Jared Polis

Mr. POLIS

Mr. POLIS. Mr. Chairman, I have an amendment at the desk.

Mr. POLIS. Mr. Chairman, I would like to start by commending Chairman Upton, Ranking Member Pallone, Ms. DeGette, Mr. Green, and so many others. I am proud to join as a cosponsor for the 21st Century Cures Act, which is really a first step to updating our approval process to help countless Americans gain access to lifesaving drugs and devices. This bill will save lives. I am proud to support it and send a strong message that we need to move forward with reform. But at the same time we are passing this bill, we should start thinking about what the next step is. Passage of this bill should not foreclose additional opportunities in the future to improve access to lifesaving medical device products and lifesaving drugs. Most importantly, this body can move forward with the next generation and start the process to help people get access to medical technology that can help keep people healthy, independent, save lives, and save money. It is in that spirit that I put forward my amendment, which would look at a two-tiered approval process for medical devices, that would allow devices to come to market once they have demonstrated safety while the FDA is still reviewing them for efficacy. This solves a real problem in the world. In the U.S., the cost of bringing a medical device to market through the approval process is $30 million to $100 million. Those are costs that are then added to consumers of the medical device. That makes it even more difficult for niche medical devices that may help rare and unusual conditions because they are priced prohibitively. In addition, there is the aspect of the timeline. In the European market, for instance, if somebody creates a new device to prevent blood clots, it reaches the market in 7 to 11 months. In the U.S. market, they are looking at a timeline of 2\1/2\ to 4 years. Think of how many sufferers might die or have additional health problems simply because our own government is keeping that lifesaving product off the market, even though it has been demonstrated as safe. An additional result is that some medical technology companies are bypassing the U.S. market altogether when they develop new devices, which can result in years-long delays for access to U.S. patients and, in some cases, companies who view the U.S. approval system as too expensive market their devices exclusively in other nations. I think it is important to talk about what comes next. I think that with both devices and drugs, we need to look at the potential for a two-tiered process that allows a provisional approval and access to the U.S. market. That doesn't mean that insurance will cover it. That doesn't mean, clearly, that they can make any health claims with regard to the efficacy of their product. That is in existing law. But with regard to the safety being demonstrated, the provisional marketing of the product in America can save lives and will save lives. I reserve the balance of my time.

Mr. POLIS. Mr. Chairman, I thank both the chair and the ranking member. This is a very important discussion to have, both with regard to devices and also with regard to drugs. We know that there are treatments that are available overseas. I represent a district with, by the way, one of the largest veterinary hospitals in our country, Colorado State University Veterinary Teaching Hospital, and I can tell you that there are actually treatments, advance treatments available today for animals with cancer, like horses, that are not yet approved for humans and are lifesaving. If we can provide access in a shortened timeframe--I understand that while medical devices might cost $30 million to $100 million to bring to market, drugs often cost over $1 billion to bring to market. There are additional opportunities, by the way, in making sure that, as part of this provisional process, at least with regard to drugs, the data can be gathered, too. So it can serve a dual function and might, at the same time complying with some of the needs or an updating of the needs of some of the phases of FDA efficacy trials, it can actually be available through a market-oriented plan where people, consumers who are fully informed and, of course, to whom no health claims have been made, can choose to purchase the product, just as they can today, by the way, but they have to buy it overseas and import it for their own personal use. I have constituents who do that. But I think we can facilitate that process. I deeply appreciate working with the chair and the ranking member of the committee and the subcommittee with regard to helping to bring access to lifesaving medical devices and pharmaceutical products to our shore.

Mr. POLIS. I yield to the gentleman from Pennsylvania.

Mr. POLIS. Mr. Chairman, I ask unanimous consent to withdraw my amendment.

Mr. POLIS

Mr. POLIS. Mr. Chairman, I would like to inquire as to how much time remains on both sides.

Mr. POLIS. Mr. Chairman, I yield 1 minute to the gentlewoman from Massachusetts (Ms. Tsongas).

