[Congressional Record Volume 156, Number 129 (Thursday, September 23, 2010)]
[House]
[Pages H6891-H6896]
From the Congressional Record Online through the 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.
[[Page H6892]]
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
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.
[[Page H6893]]
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 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.
[[Page H6894]]
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 asked and was given permission to revise and extend his
remarks.)
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' 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
[[Page H6895]]
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.
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. 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.
[[Page H6896]]
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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