Access to Medicare Data Act of 2007

Mr. President, today I am pleased to introduce the North Bay Water Reuse Program Act of 2007, together with my colleague Senator Boxer. This legislation authorizes Federal participation in a regional water reuse project that is the first of its kind in Northern California, and model for the West.

The program will allow urban water agencies to take treated wastewater now discharged into the sensitive bay-delta ecosystem and put it to productive use on water-short agricultural lands and environmentally valuable wetlands. It is an innovative ``win-win'' solution that will protect the environment as well as meet the future water needs of urban and agricultural

water users in the North Bay region of California.

Agricultural producers in the North Bay region are facing, and will continue to encounter, major water shortages. At the same time, as regulations continue to restrict and/or eliminate wastewater discharge, many communities in the North Bay region will face challenges as they try to determine the best way to discharge their treated wastewater.

The North Bay Water Reuse Program will address both problems and enhance the ecosystem of the San Francisco Bay. Specifically, the program will distribute reclaimed water through a conveyance system and deliver it to agricultural growers, promising a permanent and dedicated supply of about 30,000 acre-feet of water per year.

The use of reclaimed water for irrigation will reduce the demand on both surface and groundwater supplies, and thus improve instream flows for riparian habitat and fisheries recovery. Furthermore, in the off- season when irrigation demand is diminished, the reclaimed water will be used to increase surface water flows for the restoration of wetlands, creating habitat for migratory waterfowl and other wetland species.

Most notably, this program grew from a collaboration of the three major stakeholders in the region that vie for the same water. It is significant that the program is supported by the local governments in three counties, Napa, Sonoma and Marin Counties; agricultural organizations, such as the Napa and Sonoma County Farm Bureaus, the Carneros Quality Alliance, the Winegrape Growers of Napa County, the Napa Vintners Association, the North Bay Agriculture Alliance; and environmental organizations, such as The Bay Institute.

Thus, the North Bay Water Reuse Program brings stakeholders that are usually at odds with one another to the table to find a solution that is beneficial to all.

Finally, I would like to note the energy benefits of this project. The Sonoma Valley treatment plant, installing solar panels that will generate 40 percent of its energy needs. Another partner in the program, Las Gallinas Valley Sanitary District, generates 90 percent of its operating energy using solar panels.

The North Bay Water Reuse Program will allow vineyard managers to cease or significantly reduce their use of gas and electric powered pumps that currently deliver irrigation water. The program proponents expect to see a net reduction of overall energy use for regional irrigation operations, as well as a net reduction in the emissions of carbon dioxide from irrigation operations.

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

Mr. President, today I am introducing the Madera Water Supply Enhancement Act. This legislation authorizes the Bureau of Reclamation, Bureau, to participate in the design and construction of the Madera Water Supply Enhancement Project, project, that is essential to

improving the water supply in the Madera Irrigation District, MID, in Madera County, CA, and in California's Central Valley.

Representative George Radanovich has introduced companion legislation to this bill in the House, and I look forward to working with him to get this bill enacted.

Agriculture is a multibillion enterprise in California, which produces a significant portion of the Nation's food supply. To secure this food supply, water is essential. When constructed, the project will have the capacity to store up to 250,000 acre-feet of water and move up to 55,000 acre feet in or out of storage each year.

With increasing demands on limited water supply, the project will enable water users to store excess wet year water supply and this stored water can then be used during dry years to meet demand. To ensure the viability of the groundwater table and address overdraft problems, 10 percent of the water placed in storage would be left in the ground to replenish the aquifer over time.

This Project is also a useful complement to efforts to restore the San Joaquin River. Restoring water to the San Joaquin River may reduce the water supply available to agriculture in the San Joaquin Valley by up to 165,000 acre feet per year.

It is very important to me to do what I can to help make up this water deficit. The Madera Water Bank is one project that can help, and I will be looking at it and other projects closely to prioritize limited Federal appropriations to address this important need.

MID, the local agency that will build, own and manage the project has already made a major financial commitment to making the water bank a reality. MID has spent $37.5 million to purchase the nearly 14,000 acre Madera Ranch, which will be the site of the water bank, and millions more on studies. This land is ideal for storing water in the aquifer. Over 11,000 acres of the ranch also constitute valuable habitat for numerous species and contain large sections of the region's native grasslands that will be preserved.

The Energy and Natural Resources Committee held a hearing on the predecessor legislation, H.R. 3897, which passed the House of Representatives in the 109th Congress. As a result of that hearing, two changes were made to the legislation.

First, the total cost of the project is capped at $90 million. Under the legislation, the maximum Federal contribution will be $22.5 million or 25 percent of the total cost of the project, whichever is less. This change provides certainty and limits the Federal Government's financial exposure in supporting this project.

The second change to last year's legislation is the decision to declare the project ``feasible'' without further study. The reason for this approach relates to the project's unusual history.

The feasibility of constructing a water bank on the Madera Ranch property has been under consideration for over a decade. In 1996 the Bureau began studying this possibility, and in 1998 the Bureau finalized plans to fund a water bank on the property. After conducting extensive studies regarding the feasibility of building a water bank on the property, the Bureau was prepared to pay over $40 million for the property and $60-$70 million to construct the water bank. This total amount, in excess of $100 million, is significantly more than the cost of MID's water bank almost 10 years later. Although the Bureau eventually withdrew from the project because of local concerns regarding sizing, water quality, and nonlocal ownership issues, no one has ever disputed the suitability of the site for a water bank.

After the Bureau's involvement ended, Azurix, an Enron subsidiary, attempted to build a water bank but was unable to complete the project because of many of the same concerns raised during the Bureau's efforts. However, many more studies were done during this phase for the reformulated project. MID has also conducted further studies. To date, over $8 million has been spent on studies related to the Project, exclusive of the Bureau's own extensive studies of the project.

The legislation identifies 18 specific studies done over the past decade on this project, many by the Bureau itself and others by private parties and MID, all with the Bureau's full knowledge and involvement. In many cases, the same engineering consulting firms used by the Bureau were retained to conduct these further studies. There is simply nothing left to study, and we should proceed immediately to the construction phase of this project.

The Bureau has been a long-term supporter of California agriculture, and working in partnership with the State, local governments, water users and others has helped provide irrigation water for over 10 million farmland acres.

The MID water bank is consistent with the Bureau's historical mission of supporting such locally controlled and initiated water projects. Swift enactment of this legislation is necessary to bring over 10 years of study to a conclusion and make the water bank a reality for Madera County, the surrounding region, the Central Valley and the entire State of California.

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

Mr. President, I rise today to introduce legislation to authorize the Riverside-Corona feeder. This project, which is being undertaken by Western Municipal Water District, would provide one of California's fastest growing but drought prone regions, with 40,000 acre-feet of new supply at a reasonable cost of approximately $370 per acre foot. The project would efficiently integrate groundwater storage with existing surface supply management.

The purpose of the Riverside-Corona feeder water supply project is to capture and store new water in the underground aquifer in wet years in order to increase water supply, reduce water costs, and improve water quality. The project will include about 20 wells and 28 miles of pipeline. Studies have shown the safe annual yield of the aquifer is about 40,000 acre-feet.

The project would allow locally stored water to replace the need to import water from Colorado River and State water project sources in times of drought or other shortages. The project proposes to manage the ground water levels by the construction of ground water wells and pumping capacity to deliver the pumped ground water supply to water users. A new water conveyance pipeline is also proposed that will serve western Riverside County.

