Public Transportation Preservation Act of 2010

Mr. President, today I am joining with the distinguished senior Senator from Utah, Senator Hatch, to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. Forty percent of Americans regularly take supplements--and I am one of them. We are taking charge of our own health. We are developing healthier habits. We are waking up to the fact that we don't live to eat, we eat to live--and we need to be mindful of what we put into our bodies.

Countless people have told me how they have been helped by dietary supplements. Consumers want alternatives. They want less invasive, less expensive options. They don't want to just cure disease, they want to prevent disease. They want to feel good--and to look good.

As you know, I have long championed the cause of health prevention, and I strongly believe that safe, properly labeled dietary supplements can be an important part of a healthy lifestyle. In 1994, I introduced the Dietary Supplement Health and Education Act--DSHEA--along with my good friend Senator Hatch, and we revolutionized the way that supplements are regulated and sold in the United States.

DSHEA struck an important balance. On the one hand, it recognized the importance of enhancing consumer access to vitamins, minerals, and other dietary supplements, and it recognized the virtues of scientific research and education on the benefits and risk of supplements. On the other hand, it recognized the need for important regulatory safeguards to protect consumer health, including new safety standards, penalties for mislabeling or adulterating dietary supplements, and rules to ensure the scientific substantiation of claims regarding dietary supplements. As a result, over the last 15 years, Americans have enjoyed unprecedented access to a range of safe products that help improve their health.

In 2006, Congress identified a need for additional regulatory safeguards, and we passed a law that requires manufacturers, packers, and distributors of dietary supplements to report to FDA serious adverse events associated with the use of supplements. Dietary supplement manufacturers are also now required to register their businesses with FDA under the BioTerrorism law we passed in 2002. S. 510, the food safety legislation approved by the Senate HELP Committee last year, which I hope will soon be considered on the Senate floor, contains additional provisions that apply to dietary supplements. The legislation gives FDA the authority to revoke the registration of a dietary supplement facility in certain instances, and it authorizes FDA to initiate a mandatory recall of any food, including a dietary supplement, that will cause serious adverse health consequences or death.

In short, Congress has been active in passing laws that promote access to dietary supplements, but also ensure those products are safe for their intended uses. I am proud of our record on this issue, and I believe we have established a regulatory framework that is in the best interest of the American people and their long term health.

I am concerned, however, that not enough is being done to fully implement and enforce these dietary supplement laws. I am very pleased that FDA recently issued final regulations on current Good Manufacturing Practice for dietary supplements, but it took them nearly 15 years to get those rules on the books. In the fall of 2004, FDA opened a docket and held a public meeting on new dietary ingredients, but it has still not produced guidance on that issue. Perhaps most alarming, there are still scores of illegal products being sold in this country that masquerade as dietary supplements. Some bad actors simply slap a dietary supplement label on illegal products in the hopes that the supplement label will help those products evade notice by FDA or the label will help promote sales. These products are clearly not dietary supplements and both consumers and the legitimate dietary supplement industry have a right to be upset about their sale. I am encouraged that President Obama's FDA has been sending Warning Letters on some of these illegal products, but more needs to be done. Part of the problem is that FDA's dietary supplement program has been under- resourced. But part of the problem is that enforcement of DSHEA has not been made a priority.

That is why I am proud to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. This is an updated version of a bill that Senator Hatch and I introduced in

the 108th Congress. I am grateful that the Senator from Utah joins me again today in introducing this important legislation. Its basic goal is to give FDA the resources it needs to fully implement and enforce our dietary supplement laws, but also to hold FDA accountable for what it does with those resources.

According to FDA, full implementation of the laws governing the regulation of dietary supplement will require substantial additional resources. My bill authorizes FDA to receive the necessary sums to implement and enforce the law. It also authorizes the Office of Dietary Supplements at NIH to receive additional sums to expand research and development of consumer information on dietary supplements.

On the implementation front, the bill requires FDA to issue guidance that clarifies for consumers and industry FDA's expectations with regard to its new dietary ingredient premarket notification program.

On the enforcement front, the bill directs FDA to inspect facilities to ensure compliance with the new dietary supplement good manufacturing practice regulations; to use the authority under DSHEA to protect the public from unsafe dietary supplements; and to ensure that claims made for dietary supplements are truthful, non-misleading and substantiated. It also requires FDA to notify the Drug Enforcement Administration if FDA objects to a new dietary ingredient notification because the product may contain an anabolic steroid or an analogue of an anabolic steroid.