Mr. POLIS. Mr. Chairman, I have many of my constituents who are living in holdings on Federal lands. What happens if Federal land management policy changes their rights-of-way and makes it harder to access where they live? Where are they supposed to come up with the hundreds of thousands or millions of dollars that it would take to bond under this scenario to figure out whether what the Federal Government did was legal or not? That is why we need to fix this, Mr. Chairman. And I urge my colleagues to support my amendment to defend the constitutional rights of families who live in and around Federal land. I yield back the balance of my time.

Mr. POLIS. Mr. Chairman, I demand a recorded vote.

Mr. POLIS. Mr. Chairman, my amendment would strike a harmful and politically driven provision on the underlying bill that has the effect of limiting stakeholder input and curbing equal access to justice, a core constitutional principle in our Republic, and effectively removes an important check we have on arbitrary actions by Presidents and administrations. Absent my language, the underlying bill would hand President Obama a blank slate in determining how we run our Western lands. My bill will restore that balance and allow civil society stakeholders and local residents to be able to challenge illegal Federal actions. While I respect and appreciate the impetus for many parts of this bill and support them, particularly those aimed at incentivizing collaborative development management plans and fixing the flawed funding structure for wildfire response--very, very important in my district--the provision that I am striking in my amendment is truly a poison pill for many on my side of the aisle who care deeply about equal access to justice and many on the other side of the aisle who don't want to hand President Obama an unchecked control over Federal lands. In districts like mine, which are made up of 62 percent Federal land, the Forest Service owns huge amounts of open space that we use, enjoy, is a driver of our tourism economy; we recreate as hikers, skiers, hunters, bikers; it is used commercially by loggers, utility providers, and many, many other groups. I can attest to the fact that these groups, these stakeholders that I mentioned whose livelihood and enjoyment depend on these lands, are extremely valuable when it comes to providing practical, varied input into managing our Federal lands. This bill, however, would discourage and limit the depth and diversity of public input by expediting the development of forest management plans while removing the legal venues that exist for protest after a management plan has been implemented, meaning not only does the provision, like the one I am trying to strike, cripple the transparency and effectiveness by limiting the form of expertise we have in planning our Federal lands, it also has the potential to repeal some critical rights, like the right to protest and legal recourse for potential wrongdoing. The provisions I move to strike would effectively eliminate the ability of citizens, nonprofits, local residents, independent advocacy organizations, and others to file lawsuits against potentially illegal or improper forest management tools that the executive branch is using. By creating a harmful bonding requirement, which would really exclude judicial access for everybody--except the very wealthiest corporations and people--and a prejudicial fee-shifting requirement that enables the government to act with impunity at the clear expense of the plaintiff, we really break down the core principle of equal access to justice, which is our right. By prohibiting the courts from issuing any restraining orders, preliminary injunctions, or injunctions pending repeal in cases of postdisaster operations after broadly defined events, we are only compounding the damage. Again, Mr. Chairman, my colleagues on the other side of the aisle's move to block the court's ability to make sound, thoughtful, and transparent decisions if the executive branch acts illegally really will come at the expense of our local stakeholders for those of us who live in and around Federal land. Mr. Chairman, I reserve the balance of my time.

Mr. POLIS. Mr. Chairman, I have an amendment at the desk.

Mr. POLIS

Mr. POLIS. Mr. Chairman, the gentlewoman from Utah talked about decisions and implementation at the local level. On that, we agree. What this amendment is about is accountability metrics under whether we look at those decisions that are made locally and driven locally and by the State work or don't work. We want to allow the flexibility to get things right and close the achievement gap but not the flexibility to continue to ignore persistent gaps in our education system that continue to poorly serve too many low-income students and minority students. Given that my amendment is included in its entirety in the Democratic substitute upon which we will be voting, I ask unanimous consent to withdraw my amendment.

Mr. POLIS. Mr. Chair, I would like to inquire as to how much time remains.

Mr. POLIS. Mr. Chairman, I have an amendment at the desk.