For water users, dependence on imported water in dry years will be reduced, water costs will be reduced, and water reliability will be improved.

There are also very important environmental remediation aspects of the project. Up to half of the wells would be placed within plumes of VOCs and perchlorate. These wells could remediate about 20,000 acre- feet of currently contaminated water per year. Detailed feasibility studies and environmental reports have been prepared and approved by Western Municipal Water District and certified by the State of California.

The California State Water Resources Control Board recognizes that the Riverside Corona feeder is an important project, recently awarding it $4.3 million from proposition 50 competitive grant funds.

Because water agencies understand that the project is integral to regional water planning, the Riverside-Corona feeder has the support of agencies upstream in San Bernardino County and downstream in Orange County. This bill is also supported by and fully consistent with the Metropolitan Water District of Southern California's Integrated Resource Plan, the Santa Ana Watershed Project Authority's Integrated Watershed Plan, and the water management plans for the cities of Riverside, Norco and Corona as well as the Elsinore Valley Municipal Water District.

This is a bipartisan initiative, as witnessed by the list of cosponsors of the House version of the bill I introduce today. I urge my colleagues to support this bill to help meet the West's water supply needs and to reduce our dependence on the Colorado River.

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

Mr. President, together with my good friend and colleague, Senator Barbara Boxer, Chairman of the Committee on the Environment and Public Works, I am pleased to introduce today legislation to help the San Francisco bay area a region with a growing population, limited

water resources, and a unique environmental setting, address its critical water needs.

The bill, the Bay Area Regional Water Recycling Program Authorization Act of 2007, would help seven bay area communities increase their municipal water supplies through innovative and much-needed water recycling projects.

These projects offer significant benefits. For California and the Federal Government such benefits include: the preservation of State and Federal reservoir supplies for higher uses rather than for urban landscape irrigation, particularly in drought years; and, a cost effective, environmentally friendly, implementable solution for increased dry year yield in the sensitive bay-delta region. Regional and local benefits include: the preservation of ever declining water supplies from the Sierra and delta for higher uses; assistance in drought-proofing the region through provision of a sustainable and reliable source of water; and reduction in wastewater discharges to the sensitive bay-delta environment.

The Bay Area Regional Water Recycling Program is a partnership between 17 local bay area water and wastewater agencies, the California Department of Water Resources and the U.S. Bureau of Reclamation that is dedicated to maximizing water recycling throughout the region. The regional approach taken by the bay area project sponsors ensures that projects with the greatest regional, statewide, and national benefits receive the highest priority for implementation.

This bill would authorize the U.S. Bureau of Reclamation to participate in seven bay area water recycling program projects that are closest to completion. Each community with a project would be eligible to receive 25 percent of the project's construction cost. The total cost of the seven projects is $110 million, but the Federal Government's share is only $27.5 million. State funding is available for these projects.

For the most part, the projects are ready to proceed and start delivering their benefits the projects having been repeatedly vetted, both internally at the local level and through the various steps of the Federal review process but Federal funding is needed to make implementation a reality and to allow the many benefits of these projects to be realized.

Specifically, the bill would authorize the Secretary of the Interior to participate in the following bay area water reuse projects: Antioch Recycled Water project--Delta Diablo Sanitation District, city of Antioch; North Coast County Water District Recycled Water project-- North Coast County Water District; Mountain View/Moffett Area Water Reuse Project--city of Palo Alto, city of Mountain View: Pittsburg Recycled Water Project-Delta Diablo Sanitation District, city of Pittsburg; Redwood City Recycled Water project--city of Redwood; South Santa Clara County Recycled Water Project-Santa Clara Valley Water District, South County Regional Wastewater Authority; and, South Bay Advanced Recycled Water Treatment Facility--Santa Clara Valley Water District, city of San Jose.

These seven projects are estimated to make 12,205 acre-feet of water available annually in the short term, and 37,600 acre-feet annually in the long term, all while reducing demand on the delta and on existing water infrastructure.

Congressman George Miller introduced a companion bill, H.R.1526, in the House on March 14, 2007. The bill was cosponsored by other bay area lawmakers, including Representatives Anna Eshoo, Ellen Tauscher, Jerry McNerney, Tom Lantos, Mike Honda; Zoe Lofgren, and Pete Stark.

Water recycling offers great potential to States like California that suffer periodic droughts and have limited fresh water supplies. To address these issues, the bill would establish a partnership between the Federal Government and local communities to implement a regional water recycling program in the bay area. I urge my colleagues to join in support of this legislation.

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

Mr. President, I rise today with Senators Barbara Boxer and Daniel Inouye to introduce legislation that would authorize the National Park Service to conduct a special resource study of the Tule Lake Segregation Center, a World War II-era Japanese American internment camp, located in Northern California.

My colleagues in the House of Representatives, Congressman John Doolittle and Congresswoman Doris Matsui, also are introducing companion legislation today.

In 1942, as part of a wave of anti-Japanese sentiment following the attack on Pearl Harbor, Franklin D. Roosevelt signed Executive Order 9066 to authorize the U.S. military to incarcerate Japanese American families from California and other west coast States, in violation of their due process rights afforded to all Americans.

Over the years, California's political leaders have led a national bipartisan effort to ensure that this chapter in American history is not forgotten.

In 1992, my colleagues in the California congressional delegation passed bi-partisan legislation to establish the Manzanar National Historic Site, the Nation's first unit of the National Park System dedicated to telling the story of the wrongful internment of the Japanese American community during World War II.

I am pleased to say that Manzanar has been a terrific success story. My colleague Representative Jerry Lewis and I were able to secure Federal appropriations to refurbish the camp auditorium to accommodate the tens of thousands of visitors to the site. Last year, nearly 90,000 people visited the Manzanar National Historic Site to learn about this unfortunate chapter in United States history.

As part of the Manzanar legislation, Congress directed the National Park Service to conduct a study of the other camp sites and to recommend National Historic Landmark designation for these sites. Based on this study, the Department of the Interior designated Tule Lake as a National Historic Landmark last year, upon finding that the remaining 42 acres of federally owned land at the site possesses national significance.

Of all of the camp sites, Tule Lake has retained some of the most significant historic features dating back to the internment. The federally owned lands include numerous camp buildings in their original locations, most notably the camp stockade, which was a ``jail within a jail.'' The finding of the site's national significance by the Secretary of the Interior last year is a key step forward in the process to evaluate the site's potential for management by the National Park Service.

Over the past several years, the Tule Lake Preservation Committee, the Japanese American Citizens League, the Japanese American National Museum and other local, regional and national partners have worked with Modoc County and the local community to develop a recommendation to study the potential for designation of the Tule Lake Segregation Center as a National Historic Site. I am pleased that this legislation has been endorsed by the Modoc County Board of Supervisors.

Although the Tule Lake Segregation Center is already a National Historic Landmark, the 42-acre site is not managed by the National Park Service. This bill would authorize the National Park Service to study the feasibility and suitability of managing the Federal lands at Tule Lake as a 42-acre National Historic Site, to be managed as part of the Lava Beds National Monument. Through this legislation, the NPS will develop various management alternatives for the site and give the public an opportunity to comment on the alternatives, through a public process. In light of the recent National Park Service work to prepare the national historic landmark designation, the cost to complete this study is quite modest. Upon completion of the study, the NPS would transmit the study to Congress for review.

