of the Cystic Fibrosis Foundation's largest CF care centers 
with over 450 patients. The University of Alabama at Birmingham 
conducts numerous clinical trials on promising new treatments for CF 
patients. But when they began looking for CF patients to participate in 
trials for a new drug that some believe would be a game changer in the 
treatment of CF, they were only able to find four patients who met the 
trial protocol criteria. With these small numbers, the integrity of the 
study can be compromised if patients are not enrolled promptly. 
Enrollment becomes further compromised when patients choose to not 
participate because their Medicaid and SSI eligibility becomes at 
stake.
  We have come a long way in treating CF. In the 1950s, children with 
CF usually didn't last past the age of kindergarten. Now, with all of 
the advances in medical research, we can proudly say that CF patients 
live much longer and have more productive lives, with the median age of 
37. This is thanks in part to clinical trials which have brought 
effective new drug therapies to those with cystic fibrosis.
  So in the next 2 to 3 years, we will need more than 7,000 CF patients 
to participate in clinical drug trials. Three thousand CF patients 
participated in trials last year. The bill we have here on the floor 
will help new therapies move quickly from the laboratory into the hands 
of the patients who need them and will reduce the administrative cost 
of disenrolling a beneficiary from SSI and Medicaid one month and 
reenrolling the beneficiary the very next month.
  Importantly, the Congressional Budget Office has determined that this 
bill has very low real cost to the Federal Government, if none. So I 
ask my colleagues to join me in passage of this bill. As pointed out, 
we have over 120 cosponsors. The Association of Clinical Research 
Organizations has endorsed it, the Biotechnology Industry Organization, 
Cystic Fibrosis Foundation, Genetic Alliance, National Health Council, 
the National Organization of Rare Disorders, PhRMA, and 
Research!America.
  Passage of this bill is a long time in coming. It will improve 
Americans'

[[Page 16369]]