Mr. POLIS. Mr. Chairman, No Child Left Behind's metrics are outdated and rigid. On that we agree. But H.R. 5 in its current form abandons provisions that are crucial to ensuring equal educational opportunities for all of our Nation's students. My amendment advances a more comprehensive and effective vision of accountability at the school district and State levels. This new language expects States to set college- and career-ready standards rather than to allow them to dumb down their standards in order to inflate their results. It also requires States to set performance growth and graduation rate targets that ensure that schools improve every year for all subgroups, including for students with disabilities. One of the major deficiencies in H.R. 5 and one of the reasons that all of the advocacy groups for students with learning disabilities oppose the bill is it effectively removes the accountability we have for students with disabilities to ensure that they continue to learn. There is currently a 1 percent cap on the students with the most severe disabilities who are not tested. H.R. 5 would eliminate the 1 percent cap on alternative assessments based on alternative achievement standards and would remove it altogether, allowing, ultimately, schools and States to decide not to have any accountability for those students who need programs that meet their learning needs the most. The Democratic substitute amendment upholds our Nation's civil rights and equity responsibilities to ensure that all students receive a high- quality education. It reinstates the 1 percent cap on alternative assessments for students with disabilities. It makes sure that accountability is a meaningful word and takes meaningful steps toward getting accountability right, rather than allowing discrimination and bad choices to continue to result in an increasing achievement gap across our country. This amendment is also reflected in the Democratic substitute and would make sure that we have an accountability system that prepares our students for the jobs and the workforce of the 21st century and to move on to higher education. Absent including this language or the Democratic substitute in the final passage of the bill, the bill in its current form would be a step backward, a step to lower standards, a step to reduce accountability, and a step to allow deficiencies to be swept under the rug, as they once were. I reserve the balance of my time.

Mr. POLIS. Mr. Chairman, I yield 1 minute to the gentleman from Virginia (Mr. Scott), the ranking member on the committee.

Mr. POLIS. I thank the ranking member. Mr. Chairman, one parent recently wrote me that she prefers that students with special needs be required to take tests. In her words, ``The tests gave us the data we needed to see where my son needed additional support.'' I rise in opposition to Mr. Salmon's amendment. Before No Child Left Behind was passed, schools across the country would systemically excluded students from tests in an effort to inflate a school's overall performance and sweep deficiencies and discrimination under the rug. This amendment, which would allow students to opt out of tests and allow those students to be omitted from the testing threshold, would make it easier to, once again, exclude historically marginalized students from accountability systems. There would be almost no way of knowing which students truly opted out, which were pushed out, and which students stayed at home at their schools' suggestion or traveled on an optional field trip. In my home State of Colorado, a similar provision was brought up in the State legislature, and over 400 business and community leaders strongly publicly opposed the bill and succeeded in defeating it. In order to close achievement gaps, we need data on every student, regardless of race, background, or disability. This kind of policy allows the very data we need the most on the most needy kids to be swept under the rug. For that reason, I strongly urge a ``no'' vote on this amendment.

Mr. POLIS. Mr. Chairman, of course you can look at a bill during its period of initial authorization. There are routinely cleanup bills that move through this body. And I wish--I wish--the No Child Left Behind had a cleanup bill in 2002 or in 2003 or in 2004, all during its initial period of authorization, but President Bush closed the doors on even the changes that I think that we could have had broad consensus that we needed to pass. But of course whatever comes out of this ESEA process, if we can agree on cleanup things and unintended consequences 2 years, 3 years out, let's do them. Look, the answer is not to move the ball. It leads to the spinning of the wheels for a period of years. And rather than working on educating kids, people are working on complying with an ever-changing matrix of Federal, State, and local law. There is a lot that happens after we pass a law in this body. It goes to Federal rulemaking, input from various constituencies, final rules. It goes to States who might change their policies, State Boards of Education, State commissioners. It goes down to districts, busy superintendents who are worried about bus schedules, who are worried about opening new schools, have to worry about recommending to their boards the new policies that will comply with our new Federal law. It takes a lot of time. It might take 2 years, 3 years before it finally reaches those policy implementation levels on the ground at a local level. And guess what, if this amendment becomes law and the authorization period is only 4 years, they might finally--finally-- start complying with this law only to find that there is a future Congress, a future President that moves the ball once again and starts the whole cycle of spinning wheels all over again. We need to make sure that whatever we do in this body, that we give time for a thoughtful implementation of it at the State and local level that doesn't detract from the core mission that the men and women who teach in our classrooms, the men and women who volunteer on school boards, the professionals who serve as superintendents commit their lives to in terms of educating kids. So we need to move forward with a longer reauthorization. If there are cleanup matters that we can agree on during that authorization period, we should by no means preclude them from the discussion until the end of this authorization. That was one of the problems with No Child Left Behind, that this body never had a follow-up discussion. I urge my colleagues to vote ``no,'' and I yield back the balance of my time.