This year marks the 65th anniversary of the internment of Japanese- Americans, when the Federal Government ordered Japanese American men, women and children to report to temporary assembly centers, including 13 centers in California. Many families were broken up as fathers were sent to prisons, work camps and Department of Justice camps hundreds of miles away. Without hearings or any evidence of disloyalty, Japanese- American families were transported to assembly centers in April and May of 1942. The largest assembly center was at the Santa Anita racetrack, which held over 18,000 people in horse stalls and other makeshift quarters.

Deprived of their basic constitutional rights, Japanese-American citizens and resident aliens were held in these centers until the U.S. government built more permanent camps in 10 locations in California and throughout the Western States and Arkansas. Together, these camps held over 120,000 Japanese Americans, of which about three quarters were living in California before the war.

My good friend, the late-Representative Robert Matsui, was just an infant when his family was ordered from their home in Sacramento to the Pinedale Assembly Center. From there, he was sent to the Tule Lake, Segregation Center in Modoc County, CA not far from the Oregon border.

Like the other camps, the Tule Lake Relocation Center was constructed in a remote area, on a large tract of federally owned land, managed by the U.S. Bureau of Reclamation. Prisoners there held frequent demonstrations and strikes, demanding their rights under the U.S. Constitution. As a result, Tule Lake was made a ``segregation camp,'' and internees from other camps who had refused to take the loyalty oath or had caused disturbances were sent there.

Despite these injustices, many young men in camp answered the call to serve in the U.S. Army and demonstrated their loyalty to the United States and to defend the same basic constitutional freedoms that had been violated by the U.S. Government's actions. Japanese Americans served with great valor and bravery in Europe, including our colleague Senator Daniel Inouye.

During its operation, Tule Lake was the largest of the 10 camps, with 18,789 people housed in makeshift barracks. Opened on May 27, 1942, Tule Lake was one of the last camps to be closed, staying open until March 20, 1946, 7 months following the end of World War II.

Following World War II, our Nation has recognized that the forced evacuation and incarceration of Japanese Americans was wrong and that there was no basis to question the loyalty and patriotism of Japanese Americans.

The internment of Japanese Americans during World War II was a grim chapter in America's history. Conducting this special resources study,

and the potential creation of the Tule Lake National Historic Site, will help ensure that we honor surviving internees during their lifetime and will serve as a lasting reminder of our ability to inflict pain and suffering upon our fellow Americans.

It is important that we recognize the historic significance of Tule Lake Segregation Center within the lifetimes of the few surviving Japanese-American internees, before many of their stories are lost.

I urge my colleagues to join me in supporting this legislation. I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of H.R. 3580, received from the House and is at the desk.

Mr. President, every day, families across America rely on the Food and Drug Administration in ways they barely realize. When they put dinner on the table, they are counting on FDA to see that it is free from contamination. When they care for a sick child, they are trusting FDA to make sure the drugs prescribed are safe and effective. From pacemakers to treatments for cancer to the foods we eat, FDA protects the health of millions of Americans, and oversees products that account for a quarter of the U.S. economy. The agency does all this on a budget that amounts to less than 2 cents a day for each citizen.

Yesterday, the House of Representatives approved legislation on FDA reform by a broad bipartisan majority of 405 to 7. Our House colleagues from all parts of the political spectrum united to send that bill to the Senate with a resounding bipartisan endorsement. We cannot wait another month, another week--or even another day. We must take action here and take action now to send that bill to the President.

The stakes could not be higher. Funding for the FDA's vital safety mission is reaching the breaking point. Unless we act, the FDA Commissioner will send a letter tomorrow to over 2,000 employees informing them that their jobs are slated for termination. This legislation provides nearly $500 million in new resources for FDA-- including over $50 million for drug safety and $6 million for review of direct to consumer ads.

Americans are worried about the safety of the products they use--from food to toys to drugs--and they are right to be worried. Dangerous lapses in safety oversight have exposed American families to intolerable risks from lead paint in toys, to bacteria in foods, to drugs that cause unreported and lethal side effects. The right response is comprehensive, considered and bipartisan legislation--and that is what we have before us today.

At the heart of our proposal is a new way to oversee drug safety that is flexible enough to be tailored the characteristics of particular drugs, yet strong enough to allow decisive action when problems are discovered.

A second major element of our legislation is a public registry of clinical trials and their results. A complete central clearinghouse for this information will help patients, providers and researchers learn more and make better health care decisions. Now, the public will know about each trial underway, and will be able to review its results.

Our bill recognizes that innovation is the key to medical progress by establishing a new center, the Reagan-Udall Foundation, to develop new research methods to accelerate the search for medical breakthroughs.

The bill helps preserve the integrity of scientific review by improving FDA's safeguards against conflicts of interest on its scientific advisory committees, and it will end the abuse of citizens petitions that are too often used not for their intended purpose of brining important public health concerns to the attention of the FDA, but rather to delay the approval of generic drugs.

The proposal before the Senate today strikes the right balance on this issue. It rightly states that the mere filing of a citizen petition should not be cause for delay, but allows FDA to delay the approval of a generic application if it determines that doing so is necessary to protect public health. This is the right approach. It prevents abuse, but protects health.

The legislation also includes important reforms of direct-to- consumer, or DTC, advertising. I thank Senator Roberts and Senator Harkin for working with Senator Enzi and me and with many members of the committee on this important provision.

Instead of the moratorium included in our original bill, the current proposal puts in place strong safety disclosures for DTC ads, coupled with effective enforcement. Under current law, safety disclosures can be an afterthought--a rushed disclaimer read by an announcer at the conclusion of a TV ad while distracting images help gloss over the important information provided. Our proposal requires safety announcements to be presented in a manner that is clear and conspicuous without distracting imagery. We also give FDA the authority to require safety disclosures in DTC ads if the risk profile of the drug requires them.

Our legislation also takes important first steps toward a safer food supply. These are only first steps--our committee will work on a comprehensive package of food safety legislation in the fall--but they are important steps. Consumers and FDA have too little information about contaminated food. Our bill creates a registry and a requirement to report food safety problems. Consumers will have information about recalls at their fingertips, and FDA's response will not be slowed by antiquated and inefficient reporting systems. Our bill also establishes strong, enforceable quality standards for the food we give our pets, to guard against the problems of tainted pet food that we have seen in recent months.

In this new era of the life sciences, medical advances will continue to bring immense benefits for our citizens. To fulfill the potential of that bright future, we need not only brilliant researchers to develop the drugs of tomorrow, but also strong and vigilant watchdogs for public health to guarantee that new drugs and medical devices are safe and beneficial, and that they actually reach the patients who urgently need them. Congress has ample power to restore the luster the FDA has lost in recent years, and this bipartisan consensus bill can do the job. I ask my colleagues to approve this needed legislation without delay.

H.R. 3580, the Food and Drug Administration Amendments of 2007, does a great deal to improve the regulatory process and to strengthen FDA's ability to enforce drug safety standards, particularly in the postmarket period. A recent study by the Institute of Medicine described FDA's post-market drug safety authority as ``aging and inadequate.'' Currently, FDA's ability to address potential health problems that become known after the drug has gone on the market is very limited. This is a serious weakness in the present system that must be corrected. This legislation will give FDA the authority, for the first time, to compel a drug company to add warnings of newly discovered risks on the drug label. As a result, in many cases the health risks involved in using potentially dangerous drugs will be disclosed to the public much sooner than they are today.