lives. As pointed out, it has no real cost. It is a simple fix to a 
current law that will save lives today. I urge its passage.
  Mr. Speaker, I rise today in strong support of S. 1674--the Improving 
Access to Clinical Trials Act, or the I-ACT.
  As the lead Republican sponsor of the original House version of this 
bill, H.R. 2866, I am so pleased we are taking up the companion to our 
bill that has already passed the Senate under unanimous consent. 
Passage of this bill in the House today will allow this important 
clinical trials legislation to be signed into law.
  I am a proud co-chair and founder of the Congressional Cystic 
Fibrosis Caucus, along with my friend and colleague from Massachusetts, 
Mr. Ed Markey. Through our work with the CF Caucus and the Cystic 
Fibrosis Foundation, we discovered that low income patients with rare 
diseases, such as cystic fibrosis, face a serious barrier to taking 
part in potentially lifesaving clinical trials, as the modest fee they 
receive for participating in a trial counts toward their eligibility 
for public health benefits such as Supplemental Security Income, SSI, 
and Medicaid. This actually forces patients to choose between receiving 
essential health benefits and the chance to participate in a clinical 
trial that could improve their condition. This is cruel choice no one 
should have to make.
  Today there are approximately 30,000 people living in the U.S. with 
cystic fibrosis, and unfortunately almost half of the CF population 
receives public benefits, such as SSI and Medicaid. However, there are 
also over 30 new drug therapies and treatments for CF in the pipeline, 
more than in the entire history of CF research, that can improve the 
health and lives of CF patients and potentially lead us to a cure. 
Unfortunately, however, because CF is a rare disease, there just aren't 
enough CF patients who can participate in clinical trials because they 
are afraid of losing their public health benefits.
  Our bill, the Improving Access to Clinical Trials Act, S.1674/H.R. 
2866, will simply allow people with rare diseases like cystic fibrosis 
to participate in clinical trials that provide nominal compensation 
without the risk of losing their health care coverage.
  Mr. Speaker, clinical trials are an essential part of the process as 
researchers develop treatments for diseases. When testing treatments 
for rare diseases in particular, researchers need a significant percent 
of the patient population for each disease to participate in these 
trials. And because of this, they often struggle to recruit enough 
participants.
  For example, the University of Alabama at Birmingham houses one of 
the Cystic Fibrosis Foundation's largest CF care centers with over 450 
patients. UAB conducts numerous clinical trials on promising new 
treatments for CF patients, but when they began looking for CF patients 
to participate in a clinical trial for a new drug that some believe 
could be a game changer in the treatment of CF, they were only able to 
find 4 patients who met the trial protocol criteria. With these small 
numbers, the integrity of the study can be compromised if patients are 
not enrolled promptly. Enrollment becomes further compromised when 
patients choose to not participate because their SSI and Medicaid 
eligibility is at stake.
  Mr. Speaker, we have come a long in treating CF. In the 1950's, 
children with CF usually didn't live past the age of kindergarten. Now, 
with all the advances in medical research, we can proudly say that CF 
patients live much longer and more productive lives, with a median age 
of 37. This is thanks in part to clinical trials that have brought 
effective new drug therapies to those with cystic fibrosis.
  In the next 2-3 years, we will need more than 7,000 CF patients to 
participate in clinical drug trials. Three thousand CF patients 
participated in trials last year.
  The I-ACT will help new therapies move quickly from the laboratory 
into the hands of the patients who need them and will also actually 
reduce the administrative costs of disenrolling a beneficiary from SSI 
and Medicaid one month and re-enrolling the beneficiary the next month. 
Importantly, the Congressional Budget Office has also determined that 
S. 1674 has no real costs to the Federal Government.
  I ask my colleagues to join me in supporting S.1674--the Improving 
Access to Clinical Trials Act. The House version of this legislation 
enjoys strong bipartisan support, with 141 bipartisan cosponsors. And 
the Senate bill passed under unanimous consent on August 5, 2010.
  Our bill has also been endorsed by over 120 organizations including: 
the Association of Clinical Research Organizations, the Biotechnology 
Industry Organization, the Cystic Fibrosis Foundation, Genetic 
Alliance, National Health Council, the National Organization of Rare 
Disorders, NORD, PhRMA, and Research!America.
  Passage of this bill today will go a long way toward improving the 
lives of Americans with rare diseases, and to bringing us even closer 
to a cure for rare diseases. This legislation also has no real costs to 
the Federal Government. It's a simple fix to current law that will save 
lives, and I am proud to support this bill and be its lead Republican 
sponsor in the House.
  Mr. McDERMOTT. Mr. Speaker, I have no further requests for time, and 
I reserve the balance of my time.
  Mr. BOUSTANY. Mr. Speaker, I am pleased to yield 3 minutes to the 
gentleman from Louisiana (Mr. Fleming), a physician who knows a little 
bit about clinical trials.
  Mr. FLEMING. I thank the gentleman from Louisiana for yielding me 
this time.
  Mr. Speaker, I have two special investments in this bill, Improving 
Access to Clinical Trials Act. One is being a physician, a family 
physician for 34 years. The other is that I have a grandson who was 
born with cystic fibrosis almost a year to the day. He was born 
essentially clinically dead. His bowels, his colon had ruptured in 
utero as a result of his cystic fibrosis. He was delivered. It was an 
emergency delivery. He spent the first two months of his life in the 
NICU. Several times we thought we would lose him. He has had a rocky 
course since then. Today, as a child of a year old, he is catching up 
with all of his developmental milestones. His health is good, 
relatively speaking. And he is a beautiful young blessing to my family. 
He still has a very rocky course.
  We know some of the statistics having to do with cystic fibrosis. 
There are approximately 30,000 people today with this disease. In the 
1950s, children rarely lived beyond kindergarten with this disease. 
Today, the average age is 37. We see people even in their sixties with 
cystic fibrosis. More than 30 percent of the potential therapies that 
we have are in the CF drug development pipeline today, many wonderful 
therapies. We can even see over the horizon that we may some day have a 
cure within our lifetime.

                              {time}  1140

  In the next 2 to 3 years, we will need more than 7,000 cystic 
fibrosis patients to participate in the clinical trials. So this 
problem that we have today with the fact that reimbursement from these 
clinical trials can ratchet down on one's SSI payments or Medicaid or 
Medicare is, of course, I think, a real impediment, a real blocking 
stone, for developments and strategies and therapies that we have for 
our clinical trials.
  Again, Mr. Speaker, I stand with my colleagues today on both sides of 
the aisle for this very bipartisan bill that we support, the Improving 
Access to Clinical Trials Act, and I urge each and every one of my 
colleagues to vote in favor of it.
  Mr. McDERMOTT. Mr. Speaker, I reserve the balance of my time.
  Mr. BOUSTANY. I am prepared to close.
  Mr. Speaker, I just want to say that I am glad we can work together 
on this bipartisan bill. It is an important step in improving access to 
clinical trials.
  I thank my colleague from Louisiana for sharing his personal story. 
It is a very poignant story, and it highlights the importance of this 
small step that we are taking to improve access to clinical trials.
  Mr. KLEIN of Florida. Mr. Speaker, I rise today in strong support of 
the ``Improving Access to Clinical Trials Act.'' I am a proud cosponsor 
of the House version because it will finally tear down an unnecessary 
barrier to clinical trials for people with life-threatening rare 
diseases like cystic fibrosis.
  Under current law, patients with rare diseases face an unconscionable 
choice. If you are receiving Supplemental Security Income benefits, 
then you could potentially lose these benefits if you participate in a 
clinical trial. That's because many clinical trials offer compensation 
in accordance to ethical guidelines in exchange for your participation. 
This compensation can put you over the income requirements for the SSI 
program. So in effect, the choice becomes this: take a chance on a cure 
for tomorrow, or risk losing the critical support you depend on today. 
That's no choice that anyone should ever have to make.