Mr. POLIS. Mr. Chairman, to be clear, the gentleman was not yielded time from the gentleman from Virginia.

Mr. POLIS. Mr. Chairman, there is a great potential for cooperation between Democrats and Republicans, as has historically been, with regard to education; and that lies in, of course, enhancing flexibility in freeing teachers and principals and districts from some of the bureaucratic constraints that they have that distract from their ability to maximize education. But along with that increased flexibility needs to come accountability; otherwise, we wind up with the worst of both worlds. And just like No Child Left Behind erred too far in the direction of not enough flexibility with too much in the wrong kind of accountability, so, too, must we be careful not to err in the direction of too much flexibility without accountability. It is important to make sure that as we increase the ways and the manner that States and districts have to free up local innovation at the classroom level, at the school level, at the district level, we need to make sure and reiterate what our goals are here. How do we make sure that all students are learning? How do we make sure that schools are serving students with disabilities under IDEA? How do we make sure that districts and States are committed to closing the achievement gap between students of color and White students, even in local jurisdictions that might not have that political will intrinsically? That is the Federal promise. That is the promise and the reason behind ESEA and our efforts to improve education across these United States. To turn it over to the States effectively makes the referee a player on the field. We need to have an objective look. The same people who are concerned with deciding exactly how moneys are spent cannot objectively weigh whether it is working or whether it is not. That is just human nature. We need to make sure that if States have additional flexibility in grants--something I think that we can certainly work together on--if they have that flexibility, we need to make sure there is an objective standard under which what they are doing with that flexibility is determined to work or not to work. And if it doesn't work, we need to encourage those States to move in a different direction. If it does work, we can increase our efforts to support them. So again, there is a general premise here that can be worked on, but the underlying amendment would be extremely detrimental to public education.

Mr. POLIS. Mr. Chairman, I yield such time as he may consume to the gentleman from Virginia (Mr. Scott), the ranking member.

Mr. POLIS. Mr. Chairman, a point of parliamentary inquiry.

Mr. POLIS. Mr. Chairman, I claim the time in opposition.

Mr. POLIS. Mr. Chairman, I had the opportunity to serve on our State Board of Education in Colorado from 2001 to 2007, so this was during the implementation phase of No Child Left Behind. Now, we knew at the time many of the flaws we are hoping to address through ESEA reauthorization today, but it took several years just to get up to the point where we had the tests, we had the standards, and we complied with it. Education is a major public enterprise. In fact, it is the largest public enterprise at the State and local level. One of the frustrations that I have heard a lot of in the last few years--and it has really amplified the frustration about testing--is the fact that the ball has been moving, the testing has been changed. My State of Colorado, which is fairly typical, moved from one test, the CSAP, to a temporary test, the TCAP, and then finally a third test, all in a period of 4 years. What we need to do--and this is something that we will hear from education stakeholders as varied as teachers, school boards, and principals--is stop moving the ball. We know it is not going to be perfect. Let's give it a little bit of time to work. Now, this bill is far from perfect, which is why I oppose the underlying bill; but whatever set of rules you set in place, I feel it is important to allow the rulemaking, the State laws, to catch up, which takes a period of time, a period of years. I think the longer reauthorization, through 2021, rather than reducing it to 4 years, is absolutely in the interests of ensuring that whatever law we come up with can be implemented more effectively at the State and local level. Not only is it frustrating for districts and teachers to chase a constantly moving ball, it detracts from their most important effort, which is to educate the next generation of Americans. Mr. Chairman, I reserve the balance of my time.

Mr. POLIS

Mr. POLIS. Mr. Speaker, I yield 2 minutes to the gentleman from Texas (Mr. Doggett).