At the same time, this legislation makes clear that drug companies will continue to have the same independent responsibility to update the warning labels on their drugs in the future that they have under current law today. If a drug company learns of new dangers that its product potentially poses to the patients taking it, the company has a legal responsibility to immediately warn those patients of the risk of injury.

By enacting this legislation, we do not intend to alter existing state law duties imposed on a drug manufacturer to obtain and disclose information regarding drug safety hazards either before or after a drug receives FDA approval or labeling. We do not believe that the regulatory scheme embodied in this act is comprehensive enough to preempt the field or every aspect of state law. FDA's approved label has always been understood to be the minimum requirement necessary for approval. In providing the FDA with new tools and enhanced authority to determine drug safety, we do not intend to convert this minimum requirement into a maximum. The Institute of Medicine and others have found that FDA's past performance has been inadequate. While we fully expect substantial improvement as a result of the enactment of this bill, we cannot and do not expect the FDA or this new process to identify every drug specific safety concern before a drug manufacturer becomes aware or should have become aware of such concerns. Nor are the bill's requirements that companies disclose certain safety information to the government intended to substitute for the disclosure requirements that may be required under state law.

No one should be under the mistaken impression that the new authorities and resources provided under H.R. 3580 lessen in any way the obligation of a drug company to scrutinize vigilantly the safety signals for their drugs and proactively study such signals or change their labels when the evidence supports such a change. This new postmarket authority for FDA is not intended to alter the drug companies' independent obligation to promptly warn consumers of a drug's risks. Under current FDA regulations, a drug company is required to add new warnings to its labels as soon as it learns about new risks potentially posed by its drugs. The company must add the new warning even if FDA has not required a labeling change.

It is worth putting the situation in a little perspective. The legislation increases FDA's resources for post-market drug safety efforts significantly. FDA's current resources of about $25 million are increased by almost $55 million in the first year, to nearly $80 million. There will be increases in the next four years of $10 each year, so that FDA's post approval drug safety budget will be at about $120 million in 2012. This is the entire budget at the FDA to collect and analyze post-market safety information and respond with appropriate regulatory action. FDA must use these resources to police every prescription drug on the market--thousands of drugs.

By contrast, the drug industry had annual revenues in 2005 of over $200 billion. To be sure, significant portions of these revenues support research and development, profits, and marketing of drug products, but a mere 1 percent of these sales exceeds the entire budget of the FDA. It exceeds the agency's budget for postmarket drug safety by a factor of over one thousand. Many major brand drugs have annual revenues that exceed FDA's annual budget for postapproval drug safety. Consider the top 200 selling drugs in 2006: Merck's drug Fosamax Plus D came in 200th in 2006, with U.S. sales of $140 million. Sales from this one drug alone exceed the entire $120 million FDA budget for drug safety in the last year of this program. The 100th drug, Abbott's Kaletra, had 2006 sales of $350 million, nearly three times the FDA's annual drug safety budget for 2012. Thirtyeight drugs had U.S. sales exceeding $1 billion in 2006. The top selling drug, Pfizer's Lipitor had 2006 sales of nearly $6.6 billion, an amount more than 50 times FDA's annual drug safety budget in 2012 under this legislation.

Clearly, the resources of the drug industry to collect and analyze postmarket safety data vastly exceed the resources of the FDA, and no matter what we do, they will always have vastly greater resources to monitor the safety of their products than the FDA does. It is absurd to argue that the FDA, even with the enhanced resources and authorities provided by this legislation, commands the field when it comes to postmarket drug safety. The drug companies have the capacity to do a far more comprehensive job. If we are serious about quickly alerting the public to the health risks posed by drugs, the companies must be required to take the initiative in monitoring the safety of their products and immediately warning the public of newly discovered risks. Drug manufacturers cannot be allowed to ignore their responsibility and wait for the FDA to act.

To be sure, the legislation gives FDA the authority to command some of the resources of a drug company. FDA can order an epidemiological study or even a clinical trial, but this authority is not unlimited. Certain standards must be met before FDA can act to require a drug company to investigate a safety signal.

Importantly, a drug company has the ability and the responsibility to conduct these studies or clinical trials on its own initiative. Nothing in H.R. 3580 requires a company to wait and react to an order from the FDA for such a study or clinical trial, or to wait for FDA to order the company to change its label. The legislation retains the current, ongoing requirement, found in section 502(a) of the Federal Food, Drug, and Cosmetic Act, for a drug company to ensure that its label is not false and misleading. This statutory imperative is recognized in current FDA regulations. Section 901 of H.R. 3580 cites these regulations in the new section 505(o) of the Federal Food, Drug, and Cosmetic Act. These regulations obligate a company to propose a labeling change to enhance a warning or improve safety information without waiting to hear from FDA, and allow the company to implement the labeling change before the FDA has reviewed and approved the change.

In most cases, a drug company will learn about new risks from its product before the FDA does. Usually, it is the

manufacturer that possesses the information demonstrating a potential danger from the product. It is imperative that patients and health professionals learn about those new health risks as quickly as possible. For that reason, drug companies have, and must continue to have, an independent duty to warn drug users of the danger as soon as the company becomes aware of it. Otherwise, there will be long delays before consumers are alerted, and the number of injuries caused by the product will multiply.

What should motivate a drug company to investigate drug safety signals and take appropriate action to mitigate a safety risk? You can find the answer in several places: from the simple moral duty to do the right thing; from the duty to one's customers, who use one's products with the understanding, often promoted by direct-to-consumer advertising, that the company's highest interest is to bring safe and effective cures to the sick and ill of the Nation; and from a duty under State law to offer products that are free of defects, with adequate warnings about their risks. This legislation changes none of these duties, in any way, whether they arise from simple ethics, principles of contract law, or of tort law. Rather, the legislation provides FDA with additional resources and authority to be better able to step in when a company fails to live up to these responsibilities.

But some drug companies don't want to fully inform the public about these risks to patients' health, and they don't want to be held accountable when patients are injured or killed by their drugs. They would have liked this legislation to change the law to escape this responsibility. These drug companies wanted to convert FDA regulation from a safety floor into a ceiling, from a minimum safety standard designed to protect consumers into a liability shield designed to protect the drug companies. But Congress firmly rejected this approach.

If companies were allowed to conceal safety information until the FDA ordered them to disclose it, consumers would continue taking these dangerous drugs without knowing their risks for months or even years after the risks were discovered. Then, when the public finally learned of the risk, the drug company would be immune from suit for failing to warn its customers. Those who were seriously injured by the drug would have no legal recourse, even though the company had concealed the risk. The company would completely escape accountability for its failure to warn consumers. That would be totally unacceptable, and is not what we intend by this legislation.

Regulation by the Food and Drug Administration and product liability lawsuits against the manufacturers of harmful drugs work together to protect consumers. Both are needed to force drug companies to disclose health risks posed by their products as soon as those risks are discovered. Both are essential to identifying dangerous drugs and getting them off the market quickly. Effective regulation by the federal government and litigation by victims of dangerous drugs work hand-in-hand to keep patients safe and make drug companies more responsible. This legislation improves FDA oversight of postmarket drug safety, and does not undermine or preempt the efforts by injured patients to seek redress under State product liability law.

Congress has stated very clearly in the legislation that we do not intend the new authority being given to FDA to preempt common law liability for a drug company's failure to warn its customers of health risks. The legal duty of drug companies to warn consumers of the health risks of their products as soon as those risks are discovered is essential to effectively protecting the public from dangerous drugs. Legislation designed to protect consumers from dangerous drugs must not be distorted into a shield protecting drug companies from accountability.