[[Page 16370]]

  The ``Improving Access to Clinical Trials Act'' removes this barrier 
by exempting the income from a clinical trial from the SSI threshold, 
thus freeing people to participate if they so choose. It's a common-
sense fix that is long overdue and will help groundbreaking research 
into the cures of tomorrow for rare diseases.
  I am also proud to support this legislation because one of my 
personal missions is to support research to fmd a cure for cystic 
fibrosis. Long before I ever came to Congress, my wife, Dori, and I 
supported the Cystic Fibrosis Foundation because of our close 
connection to people with this rare disease. Andrea Levy, from my 
hometown of Boca Raton, is one such person.
  At the age of six, Andrea was diagnosed with cystic fibrosis. She has 
fought this disease with courage, and volunteers her time as an 
advocate for others that face similar health challenges. After 
graduating from the University of Florida with honors, she earned a 
masters' degree and is now working full-time as a counselor at a local 
school so she can continue to help others and give back to our 
community. Yet every day, she has to set aside hours for treatment and 
therapy to fight her disease. Andrea and the many others like her with 
CF should be able to live the American Dream without the burdens of a 
genetic disease. Yet this quirk in SSI law prevents more clinical 
trials from going forward because of a lack of people who will sign up.
  It's for Andrea and all the people with rare diseases that I have 
pushed not only for greater access to clinical trials, but for greater 
investments in biomedical research. I am a longtime supporter of both 
the National Institutes of Health and private sector organizations such 
as The Scripps Research Institute and the Max Plank Institute. Finding 
cures to diseases that afflict so many must remain a fundamental goal 
of both the public and private sector. On this point, I will not waver.
  Let me close by saying that the passage of this important legislation 
is a shining example of how this body should work. We have strong 
bipartisan support in both the House and the Senate. My good friend 
from Florida, Mr. Stearns, has been a champion for cystic fibrosis and 
this legislation on the Republican side. I am proud to stand with him 
today and encourage our colleagues to support this important 
legislation and for President Obama to sign it into law.
  Mr. MARKEY of Massachusetts. Mr. Speaker, many years ago, I had the 
good fortune to meet Joey O'Donnell. Joey was the son of my close 
friend from Malden, Massachusetts, Joe O'Donnell. Joey was a brave and 
resilient child despite suffering from Cystic Fibrosis, CF, a cruel 
disorder that robs the body of the ability to breathe normally and 
leads to other debilitating health problems. As a result, CF typically 
cuts lives tragically short.
  In 1986, Joey passed away when he was only 12-years-old. Because of 
Joey and the tireless work of his father Joe and mother Kathy, who 
encouraged me to intensify Government efforts to combat CF, I decided 
to found the Bi-Partisan Cystic Fibrosis Caucus in Congress. Our goal 
has been to raise awareness and build momentum towards a cure for CF, 
ALS, Parkinson's, Huntington's and other rare disorders.
  I was pleased to partner with my colleague, Representative Cliff 
Stearns (R-FL), in passing the Improving Access to Clinical Trials Act 
and sending it to the White House to be signed into law. This bill will 
open up participation in clinical trials for diseases like CF to low-
income and other patients. The bill excludes from the income caps set 
for the Supplemental Security Income and Medicaid programs the 
compensation that these patients receive for their participation in 
clinical trials for rare diseases The legislation will ensure that this 
modest compensation will not affect eligibility for these programs.
  Patients will no longer have to choose between their health benefits 
and the promise of a clinical trial. If we want to increase the chances 
of finding cures to diseases like Cystic Fibrosis, we also need to 
increase participation in these trials. The Improving Access to 
Clinical Trials Act gives low-income individuals a higher probability 
to help advance medical science, and helps save lives in the process, 
hopefully including their own.
  The bill we passed and the law that President Obama will enact with 
his signature is really ``Joey O'Donnell's Law''. He inspired it, and 
his name will forever be associated with it. Joey died before his time, 
but his impact will be timeless. I salute my friend Joe O'Donnell and 
his wife Kathy and send my best wishes to the entire O'Donnell family. 
I also want to recognize my friend Bob Coughlin, President and CEO of 
the Massachusetts Biotechnology Council, for his tireless work to help 
find cures to CF and other rare disorders. This new law will offer hope 
to families around the country and bring us closer to the day when we 
consign these devastating diseases to the history books.
  Mr. BOUSTANY. Mr. Speaker, I yield back the balance of my time.
  Mr. McDERMOTT. Mr. Speaker, this is sort of an historic moment. If 
you can get three doctors to agree on the same thing on the floor of 
the House of Representatives, you've got a pretty good bill.
  I urge passage of the bill, and I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Washington (Mr. McDermott) that the House suspend the 
rules and pass the bill, S. 1674.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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