On the accountability front, the bill requires the Secretary of the Health and Human Services to submit an annual report to Congress that lists, among other things, how many people at FDA worked on supplement- related issues in the prior years; the number of times FDA inspected dietary supplement facilities; the number of times FDA issued a warning letter or initiated an enforcement action because a manufacturer was not in compliance; the number of times FDA objected to the marketing of a new dietary ingredient; and the number of dietary supplement claims the FDA determined to be false, misleading, or not substantiated.

The bottom line is that dietary supplements offer tremendous health benefits to Americans, but it is not fair to consumers, the FDA, or the people who make supplements if we don't take action to clarify our current regulatory requirements, to better inform everyone about the benefits and risk of these products, and to clear the market of the clearly illegal or spiked products that masquerade as supplements. The bill that Senator Hatch and I have developed is an important and measured response to these challenges. I am heartened that a number of organizations that are deeply concerned about these issues have endorsed our bill, including, among others, the United Natural Products Alliance, the Natural Products Association, the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, the Major League Baseball Players Association, and the NFL Players Association. The bill recognizes the need to implement and enforce current law in this area rather than simply discard the important balance we struck in 1994. And it is grounded in the firm belief that safe, properly labeled dietary supplements remain a vital part of our collective effort to help all Americans improve their health.

Mr. President, I rise today to discuss the Comprehensive Problem Gambling Act, a bill I introduced just moments ago with Senator Mike Johanns. This bill would establish and implement programs targeted at preventing, treating, and researching problem gambling.

Currently, the Federal Government provides millions of dollars to treat alcohol and drug addiction, but does not dedicate resources to treat the effects of problem gambling, which can destroy a person's career and financial standing, disrupt marriages and personal relationships, and encourage participation in criminal activity.

Over the past decade, gaming and gambling has grown significantly in the United States. According to the National Council on Problem Gambling, approximately 6 to 9 million American adults are problem gamblers.

The recent economic downturn only compounds this situation as many States consider relaxing gaming laws in an effort to raise state revenues. At the same time, the Federal Government and most states have devoted very little, if any, resources to the prevention and treatment of compulsive gambling. In fact, no Federal agency is currently responsible for coordinating efforts for treatment and prevention. Prevention and treatment programs have been proven to save money by decreasing the severity and prevalence of problem gambling, but cash- strapped states are struggling just to maintain funding for pre- existing programs.

I believe that if State governments benefit from gambling and lottery proceeds, then those governments have an obligation to provide assistance to those suffering from a gambling addiction. I am proud that the State of Oregon understands this concept and has one of the most comprehensive treatment systems in the country.

Through Oregon's Gambling Treatment Fund, one percent of Oregon Lottery revenues are transferred to the Oregon Department of Human Services for the administration of problem gambling services. However, decreasing lottery revenues has resulted in reduced treatment dollars.

I'd like to share the story of one of my constituents. For Toni, gambling started out as a fun trip to Reno or Las Vegas. She began playing video poker on occasion, and when she ran out of money, she would simply go home. But then the casinos brought in ATM machines, and she no longer had to leave the facility to access money. She could stay for hours, and did. Gambling quickly went from being a fun activity to an escape from problems and stresses in her life.

Before long, gambling had consumed Toni's life. She gambled away her life savings and went through credit card after credit card, racking up the cash advance limits and borrowing money from family members to pay it off. She tried to quit numerous times, but, as she describes it, the urge to gamble was much stronger than she was. Eventually, she couldn't do it anymore. She couldn't stop thinking about how she was going to get her next ``fix''. She ``felt about as low as you can go.'' She knew she had to get help.

Toni sought treatment in May 2009, and will soon reach the one year goal she set with her counselor to be gambling-free. However, she continues to face the long-term impacts of her gambling. Toni and her family live paycheck to paycheck and she worries that the debt she has accrued could cause her family to lose their house if the bank decides to raise interest on their mortgage. But Toni sees hope in her future because she had access to treatment and critical support services. While Toni has been able to start her own recovery, thousands of individuals across the country continue to struggle with their gambling addictions because there are so few prevention and treatment resources in place.

Unfortunately, the lack of education and research surrounding this issue has made it difficult to allot the appropriate resources to address these problems. The Comprehensive Problem Gambling Act would provide $14.2 million in competitive grants annually for 5 years to non-profits, universities, state agencies, and tribal governments

for prevention, research, and treatment of problem gambling.