Indeed, that was an important objective of the Food and Drug Administration Amendments Act, and I agree the citizens' petition language is an integral part of the final legislative effort.

I do agree. Let us be clear: The citizen petition provision is designed to address attempts to derail generic drug approvals. Those attempts, when successful, hurt consumers and the public health. The citizen petition provisions are not intended to alter laws not amended by the provision. I thank the Senator.

Medicare Claims Data

It is a great pleasure to work with my distinguished colleagues from the Finance Committee on this reauthorization of important programs at the FDA. I know they have a deep interest in seeing that the medicines that Americans take are safe and effective.

Senator Baucus and Senator Grassley have rightly raised a question regarding the interpretation of section 905 of this bill. Section 905 adds a new paragraph (3) to section 505(k) of the Federal Food, Drug and Cosmetic Act. This new paragraph establishes a system for FDA to query databases regarding information that may help detect adverse drug effects. It is essential to detect drug safety problems early, so that they may be corrected before people are hurt and an electronic drug safety system is one important tool for doing so.

The Medicare claims database is listed as one of several possible sources of data in section 505(k)(3)(C)(i)(III)(aa). I want to assure my friends from Montana and Iowa that our intent is that Medicare's participation will be determined by provisions of the Social Security Act, over which the Finance Committee has exclusive jurisdiction. Nothing in this section is intended to infringe on that jurisdiction or to in any way preempt the ability of the Finance committee to act to specify the participation or nonparticipation of the Medicare claims data base in the system established under section 905.

The matter before the Senate amends the Federal Food, Drug and Cosmetic Act. The section to which you have raised concerns authorizes use of Medicare data ``as available.'' I acknowledge that under current law, that is not possible.

I appreciate that conforming amendments in the Federal Food, Drug and Cosmetic Act may be necessary as you point out. I agree to work with the Senator in the future on this issue.

Mr. President, I ask unanimous consent that the bill be read a third time, passed, the motion to reconsider be laid upon the table, and that any statements relating to the bill be printed in the Record, without further intervening action or debate.

Mr. President, the New England Journal of Medicine, which is probably the most distinguished medical journal in not only this country, probably in the world, has made the comment that this legislation is the greatest progress, in terms of drug safety, in a century. This ought to be reassuring for every family as to the safety of their prescription drugs and also in terms of their food.

Mr. President, for the sake of our security, economy and environment, America needs a comprehensive energy policy that is independent of foreign energy sources and weans America off of fossil fuels.

Last year, I introduced comprehensive energy legislation that would address the many challenges across our economy to achieving sustainable energy independence. I am very hopeful that this Congress will soon take steps to bring forward a comprehensive energy bill that will address many of the areas I believe are essential to this effort. I have cosponsored many of the individual planks of this comprehensive effort, and today I want to address how we can ensure that this energy policy does not have an expiration date or fall short of its laudable goals.

Today I am introducing the Energy Independence Act.

The Energy Independence Act will deliver energy independence to Americans by providing an energy plan that has the capacity to change with innovation. My bill will ensure that our energy policy will increase the efficiency and decrease the environmental impact of America's energy policy, and encourage our energy policy to adapt to our needs and abilities.

My bill will set a congressional goal of achieving energy independence by 2017. ``Energy independence'' is defined as meeting all but 10 percent of our energy needs from domestic energy sources. The bill will also set a congressional goal of achieving independence from fossil fuels by 2037.

My bill will also create a Blue Ribbon Energy Commission, which will meet every two years starting in 2009, to evaluate our progress in efforts to become energy independent, and to recommend changes to be made in reports to Congress.

These are achievable goals.

Petroleum, mostly used for transportation, accounts for 84 percent of our imported energy. Transportation accounts for roughly 28 percent of our energy use. I support raising CAFE standards, and have cosponsored S. 357, legislation by Senator Feinstein which would raise these standards to 35 miles per gallon by 2019. Studies show that raising CAFE standards to 40 miles per gallon would save over 36 billion gallons of gas per year, and creating efficiency standards for replacement tires would save more than 7 billion barrels of oil over the next 50 years. Creating incentives for commuting by train or bus, and funding upgrades and new starts in public transit services, such as the purple line of the DC metro, will also make a difference--in an average year, the round trip to work uses over 250 gallons of gas and creates about 5,000 pounds of carbon dioxide emissions.

As part of a comprehensive energy bill we should also be mindful of the long-term effects of our energy policy on the environment, our landscape, and our health. I cosponsored S. 309, legislation by Senators Sanders and Boxer that provides for an economy-wide emissions cap and trade program. Enacting an economy-wide cap and trade program will ensure that our energy policy will be truly sustainable.

America currently gets only 6.3 percent of its energy from renewable energy sources. Current ideas for addressing this problem focus on trying to make the large up-front investment in infrastructure required to produce renewable energy less daunting, by creating a long-term market for renewable energy through increasing the Federal Government's use of renewables and creating a Federal renewable portfolio standard to make utilities offer renewable energy to American consumers, and by making incentives like the renewable production tax credit permanent. I support creating Federal renewable portfolio standard, and will cosponsor legislation to be offered by Senator Bingaman to do so. I have also cosponsored S. 590, Senator Smith's legislation that would extend solar tax incentives through 2016, while expanding these incentives to cover more of the up-front investment required to use solar energy.

In order to get to energy independence we must substantially increase our investment in energy research. I cosponsored S. 761, Senator Reid's America COMPETES Act, which will increase R&D funding for the Department of Energy, increase the DOE's emphasis on advanced energy research to overcome the long-term and high-risk technological barriers to the development of energy technologies, and implement recommendations made by the National Academies of Sciences report Rising Above a Gathering Storm.

I will be advocating other areas of energy policy reform, including increasing funding for weatherization, providing incentives for telecommuting, and providing additional energy efficiency standards for appliances.

We can do better, and the one overarching theme in the quest for a sustainable, long-term energy policy is the need to be able to be flexible and change our energy policy to suit our needs, capacity, research and development. My bill will give us the ability to provide long-term, bipartisan solutions that will address our energy policy going forward, and give us the flexibility, and the considered solutions of experts, to give the American people the energy policy they deserve.

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

Mr. President, today I rise to introduce the Voluntary Medicare Quality Reporting Act of 2007. I thank my good friend, the gentleman from Pennsylvania, Mr. Specter, for joining me in this effort. This is an important bill for tens of millions of Medicare beneficiaries, for the physicians, nurse practitioners and allied health professionals who treat them, and for the future of the Medicare program.

At the end of this year, providers will again face the prospect of an across-the-board cut in their Medicare reimbursements. The scheduled cut for 2008 is the largest ever, 9.9 percent. These cuts are the result of a flawed reimbursement system created in 1997 that uses the Sustainable Growth Rate formula, or SGR, to determine an acceptable increase in the growth of provider expenditures.

Medicare reimbursements increase when the previous year's payments do not exceed a target level that is based on the growth of our economy. However, when the previous year's payments exceed that target level, reimbursements are cut. According to MedPAC, the SGR formula would reduce Medicare provider reimbursements by 40 percent over the next eight years if Congress does not act. MedPAC is also concerned that over the next several years these reductions ``would threaten beneficiary access to physician services over time, particularly those provided by primary care physicians.'' MedPAC recognizes the importance of provider participation in the Medicare program, particularly in our rural and underserved urban areas where the decision to not accept new Medicare patients can make all the difference in seniors' access to medical care.

