Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 03, 2007)

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PEACE IN SUDAN

Mr. DURBIN. Mr. President, I rise today to once again address the ongoing violence in Darfur, Sudan.

Hundreds of thousands of people have been killed in that terrible genocide, and millions have been driven from their homes.

This week, the International Criminal Court has issued its first arrest warrants for these murderous crimes. The ICC issued warrants for the arrest of Sudan's so-called Humanitarian Affairs Minister Ahmed Haroun and against a jingaweit militia leader known as Ali Kushayb. Sudan says there is no need for such a trial and that its own courts are capable of prosecution. This is the very same Government that has helped orchestrate this campaign of violence, a government wheree courts are more likely to prosecute rape victims than the men who attack them. That is why we need international action in response to these crimes against humanity.

Mr. Haroun, who today serves as Sudan's Minister for Humanitarian Affairs, was in charge of Darfur in 2003 and 2004, at the height of the killing.

The jingaweit commander, who is the second man named in the warrant, commanded thousands of militia members and is accused of promoting rape and torture as part of his war strategy. The Sudanese Government claims he is in custody, but witnesses have told reporters that in reality he has been traveling in Darfur under police protection.

These arrest warrants are a significant, if small, step toward justice, but there is so much more the world must do to bring peace, justice, and security to the people of Darfur.

Recently, President Bush delivered a speech at the Holocaust Museum, promising that unless Sudan agreed to a full-scale peacekeeping mission and took other steps, then the United States would expand unilateral sanctions against the Sudanese--in the President's words--``within a short period of time.'' The President also stated he would press for multilateral sanctions through the United Nations. Both are important steps. I wish they had been taken far earlier, but they are still welcome steps.

Deputy Secretary of State John Negroponte recently returned from Sudan. The report on his trip was not encouraging. He told us that Sudan's President Bashir continues to stand in the way of a full-scale U.N. mission. He also said Bashir is not taking steps to disarm the militia that have terrorized villages in Darfur, with the Khartoum Government's tacit, if not open, support.

I know President Bush had planned to announce new sanctions at his speech at the Holocaust Museum. He agreed to delay implementing further measures in response to a strong personal request from the Secretary General of the United Nations.

We cannot solve Darfur alone. It will take many nations. I understand why President Bush felt compelled to give the United Nations an opportunity. But the world cannot wait long, and the people in Darfur certainly cannot be asked to wait any longer. The violence there is entering its fifth year.

A new report by the International Crisis Group, a nongovernmental organization working to prevent conflict across the world, spells out the urgency. This report states that combat in Darfur is rising, and the Sudanese Government continues to rely on aerial bombardment and raids by the jingaweit militia as its tactics of choice against its own people.

The Crisis Group report also spells out the complexity of what is happening there. The report states:

Darfur is the epicenter of three overlapping circles of conflict.

First and foremost, there is the four-year-old war between the Darfur rebel movements and the government, which is part of the breakdown between Sudan's centre--the National Congress Party in Khartoum, which controls wealth and political power--and the marginalized peripheries.

Secondly, the Darfur conflict has triggered a proxy war that Chad and Sudan are fighting by hosting and supporting the other's rebel groups.

Finally, there are localized conflicts, primarily centered on land tensions between sedentary and nomadic tribes.

The regime has manipulated these to win Arab support for its war against the mostly non-Arab rebels.

International interests, not least the priority the U.S. has placed on regime assistance in its ``war on terrorism'' and China's investment in Sudan's oil sector, have added to the difficulty in resolving the conflict.

This report calls for implementation of a full-scale peacekeeping mission and the need to revitalize the peace process itself. Peacekeeping troops can help keep civilians protected. International mediators from the African Union and the United Nations must also help the rebel groups and the Sudanese Government reach a more broad-based peace agreement. The first requirement, however, is getting peacekeepers into Darfur. Conflict is rising. The humanitarian space is shrinking. It is becoming harder and harder for many relief groups to reach those in need.

In testimony before the Senate Foreign Relations Committee on April 11, Special Envoy to Sudan Andrew Natsios stated that Secretary General Ban Ki-moon had requested a 2- to 4-week window in order to pursue diplomatic negotiations with Khartoum before any additional measures were taken. May 11, just a few days away, will mark a full month since Mr. Natsios's testimony. On that date, if Khartoum has not acted to take the necessary steps toward peace, I hope President Bush will launch expanded, hard-hitting U.S. sanctions and seek to pass a United Nations Security Council resolution with meaningful multilateral sanctions.