Recent studies show conclusively that every $1 spent on treatment saves more than $2 in social costs. This legislation is a minimal investment with life-changing returns.

I urge my colleagues to join me in supporting Toni and the countless other individuals who struggle without supports by cosponsoring the Comprehensive Problem Gambling Act of 2010.

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

Mr. President, I rise today to propose legislation to address the problem of medical debt and credit scores. While historic health reform legislation enacted this year sets us on a path towards ending the crushing problem of Americans who lack health insurance, the challenges of our health care billing system remain a work in progress. One of those problems arises when our system of third-party payment leads to errors in billing and payments that, through no fault of the borrower, nevertheless undermine a borrower's credit scores. The borrower then must pay more for a home, a car, or his or her credit card, and in some cases, cannot at all get the loan he or she needs and deserves. To address this unfair burden, I have introduced the Medical Debt Relief Act.

Unlike consumer debt, Americans do not get to choose when accidents or medical emergencies happen. Medical debt is not the result of irresponsible consumer spending and is a not an indicator of poor credit. According to the Commonwealth Fund, accrued medical debt plagued nearly 72 million adults in 2007, and over 28 million American consumers were harassed by collection agencies for unpaid medical bills that same year. Research done by the Federal Reserve has found that medical bills make up the majority of non-credit card related accounts in collection and found on credit reports.

Nor is the problem of medical debt in relation to credit scores simply a question of whether one has insurance or not. Rather, medical debt credit challenges are a direct function of the nature of our insurance system. Because of the third-party payment system of insurance, medical debt is far more likely to be in dispute, inconsistently reported, mired in the complex medical payment bureaucracy, or transferred to collections without the consumer's knowledge. It can often take months, if not years, to adjudicate these claims. Unfortunately, even one negative medical collection mark can damage a consumer's credit score, thereby costing the consumer higher interest rates on automobile loans, home loans, and credit cards. It can even block the consumer from making purchases entirely. Sadly, even after the consumer has

paid off or settled delinquent medical debt, the negative mark on the credit report continues to plague the consumer for years.

The Medical Debt Relief Act is a straight forward solution to this problem. It would require the removal from a consumer's credit report those medical-related debts that have been fully paid. Companion legislation has already been introduced in the House by Rep. Mary Jo Kilroy and presently enjoys the support of 70 cosponsors. This legislation is also supported by the Consumer's Union, National Consumer Law Center and the National Association of Consumer Advocates.

I am honored today to be joined by Senators Dorgan, Schumer, Menendez, and Harkin in this effort to fix this important problem in how Americans access credit. This is common sense legislation that will offer tangible relief to the ordinary Americans who work hard, pay their bills, and want to borrow money at reasonable rates to finance the next step in their American dream. I urge my colleagues to join us in the effort.

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

Mr. President, today I am introducing the Fair Pricing for Prescription Drugs Act to help make prescription drugs more affordable for all Americans. This legislation endorses the excellent work that my colleague Senator Dorgan of North Dakota has done to promote importing prescription drugs from other industrialized countries. And it includes companion language to Congressman Welch's bill to call on the Secretary of Health and Human Services to negotiate drug prices on behalf of Medicare Part D beneficiaries. Here in the Senate, several of my colleagues, most recently Senator Bill Nelson of Florida, have tirelessly pushed the need for negotiation of drug prices. I am proud to have stood with my colleagues on these issues over the last decade--and feel strongly that Congress must move quickly to ensure that all Americans--whether they purchase private health insurance or are enrolled in Medicare--have fairly priced prescription drugs.

Allowing for importation of prescription drugs and price negotiation for Medicare Part D are common sense policies, These are changes that Congress can make to drastically improve the affordability of prescription drugs for our constituents, save the government money, and further enhance the health reform law passed earlier this year. I was pleased to be a part of that historic effort, but the health reform law was not perfect and did not go as far as it could have to reduce prescription drug prices for consumers. I have heard from thousands of Wisconsinites about the need for health reform during my time in the Senate. The health reform law empowers consumers and small businesses for the first time in our history to demand more for their health care dollar. These changes will

improve the affordability of health insurance and medical care for individuals and families. But I also continue to hear from Wisconsinites about the burden of rising prescription drug costs. They need our help.