Congress recognizes this as well, and so we have intervened to prevent scheduled cuts resulting from SGR from taking effect. For all except the newest members of this body, this process of enacting a ``physician fix'' is a familiar scenario. For the past four years, Congress has acted to prevent these cuts to providers, usually through a last-minute provision added to a must-pass bill.

In the 109th Congress, I introduced bipartisan legislation implementing MedPAC's recommendations and calling for Congress to repeal the SGR formula and update provider reimbursements by the cost of care. Replacing SGR will require a thoughtful and protracted process involving the input of lawmakers and the provider community, and it is costly, but it is something that we must do.

The most recent ``fix'' was made to the 2006 Tax Relief and Health Care Act, Public Law 109-432. That law froze payment rates, staving off an across-the-board cut of 5.1 percent. Congress also added a quality reporting system called the Physician Quality Reporting Initiative program PQRI, which made providers eligible for a bonus payment of 1.5 percent of their total allowed Medicare charges if they report to HHS on certain quality measures starting in July 2007.

This new system is also known as ``pay-for-reporting,'' and it is based on the concept that physicians should receive an increase in Medicare reimbursement only once they have participated in extensive quality reporting. Across my State, I have heard serious concerns that this will lead to a mandatory reporting system in the near future, and that we will soon see an untested ``pay-for-performance'' system in place.

Now, I think all my colleagues would agree that our seniors deserve the highest quality care. But in our quest for improved quality, we must answer two questions here: should we proceed with an untested system of reporting requirements just for the sake of reporting, and will we actually achieve better care for our seniors via the PQRI.

I am very concerned about implementing reporting requirements that have not been tested. I believe that we must have the right process in place for defining a quality reporting system for services provided to Medicare beneficiaries by health care professionals. We should not be establishing reporting requirements for health professionals just for the sake of reporting, and we should not be moving forward with this system until we have adequate time to evaluate each stage of its development.

Current law does not provide sufficient time to assess the appropriateness and effectiveness of this new system. Nor do they take into account the fact that most physicians and other health professionals have no experience in quality reporting and do not have in place the necessary health information technology and administrative infrastructures to participate in a reporting system.

The bill I am introducing today will assure that health professionals will be at the center of the process for defining areas where quality measures are needed, as well as for defining the relevant measures themselves. Why is this important? Health professionals must be actively engaged in developing and implementing an effective reporting system because they are on the front lines of health care delivery, and they best understand the nexus between care delivery and quality measurement. The development process for quality measures must be transparent and consistent for all health professionals because they are the ones who will determine its successful implementation.

Additionally, quality measures should be tested across a variety of specialties and practice settings before they are included in a reporting system because measures must be clinically valid to be relevant for defining quality, and because physicians and health professionals practice in a variety of settings, for example: small vs. large practices, urban vs. suburban vs. rural locations, office-based vs. hospital-base practices.

Most importantly, we should not be using hastily devised quality measures to justify reimbursement cuts. There are some who advocate pay-for-performance as a way to slow the growth of physician spending. They think we can accomplish lower physician expenditures by setting arbitrary standards and then cutting payments to physicians who fail to meet them. But across America, there are practices that would face tremendous obstacles in meeting such standards: they lack of the information technology necessary to document and report standards in a timely manner; they see patients with economic and language barriers that will result in higher noncompliance rates; they treat a patient population for whom ethnic and racial differences require different clinical interventions than for other patients. Ignoring these considerations will not only fail to dramatically improve quality, it will significantly penalize providers who treat traditionally underserved populations.

This bill provides an opportunity to thoughtfully and carefully develop effective quality measures that reflect differences in practice patterns, to share our findings, and to determine and encourage the most cost-effective methods of providing the highest quality care.

Rather than moving forward precipitously in 2008 with a permanent Medicare quality reporting system after a transitional 6-month period this year, as current law requires, our bill, the Voluntary Medicare Quality Reporting Act of 2007, instead would establish a more realistic timeline for quality measure reporting by health professionals. It does so by:

Requiring the Secretary first to evaluate the 6-month transitional reporting system and reporting findings to the Congress by June 1, 2008;

Requiring the Secretary to undertake demonstrations for defining appropriate mechanisms whereby health professionals may provide data on quality measures to the Secretary through an appropriate medical registry;

Allowing physicians and other eligible professionals to continue reporting to the Secretary quality measures developed for 2007, in order for the Secretary to refine systems for reporting quality measures;

After completion of the evaluation, phasing in a permanent Voluntary Medicare Quality Reporting Program, with implementation beginning January 1, 2010, based on a consistent set of rules that define an orderly and transparent process of quality measure development;

Requiring that the Physician Consortium for Performance Improvement of the American Medical Association be the beginning point for the designation of clinical areas where quality measures are needed;

Having the Consortium, in collaboration with physician specialty organizations and other eligible professional organizations, develop and propose quality measures to a consensus organization such as the National Quality Forum for endorsement; and

Prohibiting the Secretary from using any measures that have not been recommended by the Consortium and endorsed by the consensus organization.

I am confident that with all of these measures we will achieve a successful and effective quality reporting system that will truly make a difference in the quality of care that our Medicare beneficiaries receive. At the end of this year, as Congress moves forward to address the physician reimbursement issue, I urge my colleagues to support this rational approach to promoting quality and guaranteeing access to care.

Mr. President, today the full Senate will probably agree to legislation--H.R. 3580, the Food and Drug Administration Amendments Act of 2007--that constitutes a massive overhaul and expansion of the Food and Drug Administration's authorities. Up until a couple days ago, determining the scope and details of the bill was an open and bipartisan process. Unfortunately, all of that changed at the eleventh hour and we were locked out of discussions to determine what a final product would look like. Now we are forced to either accept what we do not fully agree with or cause thousands of FDA employees to lose their jobs. This is not the way to ensure that we ``get it right'' with drug safety.

While this bill achieves the important and necessary objectives of reauthorizing the Pediatric Research Equity Act, the Best Pharmaceuticals for Children Act, the Pediatric Medical Device Safety and Improvement Act, the Prescription Drug User Fee Amendments, the Medical Device User Fee Amendments, and establishing a scientifically- based surveillance system for drug safety risks. There was still important work to be done to complete a bipartisan product. Because of unfair Democratic Majority tactics I and my colleagues have no opportunity to further amend and perfect this legislation.

Furthermore, I am frustrated that certain important provisions were removed from the final language of the bill at the last minute. We lost a provision to provide incentives for developing new antibiotics--a disastrous decision at a time when we are seeing a huge rise of antibiotic resistance in this country. Last minute negotiators also refused to recognize that patients desiring marijuana for medical purposes deserve to know critical information about whether or not marijuana can be safely used. Finally, the final bill did not contain an important Senate-passed resolution to protect American pharmaceutical companies' intellectual property rights around the globe.

This legislation is a very delicate balancing act. No drug is completely safe--otherwise a doctor's prescription wouldn't be needed-- but we do have to ensure that lifesaving medicines are able to get to patients. New authorities in the area of Risk Evaluation and Mitigation Strategies, REMS, labeling, and postmarket commitments should not be taken lightly. These new authorities we are giving the FDA need to be used based on a measured assessment of risk vs. benefit in the intended patient population. For instance, labeling changes should only be undertaken when reliable data clearly shows safety problems that are not already reflected in the drug's label. If that data happens to come from a third party unknown to the application holder they should have the opportunity to review it along with the Agency so that appropriate labeling changes can be made based on sound science.

