Better Pharmaceuticals and Devices for Children Act of 2012

Mr. President, I rise to introduce the Small Business Taxpayer Bill of Rights Act of 2012, SBTBOR. I am very pleased that Senators Snowe, Hutchison, and Heller are cosponsors of this taxpayer- friendly legislation.

As Americans across the country race to meet today's deadline to complete their federal tax return, it is important to note that their tax burden is more than just the amount of tax paid to the federal government. Taxpayers also bear the burden of the cost of complying with the tax code. Analysts predict that taxpayers will spend over $350 billion this year alone to comply with the tax code. In addition, according to a survey by the National Small Business Association, over half of the respondents reported that they spend more than 40 hours a year dealing with federal taxes and spend more than $5,000 each year just on the administration of federal taxes. In addition, a dispute over a complex tax code with the IRS can become an expensive endeavor for small businesses, who have limited resources to fight off frivolous IRS claims. With the passage of the 2010 health care act, this burden is expected to increase in the future. At a time when job creation remains weak, small businesses should be spending their time and resources creating jobs, not cutting through miles of burdensome IRS red tape. The Small Business Taxpayer Bill of Rights seeks to mitigate this problem. It would ensure that small businesses spend less time dealing with the IRS and more time creating jobs.

The Small Business Taxpayer Bill of Rights, among other things, provides more protections and safeguards for small businesses during administrative procedures with the IRS. It would: lower the compliance burden on small business taxpayers; strengthen safeguards against IRS overreach; increase taxpayer compensation for IRS abuses and; improve taxpayer access to the court system. Amid the weakest economic recovery since World War II, American job creators urgently need such relief.

The Small Business Taxpayer Bill of Rights Act will reduce the compliance and administrative burdens faced by small business taxpayers when it comes to dealing with the IRS. The bill provides an alternative dispute resolution procedure through which a small business taxpayer may be able to request arbitration with an independent, neutral third party not employed by the IRS. In addition, the bill will make more small businesses eligible to recoup attorney's fees when a court finds that the IRS's action taken against a taxpayer is not substantially justified.

The legislation also reinforces the independent nature of the IRS Appeals Office by prohibiting it from discussing the merits of a taxpayer's case with any other department at the IRS, unless the taxpayer is afforded an opportunity to participate. Second, the bill will prevent an Appeals Officer from raising a new issue that was not initially raised by the IRS in the examination process. The SBTBOR would help to ensure the Appeals Office remains a neutral entity that effectively facilitates the taxpayer's appeals process.

The Small Business Taxpayer Bill of Rights Act will make the IRS more accountable to taxpayers by increasing the amount of damages taxpayers may receive for any collection action the IRS takes against them that is reckless, or by reason of negligence disregards the law or its regulations. Second, it increases the amount of damages taxpayers may be awarded when the IRS improperly discloses their tax returns and tax information. Third, the bill raises the monetary penalty on IRS employees who commit certain unlawful acts or disclose taxpayer information.

Finally, the legislation will improve taxpayer access to the Tax Court by expanding the role of the current ``small tax case'' procedure--an informal and efficient method for resolving disputes before the Tax Court--to include a wider variety of cases. The bill will permit taxpayers to obtain judicial review from the Tax Court when the IRS fails to act on their claim for interest abatement due to an error or delay by the IRS. Taxpayers whose property has been wrongly seized to satisfy a tax debt will have more time to claim relief and bring a civil suit against the IRS. It also makes procedural improvements for taxpayers who request innocent spouse relief. By requesting innocent spouse relief, taxpayers can be relieved of the responsibility for paying tax, interest, and penalties if their spouse improperly reported items or omitted items on their tax return.

Last week, I held an event in Houston, Texas, where I announced my intention to introduce the Small Business Taxpayer Bill of Rights Act. The event was held at the headquarters of Forge USA, which is a family- owned, medium-sized open-die forging business. Forging is a process involving the shaping of heated metal parts in which the metal is never completely confined or restrained in the dies. Forge USA has 215 employees and provides high-quality custom forged products for a variety of industries, with about 70 percent of its product going to the oil and gas industry. This is what the owners of Forge USA said about the legislation: ``Senator Cornyn's efforts to improve the rights of small businesses will mean that business owners will be able to spend more time growing their businesses and hiring more workers and hopefully less time talking to the tax man.'' I am grateful for the support of a small business like Forge USA. This legislation is also supported by the Texas Association of Business, U.S. Hispanic Chamber of Commerce, and the National Taxpayers Union, among others.

