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.

Mr. President, I am pleased today to join my colleague, Senator Murkowski, in introducing legislation that would give Alaska Native Corporation, ANC, parity for an important tax incentive encouraging the permanent protection of land through the charitable donation of a conservation easement. I would also like to commend our colleague Congressman Don Young, who today introduces a companion bill in the House of Representatives.

America's wildlife, waters, and land are an invaluable part of our Nation's heritage. It is imperative to preserve these natural treasures for future generations. Congress long ago concluded that it was good public policy to encourage the charitable contribution of conservation easements to organizations dedicated to maintaining natural habitats or open spaces help protect the nation's heritage. A conservation easement creates a legally enforceable land preservation agreement between a willing landowner and another organization. The purpose of a conservation easement is to protect permanently land from certain forms of development or use. The property that is the subject to the easement remains the private property of the landowner. The organization holding the easement must monitor future uses of the land to ensure compliance with the terms of the easement and to enforce the terms if a violation occurs.

In 2006, Congress enhanced the charitable tax deduction for conservation easements in order to encourage such gifts. With the 2006 legislation, Congress temporarily increased the maximum deduction limit for individuals donating qualified conservation easements from 30 percent to 50 percent of the taxpayer's adjusted gross income. Congress also created an exception for qualified farmers or ranchers, which are non-publicly traded corporations or individuals whose gross income from the trade or business of farming is greater than 50 percent of the taxpayer's gross income. In the case of a qualified farmer or rancher, the limitation increased from 30 percent to 100 percent. The 2008 Farm Bill extended the temporary rules for two additional years to charitable contributions made before December 31, 2009.

Unfortunately, the way the law was crafted has disadvantaged a number of important landowners in my home state. Alaska Native Corporations, ANCs, own nearly 90 percent of the private land in Alaska, including some of the most scenic and resource rich. However, although they are very similar to the small communal family farms that are eligible, subsistence-based Alaskan Native communities are ineligible for these important new tax incentives. For thousands of years, Alaska has been home to Native communities, whose rich heritages, languages, and traditions have thrived in the region's unique landscape. Members of Alaska Native communities continue to have a deeply symbiotic relationship with the land even today. Much like their ancestors, many Native Alaskan communities engage in

traditional subsistence activities, with nearly 70 percent of their food coming from the land or adjacent waters. For many communities, subsistence is an economic necessity considering both the lack of economic development and the cost and difficulty involved in purchasing food. For example, in Kotzebue, a community in Northwestern Alaska, milk costs nearly $10 per gallon. In Buckland, a village home to approximately 400 people, a pound of hamburger, when it is actually available, costs $14.00.

In Alaska, the Native Corporations have an important role to be stewards of the land. Their shareholders see themselves as the caretakers of the land and water as their ancestors have for thousands of years. Nonetheless, in Alaska today this means they have to balance the need for resource development and the need to cultivate the land for subsistence activities. The traditional lifestyles of Native Alaskans are under increasing stress from outside influences. Population growth and the pressure to pursue cash-generating activities have increased the desire for substantial development, significantly adding to the ecological stress on already fragile ecosystems. Without permanent protection, their lands could be developed in a manner that would destroy its ability to support the traditional ways and subsistence lifestyles crucial to Alaskan Native communities. Making use of tax incentives available to other Americans will make it easier for Native communities to make the right decisions for their shareholders.

Today, Alaska Native communities are not eligible for the 50 percent deduction available to individuals because they are federally chartered as C corporations under the Alaska Native Claims Settlement Act of 1971, ANCSA. This leaves Alaska Natives without the ability to convert to an eligible entity as other landowners can. In addition, most Alaska Native Corporations do not have sufficient gross income from the trade or business of what is considered traditional farming to be eligible for the 100 percent deduction available to qualified farmers or ranchers. This is in spite of the fact that as a group the Alaska Native shareholders of Alaska Native Corporations receive far more in subsistence benefits than they receive in income from the Alaska Native Corporation. As a result, Alaska Native Corporations do not have the same ability to offset the cost to permanently protect their properties, which contain important wildlife, fish, and other habitats, through donations of qualified conservation easements.

The bill I am introducing with Senator Murkowski will allow Alaska Native Corporations to protect these important wildlife habitats, many used for subsistence, by providing an enhanced deduction for qualified conservation easements. The legislation modifies Section 170(b)(2) of the Internal Revenue Code by creating a new subsection that provides Alaska Native Corporations with a deduction for donations of certain qualified conservation easements. In order to be eligible, a qualified charitable conservation contribution must: (1) otherwise qualify under Section 170(h)(1); (2) be made by a Native Corporation; and (3) be land that was conveyed by ANCSA. Under Section 170(b)(2)(iii)(I), ``Native Corporation'' is defined by ANCSA, section 3(m). Under Section 170(b)(2)(i), the maximum deduction limit would be set at 100 percent of the taxpayer's adjusted gross income. If the taxpayer has deductions in excess of the applicable percentage-of-income limitation, Section 170(b)(2)(ii) would allow the taxpayer to carry-forward the deduction for up to 15 years.