Another new authority granted to the FDA in a REMS is possible restrictions on distribution and use. If used, this restriction has the potential to impede patient access to important therapies and therefore should not be imposed where less burdensome approaches are available. This concept of a ``less burdensome approach'' is an important one and it is essential that product manufacturers have the opportunity to present alternative proposals to the Agency that would accomplish the goal of safety without imposing unduly restrictive actions to products and ultimately to patients. This legislation establishes that the FDA will not limit or restrict distribution or use unless a drug has been shown to actually cause an adverse event. We absolutely need FDA to have all the tools necessary to ensure the safety and efficacy of drugs, but doctors need tools as well, and one of those important tools is new drugs on the market. I appreciate the significant changes that were made in this language of the bill between Senate HELP Committee markup and full Senate consideration. These improvements remain in the final bill and are critical to ensure that physicians--not the FDA--can make risk/benefit decisions with their patients.

This bill ensures that the FDA has broad and exhaustive authorities to make sure that drug companies are doing the right and scientifically-justified thing when it comes to drug safety and the labeling of their drugs. This authority is placed rightly in the hands of highly-trained scientists at the FDA. It is clear that Congress relies on the scientists at the FDA to assess safety risks and drug labeling and this should be squarely and solely the FDA's role-- that is why we have spent months and months trying to get this issue of drug safety right. The newly expanded role of the FDA does and should preempt State law when it comes to drug safety and labeling. In order to ensure scientific drug safety the last thing that we need is the regulatory nightmare of every State court being a mini-FDA.

Let me be clear, the FDA is the expert Federal agency charged by Congress with ensuring that drugs are safe and effective and that product labeling is truthful and not misleading. Appropriate preemption of State jurisdiction includes not only claims against manufacturers, but also against health care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling.

Product liability lawsuits have directly threatened the FDA's ability to regulate manufacturer dissemination of risk information for prescription drugs. I note a recent case in California, Dowhal v. SmithKline Beecham, where trial lawyers tried to assert that a drug company had failed to warn consumers that nicotine-replacement products allegedly cause birth defects--even though there wasn't scientific evidence to back that up. In this case, the FDA had previously told

SmithKline Beecham that they should not include such an unscientific warning in its label because it would clutter up the label's warnings that actually were scientifically justified. A California court asserted that more warnings were always better. Subsequently, that assertion was overruled unanimously by the California Supreme Court as the FDA again asserted that its scientific judgment should prevail. The case was not properly before the court by operation of the doctrine of primary jurisdiction. Unless State law is preempted in this area, State law actions can conflict with the FDA's interpretations and frustrate the FDA's implementation of its statutory and scientific mandate.

Should the FDA's scientific judgment on drug safety and labeling be set aside, we would risk eroding and disrupting the truthful representation of benefits and risks that medical professionals need to make decisions about drug use. As a physician, I know that exaggeration of risk can discourage the important and right use of a clinically therapeutic drug. Superfluous liability concerns can create pressure on manufacturers to expand labeling warnings to include merely speculative risks and limit physician appreciation of potentially far more significant contraindications and side effects.

I note that the FDA has previously stated that ``labeling that includes theoretical hazards that are not well grounded in scientific evidence can cause meaningful risk information to `lose its significance.' Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health.'' In this bill, we have created a clear labeling pathway between the FDA and a drug sponsor in this bill to ensure that consumers get scientifically accurate and appropriate warning of drug safety risks.

Furthermore, if not preempted in drug safety information and labeling, State law could conflict with achieving the full objectives of Federal law if it precludes a firm from including certain labeling information. If a manufacturer then complies with State law, the firm would be omitting a statement required under Sec. 201.100(c)(1) as a condition on the exemption from the requirement of adequate directions for use, and the omission would misbrand the drug under 21 U.S.C. 352(f)(1). The drug might also be misbranded on the ground that the omission is material within the meaning of 21 U.S.C. 321(n) and makes the labeling or advertising misleading under 21 U.S.C. 352(a) or (n).

While it is true that a manufacturer may, under FDA regulations, strengthen a labeling warning on its own, it is important to understand that in practice manufacturers typically consult with FDA before doing so. Otherwise they could risk enforcement action if the FDA ends up disagreeing.

Some misunderstand the FDA's labeling requirements to be a minimum safety standard and have used State law to force manufacturers to supplement safety regulation beyond that required by FDA. I want to be clear that the FDA's labeling requirements establish both a ``floor'' and a ``ceiling.'' Therefore, risk information beyond what is required by the FDA could be considered unsubstantiated or otherwise false or misleading. Given the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling additional requirements for the disclosure of risk information are not necessarily more protective of patients.

Finally, I want to specifically comment on language in H.R. 3580 that includes a new mechanism to further encourage the timely and accurate communication of new safety information on prescription drug labels. That mechanism reiterates the FDA's primacy in determining the content of prescription drug labeling, including through the new power to command a safety labeling change. New section 505(o)(4)(I) also makes clear that this enhanced safety labeling mechanism does not affect the obligation of a company to maintain a drug product's labeling in accordance with FDA's regulations, including 21 C.F.R. Sec. 314.70. This provision is meant to confirm the basic obligation of a drug's sponsor to propose--or, in some cases, make--changes to the approved labeling to reflect changes in the conditions established in the approved application and/or new information. Nothing in this rule of construction changes that obligation or FDA's ultimate authority over drug labeling; nor is it intended to change the legal landscape in this area. That is because there is an overriding Federal interest in ensuring that the FDA, as the public health body charged with making these complex and difficult scientific judgments, be the ultimate arbiter of how safety information is conveyed. In this manner, there can be confidence that uniform drug labeling conveys clear, consistent, and scientifically justified safety and medical information.

In fact, the courts have repeatedly upheld FDA's supremacy over prescription drug labeling in cases brought under State law. Nearly 20 years ago, the U.S. Court of Appeals for the Fifth Circuit emphasized that ``. . . manufacturers cannot change the language in the product insert without FDA approval,'' and accordingly ``[i]t would be patently inconsistent for a state then to hold the manufacturer liable for including that precise warning when the manufacturer would otherwise be liable for not including it.'' Hurley v. Lederle Labs. Div. of Am. Cyanamid Co., 863 F.2d 1173, 1179 (5th Cir. 1989). As a more recent Court expressed this bedrock principle, allowing a State to decide what warnings are appropriate, and thus potentially subject companies to liability for otherwise FDA-approved labeling, would upset the careful benefit-risk balance that FDA has struck in approving a product for market, and doing so would ``undermine FDA's authority to protect the public health through enforcement of the prohibition against false and misleading labeling of drug products in the Federal Food, Drug and Cosmetic Act.'' Sykes v. Glaxo-SmithKine, 484 F. Supp. 2d. 289, 312 (E.D. Pa. 2007) (internal quotation omitted) .

citizens' petitions

Mr. President, broadband communications are quickly becoming the great economic engine of our time. Broadband deployment drives opportunities for business, education, and healthcare. It provides widespread access to information that can change the way we communicate with one another and improve the quality of our lives. From our smallest rural hamlets to our largest urban centers, communities across this country should have access to the opportunities ubiquitous broadband can bring. The state of our broadband union should be broadband for all.