Small business owners face an especially crushing burden of paperwork, but they lack the key financial and legal resources that multinational corporations do when dealing with the tax code and the IRS. This legislation will provide relief for small businesses and will allow small businesses to spend more time expanding their business and creating jobs and less time dealing with the IRS.

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

I am pleased to be joined today by Senators Alexander, Murray, and Roberts in introducing the Better Pharmaceuticals and Devices for Children Act, BPDCA. This legislation will ensure that children are prioritized in the drug development process, as well as continue the increase in the number and quality of medical devices developed for use in children. I am particularly pleased that this bill has the support of the American Academy of Pediatrics and the Pharmaceutical Research and Manufacturers of America.

Indeed, drugs and devices work differently in children than in adults, and consequently, must be studied specifically for use in children. However, due to the fact that pediatric trials can be costly, take several years, and offer less of a return on investment, drug companies weren't initiating these trials. As a result, nearly 80 percent of drugs were used off-label in children.

This alarming statistic garnered the attention of pediatricians, medical experts, families, and ultimately, Congress. In 1997, Congress provided pharmaceutical companies with an incentive to invest in pediatric research through the Best Pharmaceuticals for Children Act, BPCA. In 2003, Congress passed the Pediatric Research Equity Act to begin requiring pharmaceutical companies to engage in these studies. Since the enactment of these laws, 426 drug labels have been revised with important pediatric information and there has been a decline in the number of drugs used off-label in children from 80 to 50 percent.

However, these laws will expire on October 1 unless Congress passes legislation to renew them. The Better Pharmaceuticals and Devices for Children Act would ensure that these laws are never at risk of expiring again. Laws that examine the safety and effectiveness of drugs and devices in adults are permanent. Children should have the same assurances. By making these laws permanent, pharmaceutical companies will also gain the certainty they need to continue wisely investing in these studies.

In making these laws permanent, we must not miss an opportunity to improve their benefits for children to ensure that more robust and timely information about the use of drugs and devices can guide clinical care. This legislation does just that.

First, it would ensure pediatric studies are planned earlier in the drug development process. Currently, pediatric study plans can be submitted to the FDA when a company submits its new drug application. This can be a very stressful time for a company and, as such, pediatric study plans are often left to the last minute. This has traditionally resulted in insufficient and inappropriate study plans, as well as delays of important pediatric data. Our legislation would require companies to submit a more robust pediatric study plan at the end of phase two in the drug development process. By this time in the process, a company already has performed the requisite clinical trial or trials in adults and has a better understanding of a drug's safety and efficacy, as well as dosing requirements. Moreover, experts at the FDA initially tried to require companies to submit a pediatric study plan at this time in the drug development process in a regulation that was struck down by the courts. However, the rationale and justification behind the regulation helped inform the drafting of this legislation and led us to believe that companies should submit their initial pediatric study plan to the FDA at the end of phase two.

The legislation would also ensure that pediatric studies are actually completed. An alarming 78 percent of pediatric studies that were scheduled to be completed by September 2007 are currently late or were submitted late. While it is appropriate for some studies to take longer than expected and we wouldn't want a pediatric study to hold up the approval of a drug for use in adults it is unacceptable for companies to fail to complete pediatric studies altogether. Our bill would give the FDA the authority to distinguish between reasonable and unreasonable delays in pediatric studies and provide the agency with critical enforcement tools to ensure required pediatric studies are completed. This legislation would also provide the FDA with the ability to better track the progress of studies and assist with any complications.

