Improving Access to Clinical Trials Act of 2009

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

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.

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.

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.

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. 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.

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.

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.

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. Speaker, I yield 5 minutes to the gentleman from Massachusetts (Mr. Markey).

Mr. Speaker, I yield the gentleman an additional 2 minutes.

Mr. Speaker, I have no further requests for time, and I reserve the balance of my time.

Mr. Speaker, I reserve the balance of my time.

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.

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. 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. 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.

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. Speaker, I yield back the balance of my time.

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.