One of the fastest ways to reduce prescription drug costs is to allow for importation of FDA-approved prescription drugs from other industrialized nations like Canada, Japan, Australia, New Zealand, and European countries. Americans pay some of the highest prices for the same prescription drugs that are sold 33 to 55 percent less in other countries. Americans are now importing more than $1 billion in prescription drugs from Canada alone. In these tough economic times, and with equally safe but more affordable drugs just over the border, it is no wonder that Americans are going to such lengths to buy the prescriptions they need.

The Congressional Budget Office estimated in 2007 that allowing importation of prescription drugs would save consumers upwards of $50 billion. Just last year, the CBO reviewed their original estimate of government savings as a result of this policy, concluding that the government would nearly double its expected savings to over $19 billion.

We do a lot of things in Congress that leave our constituents scratching their heads. Well, now we have a chance to show them we are listening to them, that we understand their concerns, and that we want to bring down Federal spending while ensuring the prescriptions drugs they need are more affordable.

We can also do more to ensure affordable prescription drugs for Medicare beneficiaries by calling on the Secretary of Health and Human Services to negotiate drug prices for Medicare Part D enrollees. Mr. President, I opposed the legislation that created the Medicare Part D drug benefit because I did not believe the program would provide adequate financial relief for Medicare beneficiaries facing high prescription drug costs. This legislation actually included a provision which explicitly forbade the Secretary from negotiating with drug manufacturers on behalf of seniors' interests. We should have done better for our seniors. And they are living with the consequence of that decision today--with ever-rising prescription drug costs.

The health reform law will provide some relief, particularly for the dreaded ``donut hole'' of Medicare Part D. But health reform does not speak to the other glaring shortfall of the Medicare Part D program-- that the government is prohibited from negotiating for better drug prices for beneficiaries.

Negotiating on behalf of beneficiaries is hardly a radical idea, Mr. President. The Department of Veterans Affairs, VA, negotiates on drug prices and spends considerably less than the Medicare program on the same drugs. The National Committee to Preserve Social Security and Medicare released a study that found that VA drug prices are, on average, 48 percent lower than Medicare Part D prices for the top 10 prescribed drugs. NCPSSM estimates that billions could be saved annually by requiring the Secretary to negotiate drug prices for Medicare Part D. With the government on the hook for over $50 billion in drug costs for Part D alone, it is simply irresponsible to not aggressively seek new savings from negotiating prices. Focusing on lowering the price of prescription drugs rather than subsidizing insurance and pharmaceutical companies will not only provide relief for the sick, but will save taxpayer dollars.

Changing how we purchase prescription drugs by allowing importation from industrialized countries and negotiation on pricing for Medicare Part D is a clear and simple way to reduce prescription drug costs, reduce government spending, and keep Americans healthier. I am thankful for the leadership that my colleagues have shown in introducing legislation on these topics, and add my voice, and my bill, to theirs in our combined effort to answer the demands of our constituents.

Mr. President, today Senator Tom Harkin, Chairman of the Senate Health, Education, Labor and Pensions Committee and I are introducing the Dietary Supplement Full Implementation and Enforcement Act of 2010, which is similar to the legislation we introduced in the 108th Congress.

Our goal in introducing this commonsense bill is to ensure that the Food and Drug Administration properly implements and enforces existing dietary supplement laws--namely the 1994 Dietary Supplement Health Education Act, DSHEA, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. This is important to protect the 150,000,000 Americans who regularly take dietary supplements and to remove ``bad actor'' companies from the marketplace.

This issue is extremely important because the laws already on the books are sufficient if the FDA has the resources and the will to fully enforce them. Indeed, previous FDA commissioners--Dr. Jane Henney, Dr. Mark McClellan, Dr. Lester Crawford and Dr. Andy von Eschenbach--have all stated as much in Senate hearings and in my meetings with them. Moreover, current FDA Commissioner Dr. Margaret Hamburg has assured me that she will work with me to ensure these laws are enforced.

Bottom line: the FDA already has the regulatory authority it needs under current law.

That is why I will not support any changes to existing dietary supplement laws until the legislation we are introducing today has been approved by both the House and the Senate and signed into law by the President. We also need to ensure this legislation is fully funded by this Congress and enforced by the FDA with the full backing of this Administration. It is important to give FDA the resources it needs to accomplish both tasks. The legislation that we are introducing today will do just that.

Senator Harkin and I have asked our colleagues on the Senate Appropriations Committee to provide the FDA with the funds it needs to fully implement DSHEA. We will continue to work diligently to help them succeed in that task.