The Better Pharmaceuticals and Devices for Children Act also responds to the need for the development of pediatric medical devices in children, which can lag five to ten years behind those manufactured for adults. The pediatric profit allowance for Humanitarian Use Devices has proven to be an effective incentive for the development of new medical devices that are designed specifically for the needs of children. Our bill would continue this important policy. It would also reauthorize the Pediatric Device Consortia, which in just two and a half years, has assisted in advancing the development of 135 proposed pediatric medical devices and helped get life-saving and life-improving pediatric devices to the patients that need them.

This legislation is critical for children's health. It will help give parents peace of mind that when their doctor prescribes a medication or recommends a medical device for their kids, it is proven safe and effective for specific use in children.

It is my understanding that Chairman Harkin will be including this legislation as part of a broader initiative that the Health, Education, Labor, and Pensions Committee will soon be considering focused on improving drugs and devices. I look forward to working with Senators Alexander, Murray, and Roberts, as well as the Chairman and others on moving this bill forward before the October deadline.

I am pleased to be joined today by Senators Alexander, Murray, and Roberts in introducing the Better Pharmaceuticals and Devices for Children Act, BPDCA. This legislation will ensure that children are prioritized in the drug development process, as well as continue the increase in the number and quality of medical devices developed for use in children. I am particularly pleased that this bill has the support of the American Academy of Pediatrics and the Pharmaceutical Research and Manufacturers of America.

Indeed, drugs and devices work differently in children than in adults, and consequently, must be studied specifically for use in children. However, due to the fact that pediatric trials can be costly, take several years, and offer less of a return on investment, drug companies weren't initiating these trials. As a result, nearly 80 percent of drugs were used off-label in children.

This alarming statistic garnered the attention of pediatricians, medical experts, families, and ultimately, Congress. In 1997, Congress provided pharmaceutical companies with an incentive to invest in pediatric research through the Best Pharmaceuticals for Children Act, BPCA. In 2003, Congress passed the Pediatric Research Equity Act to begin requiring pharmaceutical companies to engage in these studies. Since the enactment of these laws, 426 drug labels have been revised with important pediatric information and there has been a decline in the number of drugs used off-label in children from 80 to 50 percent.

However, these laws will expire on October 1 unless Congress passes legislation to renew them. The Better Pharmaceuticals and Devices for Children Act would ensure that these laws are never at risk of expiring again. Laws that examine the safety and effectiveness of drugs and devices in adults are permanent. Children should have the same assurances. By making these laws permanent, pharmaceutical companies will also gain the certainty they need to continue wisely investing in these studies.

In making these laws permanent, we must not miss an opportunity to improve their benefits for children to ensure that more robust and timely information about the use of drugs and devices can guide clinical care. This legislation does just that.

First, it would ensure pediatric studies are planned earlier in the drug development process. Currently, pediatric study plans can be submitted to the FDA when a company submits its new drug application. This can be a very stressful time for a company and, as such, pediatric study plans are often left to the last minute. This has traditionally resulted in insufficient and inappropriate study plans, as well as delays of important pediatric data. Our legislation would require companies to submit a more robust pediatric study plan at the end of phase two in the drug development process. By this time in the process, a company already has performed the requisite clinical trial or trials in adults and has a better understanding of a drug's safety and efficacy, as well as dosing requirements. Moreover, experts at the FDA initially tried to require companies to submit a pediatric study plan at this time in the drug development process in a regulation that was struck down by the courts. However, the rationale and justification behind the regulation helped inform the drafting of this legislation and led us to believe that companies should submit their initial pediatric study plan to the FDA at the end of phase two.

The legislation would also ensure that pediatric studies are actually completed. An alarming 78 percent of pediatric studies that were scheduled to be completed by September 2007 are currently late or were submitted late. While it is appropriate for some studies to take longer than expected and we wouldn't want a pediatric study to hold up the approval of a drug for use in adults it is unacceptable for companies to fail to complete pediatric studies altogether. Our bill would give the FDA the authority to distinguish between reasonable and unreasonable delays in pediatric studies and provide the agency with critical enforcement tools to ensure required pediatric studies are completed. This legislation would also provide the FDA with the ability to better track the progress of studies and assist with any complications.