Congress must act to assist Alaska Native communities in permanently protecting their culturally, historically, and ecologically significant land, preserving the communities and their rich traditions in the process. I urge my colleagues to support this important legislation.

Mr. President, during the past decade we have witnessed tremendous development in the way video content is made available to consumers. Today, as a result of digital technology, we can watch movies, television programs, and other video not only on our television sets, but also on our computers, phones, and other mobile devices. In order to maximize the potential of digital content, Congress must ensure that our copyright and communications laws are modernized and updated to accommodate the digital revolution. Today, I join with Senators Sessions, Kohl, Hatch, and Kyl in introducing the Satellite Television Modernization Act of 2009. Our legislation will reauthorize, modernize, and simplify important portions of the statutory license used by satellite providers that will otherwise expire at the end of this year.

The transition to digital television requires Congress to modernize the statutory copyright licenses that allow cable and satellite providers to retransmit the content of local broadcast stations. In February, many stations across the country, including those in Vermont, made the digital transition and can now offer multiple programming channels over a single, crystal-clear digital signal. In June, the remaining broadcast stations across the country completed the digital transition. The current statutory licenses, however, are based on the now outdated analog standard. In our reauthorization, we seek to ensure that the licenses work properly in the digital world.

In June 2008, the U.S. Copyright Office issued a report on the statutory licenses, and offered recommendations on how to improve the current system. The Copyright Office's principal recommendation was to move toward abolishing the compulsory licenses, in particular the distant signal licenses. Short of that, the Copyright Office offered suggestions on how to harmonize and streamline the licenses.

The legislation we introduce today draws on the recommendations of the Copyright Office and takes important steps toward limiting future reliance on the section 119 distant signal license used by satellite providers. This legislation will move locally oriented elements out of the distant signal license--such as the special exception that allows Vermonters in the State's southern-most counties to receive Vermont broadcast stations by satellite--and place them into the section 122 license, which facilitates the retransmission of local content with the consent of the broadcaster. The bill will also fix an anomaly in the distant signal license, which will make it easier for satellite providers to serve local markets that are missing a network affiliate.

Making these changes will improve the ability of satellite providers to deliver a full complement of network stations to consumers, as well as make it easier for them to offer local stations. In Vermont, these changes will have the additional benefit of fostering competition between DISH Network and DirecTV, by allowing DISH to offer Vermont broadcast stations in southern Vermont, a service DirecTV provides today. The legislation also adds a new provision to the local license that will allow satellite providers such as DISH to import a missing network station from an adjacent market when the local market is not served by all four principle networks, after the provider first obtains the station's consent. This new provision will make it more likely and reasonable for DISH to launch local service in these markets, which is good for local broadcasters, good for satellite providers, and good for consumers.

These changes will not only improve the satellite licenses, but will begin the process of phasing out the distant signal license as satellite providers offer local service in more markets. As the distant signal license fades, Congress should follow the Copyright Office's suggestion and move ultimately toward a market-based system, in which statutory licenses are unnecessary.

One further step we can take toward a marketplace model this year is to allow broadcast stations to opt-out of the statutory licenses. All non-broadcast channels carried by cable and satellite providers, such as ESPN and the USA Network, are able to aggregate a complex series of content rights, and negotiate for carriage in the free market. Local broadcasters should be permitted to do the same if they, too, are able to aggregate the necessary rights to license directly to cable and satellite providers. This is a proposal I expect the Judiciary Committee to examine as the bill moves through the mark up process. I encourage all industry participants to work with the Committee so that we can address any concerns about this market-based approach.

Short of repealing the compulsory licenses, the Copyright Office recommended harmonizing the cable and satellite licenses in order to create regulatory parity between the two industries. The section 111 license used by cable, for instance, is based on FCC rules that have long since been repealed, and the license itself has not been significantly updated since it was established more than 30 years ago. The arcane nature of the cable license can at times produce unintended results, such as cable companies paying copyright holders for content that consumers do not actually receive. This is referred to as the phantom signal problem. In contrast, satellite companies pay a flat, per subscriber rate based on consumers actually receiving a broadcast station. Comprehensive reforms to section 111 that aim to modernize the statute and create regulatory parity between cable and satellite providers would address these disparities. We take a more modest approach in the bill we introduce today. The legislation contains an amendment that will resolve the phantom signal issue. I appreciate that members of the content community and the cable system came together to find a solution on which they can all agree.

The Satellite Television Modernization Act is one component of the reauthorization. Portions of the expiring law are within the jurisdiction of the Senate Committee on Commerce, and I look forward to working with the leadership of that Committee, and our counterparts in the House of Representatives, to enact legislation that once again improves the law by fostering competition, protecting broadcasters, and improving service to consumers.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

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.