But the news on this front is not all good. Last month, the Organization for Economic Cooperation and Development reported that the United States has fallen to 15th in the world in broadband penetration. In some Asian and European countries, households have high-speed connections that are 20 times faster than ours, for half the cost. While some will debate what, in fact, these rankings measure, one thing that cannot be debated is the fact that we continue to fall precipitously down the list. In 2000 the United States ranked 4th; last year we dropped to 12th; and just last month we dropped to 15th. The broadband bottom line is that too many of our international counterparts are passing us by. For this we are paying a price. Some experts estimate that universal broadband adoption would add $500 billion to the U.S. economy and create more than a million new jobs.

In a digital age, the world will not wait for us. It is imperative that we get our broadband house in order and our communications policy right. But we cannot manage what we do not measure. So the first step in an improved broadband policy is ensuring that we have better data on which to build our efforts.

That is why I am here today to introduce the Broadband Data Improvement Act. This legislation will improve the quality of Federal and State data regarding the availability of broadband service. This, in turn, can be used to craft policies that will increase the availability of affordable broadband service in all parts of the Nation. This legislation will improve broadband data collection at the Federal Communications Commission and Bureau of the Census. It will direct the Comptroller General and the Small Business Administration to study our broadband challenge. It will encourage State initiatives to improve broadband adoption by establishing a State broadband data and development grant program that will authorize $40 million for each of fiscal years 2008 through 2012.

With too many of our industrial counterparts ahead of us, we sorely need the kind of granular data that will inform our policies and propel us to the front of the broadband ranks. I believe that the Broadband Data Improvement Act will give us the tools to make this happen.

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

Mr. President, the telecommunications industry started in this country as a series of wires criss-crossing the country to provide simple telegraph service. The telegraph allowed people to communicate from coast to coast in a matter of minutes, which was a marked improvement over the days required to deliver postal correspondence via the pony express. The industry quickly evolved from those initial telegraph lines with Alexander Graham Bell's invention of the telephone. This revolutionized telecommunications and created a multi- billion dollar industry.

Today, telecommunications accounts for 3 percent of this country's gross domestic income, or roughly $335 billion. It employs over 1.25 million U.S. workers. The industry is a critical driver of U.S. economic growth and innovation. Historically, advances in telecommunications resulted from AT&T's steady funding of Bell Laboratories, the world-famous research facility that discovered the transistor, the laser, radar and sonar, digital signal processors, cellular telephone technology, and data-networking technology. Indeed, research in this last field, data-networking, is the basis of the 21st century's greatest resource, the Internet.

However, today, the pace of innovation in the United States is no longer as swift or as certain. For example, much of the world's wireless technologies come from Europe, and many of the handsets are designed and manufactured in other countries like China and South Korea. Part of the problem is the decline of Bell Labs, but financial pressures from Wall Street to perform in the short-term are also partly to blame. Companies can no longer afford to invest in basic, fundamental telecommunications research with project horizons beyond 5 years. Unless we can reverse this trend, I fear that the United States may fall permanently behind in the telecommunications innovation race.

That is why I am here today, to introduce the advanced Information and Communications Technology Research Act. By rededicating our efforts to the pursuit of innovation through basic, fundamental research, we can begin to restore our Nation's historic leadership in this critical industry. Toward that end, the legislation that I am introducing today will establish a telecommunications program within the National Science Foundation to focus research on the development of affordable advanced communications services in America. It would authorize $40 million in fiscal year 2008, increasing in $5 million increments to reach $60 million in FY 2012. The bill would also establish a Federal Advanced Information and Communications Technology Board within NSF to advise the program on appropriate research topics. Finally, the bill would accelerate efforts initiated almost 4 years ago to promote spectrum sharing technologies. It would require NTIA and the FCC to initiate a pilot program within 1 year that would make a small portion of spectrum available for shared use between Federal and nonFederal government users.

I look forward to working with my colleagues on this legislation in the weeks ahead.

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

Mr. President, foreign registered ships now carry 97 percent of the imports and exports moving in the U.S. international trade. These foreign vessels are held to lower standards than U.S. registered ships, and are, virtually, untaxed. Therefore, their costs of operation are lower than U.S. ship operating costs, which explains their 97 percent market share.

Three years ago, in order to help level the playing field for U.S. flag ships that compete in international trade, Congress enacted, under the American Jobs Creation Act of 2004, Public Law 108-357, Subchapter R, a ``tonnage tax'' that is based on the tonnage of a vessel, rather than taxing the U.S. flag ship's international income at a 35 percent corporate income tax rate. However, during the House and the Senate conference, language was included, which states that a U.S. vessel cannot use the tonnage tax on international income if that vessel also operates in U.S. domestic commerce for more than 30 days per year.

This 30-day limitation dramatically limits the availability of the tonnage tax for those U.S. ships that operate in both domestic and international trade and, accordingly, severely hinders their competitiveness in foreign commerce. It is important to recognize that ships operating in U.S. domestic trade already have significant cost disadvantages vis-a-vis U.S. ships operating in international trade. Specifically, U.S-flag ships that operate solely in international trade: 1. are built in foreign shipyards at one-third U.S. shipyard prices; 2. receive $2.6 million per ship per year in Federal maritime security payments in return for making these vessels available to the Department of Defense in time of national emergency; and 3. are owned by U.S. subsidiaries of foreign corporations. By contrast, U.S. flag ships that operate both in international trade a domestic trade are: 1. built in higher priced U.S. shipyards; 2. do not receive maritime security payments, even when operated in international trade, but have the same commitments to the Department of Defense; and 3. are owned by U.S.-based American corporations. Furthermore, the inability of these domestic operators to use the tonnage tax for their international service is an unnecessary burden on their competitive position in foreign commerce.

When windows of opportunity present themselves in international trade, American tax policy and maritime policy should facilitate the participation of these American-built ships. Instead, the 30-day limit makes them ineligible to use the tonnage tax, and further handicaps American vessels when competing for international cargo. Denying the tonnage tax to coastwise qualified ships further stymies the operation of American built ships in international commerce, and further exacerbates America's 97 percent reliance on foreign ships to carry its international cargo.

These concerns were of such sufficient importance that in December 2006, the Congress repealed the 30-day limit on domestic trading but only for approximately 50 ships operating in the Great Lakes. These ships primarily operate in domestic trade on the Great Lakes, but also carry cargo between the United States and Canada in international trade Section 415 of P.L. 109-432, the Tax Relief and Health Care Act of 2006.

The identifiable universe of remaining ships other than the Great Lakes ships that operate in domestic trade, but that may also operate temporarily in international trade, totals 13 U.S. flag vessels. These 13 ships normally

operate in domestic trades that involve Washington, Oregon, California, Hawaii, Alaska, Florida, Mississippi, and Louisiana. In the interest of providing equity to the U.S. corporations that own and operate these 13 vessels, my bill would repeal the tonnage tax 30-day limit on domestic operations and enable these vessels to utilize the tonnage tax on their international income so they receive the same treatment as other U.S. flag international operators. I stress that, under my bill, these ships will continue to pay the normal 35 percent U.S. corporate tax rate on their domestic income.

Repeal of the tonnage tax's 30-day limit on domestic operations is a necessary step toward providing tax equity between U.S. flag and foreign flag vessels. I strongly urge the tax writing committees of the Congress to give this legislation their expedited consideration and approval. I ask unanimous consent that the text of the bill be printed in the Record.