The Better Pharmaceuticals and Devices for Children Act also responds to the need for the development of pediatric medical devices in children, which can lag five to ten years behind those manufactured for adults. The pediatric profit allowance for Humanitarian Use Devices has proven to be an effective incentive for the development of new medical devices that are designed specifically for the needs of children. Our bill would continue this important policy. It would also reauthorize the Pediatric Device Consortia, which in just two and a half years, has assisted in advancing the development of 135 proposed pediatric medical devices and helped get life-saving and life-improving pediatric devices to the patients that need them.

This legislation is critical for children's health. It will help give parents peace of mind that when their doctor prescribes a medication or recommends a medical device for their kids, it is proven safe and effective for specific use in children.

It is my understanding that Chairman Harkin will be including this legislation as part of a broader initiative that the Health, Education, Labor, and Pensions Committee will soon be considering focused on improving drugs and devices. I look forward to working with Senators Alexander, Murray, and Roberts, as well as the Chairman and others on moving this bill forward before the October deadline.

Mr. President, I rise today to introduce the Lower Farmington River and Salmon Brook Wild and Scenic River Act. I first would like to thank my colleague, Senator Blumenthal, for joining me as a cosponsor of this legislation, and also wish to thank Congressman Chris Murphy, who recently introduced an identical bill in the House.

My work to preserve and protect the Farmington River dates back many years, and holds a special place in my heart. In 1993 and 1994, in my first term in office, I worked with Congresswoman Nancy Johnson to introduce and pass legislation that added 14 miles of the Upper Farmington River, or the west branch of the river, to the National Wild and Scenic River System, becoming Connecticut's first addition to the system. In 2006, I again had the privilege of working with Rep. Johnson and Sen. Chris Dodd to introduce and pass the Lower Farmington River and Salmon Brook Wild and Scenic River Study Act, which authorized a study of the Lower Farmington, or the east branch of the river. Now complete, the study found that the Lower Farmington River and Salmon Brook possess outstanding natural, cultural, and recreational values. I am honored to return to the Senate floor today to introduce this legislation, which would add the Lower Farmington River and Salmon Brook to the Wild and Scenic Rivers System in order to preserve the extraordinary ecological and recreational values it brings to our state.

Passing through ten towns in northwestern Connecticut, the Lower Farmington River and Salmon Brook is home to extensive wetlands, unique geology, and stunning vistas. The pristine and unique qualities of this river system and the surrounding landscape provide visitors and residents alike, a special location for hiking, paddling, and fishing. This unspoiled natural retreat has a rich history that is only rivaled by its vibrant biodiversity. Archeologists have revealed that sites surrounding the river date back over 11,000 years. The timeline that has been discovered chronicles important Native American development as well as the birth and growth of our nation. From

the prehistoric campsites, to the Underground Railroad network, and burgeoning manufacturing that sent goods to markets across the world, the river and its banks are an essential component of our nation's history.

But the importance of the Lower Farmington River and Salmon Brook goes beyond its contribution to our nation's history. Among the country's most biologically diverse ecosystem, the river is home to 30 species of finfish, 105 bird species, and the only river in New England that is home to all 12 of the freshwater mussel species native to the region, one of which is a federally listed endangered species. Since prehistory the rich biodiversity has also benefited agriculture along the banks of this river system. Driven by the unique qualities of the soil, Native Americans, colonists and Connecticut residents have harvested tobacco that is known the world over.

Today, outdoor recreationists visit the Lower Farmington River and Salmon Brook in increasing numbers. As Americans return to nature, it is essential that policies are in place which enhances stewardship and conservation in Connecticut and across the nation. Unchecked development threatens to erode biodiversity, destroy unprotected historic sites, and consume priceless natural resources. In order to combat such destruction we must have the foresight to ensure that treasures such as the Lower Farmington River and Salmon Brook remain unspoiled for today's recreational users as well as tomorrow's.

I thank Congressman Murphy, all the members of the Study Committee, and especially the Farmington River Watershed Association and its Executive Director, Eileen Fielding, for working with me to advance the Lower Farmington River and Salmon Brook's status within the National Wild & Scenic Rivers System. I reaffirm my strong support today for the river's protection, and I look forward to working cooperatively with my colleagues in making it happen.