As you know, DSHEA clarified the FDA's regulatory authority over dietary supplements while ensuring that Americans will continue to have access to safe dietary supplements and helpful information about these products. It passed the Senate twice by unanimous consent. The legislation we are introducing today includes a Sense of the Congress and outlines the methods the FDA should use to better implement and enforce laws related to dietary supplements. It further requires the dietary supplement industry to redouble its efforts to comply with the law and cooperate with the FDA.

To provide the FDA with the resources necessary to regulate compliance with dietary supplement laws, this bill directs the agency to use part of its 2010 Fiscal Year Budget for that purpose. It also authorizes the National Institutes of Health's Office of Dietary Supplements to expand research and develop more consumer information on dietary supplements.

Furthermore, the legislation requires the Secretary of Health and Human Services (HHS) to submit an annual report to Congress, starting no later than January 31, 2011, regarding HHS activities on dietary supplements. Finally, it directs the FDA to issue its New Dietary Ingredient (NDI) guidance, as recommended by the General Accountability Office, within 180 days and requires the FDA to share any information on tainted NDI with the Drug Enforcement Agency.

It is my sincere hope that all my colleagues will support this effort to ensure that dietary supplement consumers and manufacturers are protected and properly regulated. Our constituents deserve no less.

This legislation is supported by the Major League Baseball and NFL players associations, the Natural Products Association, the United Natural Products Alliance, Council for Responsible Nutrition, American Herbal Products Association and the Consumer Health Care Products Association.

I hope that each of you will see the wisdom in supporting this measure.

Mr. President, I ask unanimous consent that letters of support be printed in the Record.

Mr. President, today I am introducing the Veto Wasteful Spending and Protect Taxpayers Act of 2010 which establishes a constitutional line-item veto by creating an expedited rescissions process.

Yesterday, the Obama administration unveiled the Reduce Unnecessary Spending Act of 2010. This legislation is very similar to my proposal which I first introduced in 2006. They both provide for an expedited rescission process. The line-item veto is not a panacea for record level deficits, but it will provide the President with the necessary tool to reduce wasteful spending.

Both bills will give the President the ability to target projects that have been added in spending bills that benefit special interests or are not necessary. I applaud President Obama for addressing this issue.

I have been a long-time advocate of the line-item veto. It has been a successful tool at the state level and I think it can effectively reduce spending on the Federal level. We have made progress with earmark reform and I think expedited rescission would result in further spending reductions.

The major difference between my legislation and the Administration's proposal is that the Veto Wasteful Spending and Protect Taxpayers Act of 2010 would allow the President to suspend and propose cancellation for discretionary spending, new direct spending, and limited tax benefits. The Reduce Unnecessary Spending Act of 2010 focuses on discretionary spending. If we really want to tackle wasteful spending, I think we need to look at new entitlement spending and limited tax benefits, not just discretionary spending.

In 1996, the Congress passed and President Clinton signed into law the Line Item Veto Act, P.L. 104-130. Two years later, however, in Clinton v. City of New York the Supreme Court concluded that the method used to give the President line-item veto authority was unconstitutional. The Court noted that presidents may only sign or veto entire acts of Congress. The Constitution does not authorize presidents to enact, to amend or to repeal statutes.

We can restore the line item veto and be consistent with the Constitution. The key difference between what I am proposing and what the Supreme Court struck down is the legal effect of the President's actions. The Line Item Veto Act allowed the President to cancel provisions in their entirety, but the Supreme Court rejected this arrangement. My legislation will empower the President to suspend provisions until the Congress decides to approve or disapprove the suspension of that provision with an up or down vote. The provisions are not cancelled out of the legislation. I believe this change addresses the Supreme Court's concerns. My legislation also does not include a mechanism which allows a provision to be suspended for a lengthy time period.

Under the Veto Wasteful Spending and Protect Taxpayers Act of 2010, the President has 10 calendar days to submit to Congress a special message. The President may transmit two messages per bill, but a provision may only be proposed for suspension or cancellation one time. The House and Senate would consider the special message under a special process which does not allow for amendments or motions to strike.

I believe that the line-item veto is a valuable tool that should be made available to any President regardless of political party. For this reason, the Veto Wasteful Spending and Protect Taxpayers Act of 2010 is permanent, rather than sunsetting after a few years.

It is time to reinstate the line-item veto. I look forward to working with my colleagues on both sides of the aisle to return to the President the authority to rein in wasteful spending.