We need to strike out economically where it will hurt--against Sudan's oil industry. And I hope that China, which sits as a permanent member of the Security Council and represents Sudan's biggest oil customer, will join in our efforts. China buys 70 percent of Sudan's oil, and reportedly the Khartoum Government spends 60 to 80 percent of its oil revenue on its military. The Sudanese Government uses that military against its own people, especially in Darfur.

As a rising power, as the host of the next Olympics, and as a member of the Security Council, it really is China's responsibility to use its influence to convince Sudan to accept the full-scale peacekeeping mission that is really

needed. China has helped convince Sudan to say it will accept 3,000 U.N. peacekeepers, but far more than that is needed, and Beijing can play a pivotal role in bringing peace to Darfur. The statement made by the Chinese Government a few days ago was encouraging, but it was a very modest statement when you consider the magnitude of this genocide.

Today, there are fewer than 7,000 underequipped African Union peacekeepers spread across Darfur--an area the size of Texas but Texas without roads or infrastructure.

The cause of Darfur has captured the hearts of millions of Americans. This past weekend, in Chicago and in cities across the Nation and around the world, thousands of people gathered in support of the people of Darfur and in support of efforts to divest from companies that invest in Sudan.

I should also mention that this same weekend, at Soldier Field in Chicago, thousands of young people gathered in support of the ``Invisible Children'' of Uganda. These children have also been victimized by years of war, and indeed the conflicts in Northen Uganda and Sudan are intertwined.

For years, the Sudanese Government has supported and assisted the Lord's Resistance Army, which has terrorized northern Uganda.

One of the focal points of the Sudan rally last weekend was to support legislation introduced by my friend, State Senator Jackie Collins of Chicago. She is a wonderful leader on this issue. She has shown such persistence and courage, pushing for divestment so that Illinois, my home State, can have maximum impact to end this genocide. Her bill would divest State pension funds and other investments that add to the coffers of the Sudan Government.

At the rally, participants also supported efforts here in Congress, which Senator John Cornyn and I have introduced, to express Federal support for States, universities, and others that choose to divest.

This movement is expanding, not just here at home but abroad as well. Rolls-Royce has announced it is withdrawing from Sudan. According to media accounts, including the Associated Press, the Ford Motor Company, which produces Land Rovers, will no longer sell Land Rovers in Sudan. According to these press accounts, Ford made this decision after the Securities and Exchange Commission sent the company an inquiry asking about reports that some Land Rovers may have been used by military or paramilitary organizations.

This Saturday, Berkshire Hathaway, one of the largest and most respected investment firms in the country, will convene a shareholder meeting. Warren Buffett, who runs Berkshire Hathaway, has agreed to put the divestment question on the agenda.

The divestment movement was launched on college campuses. It is now reaching the boardrooms of major corporations and the agenda of shareholder meetings. Divestment is one tool among many, along with U.S. and U.N. sanctions, increased penalties for violations of U.S. law, stepped up engagement by China, and a commitment to reengage the peace process itself.

I have made these points before, but we must not let the Sudanese Government think that the often limited American attention span will wander away from Darfur. We will not blind ourselves to genocide, and we will not grow fatigued by more news stories of suffering in this distant place. We must do, in every way possible, what we can do as individuals, as Members of Congress, and as Americans who care, Americans who have said when it comes to a genocide: Never again.

Mr. President, I yield the floor.

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Mr. DURBIN. Mr. President, I rise today to discuss two amendments that I have filed to this bill, Nos. 1027 and 1023. I do not intend to offer them at this time, but they raise important issues that I would like to highlight.

I want to begin by thanking the chairman, Senator Kennedy, and ranking member, Senator Enzi, for their hard work on this bill. Together, we made significant progress yesterday by adopting an ambitious amendment to improve our food safety system for both humans and pets.

I also want to thank Senators Kennedy and Enzi for agreeing to work on a comprehensive food safety package. That commitment is not taken lightly, and I look forward to working with them on this comprehensive package.

Although we took great strides yesterday with respect to food safety, there are two important areas where the FDA is limited in its ability to protect our food supply. These weaknesses have been exposed in recent recalls: the E. coli spinach contamination; the peanut butter recall; and, most recently, the expanding pet food recall that has entered, or at least come very close to entering, the human food supply.

The first weakness is that the FDA lacks the authority to issue a recall or pull defective products from shelves to protect consumers.

This is surprising to many people, but here is a quote from the FDA website, summarizing its recall authorities:

The manufacturers or distributors of the product carry out most recalls of products regulated by FDA voluntarily. In some instances, a company discovers that one of its products is defective and recalls it entirely on its own. In others, FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply.

This is true. Most often, companies comply, and there are penalties for failing to recall.

However, sometimes companies recognize that they have a problem but choose not to recall a product because they are afraid of upsetting consumer confidence or losing market share. The FDA has reported multiple instances of firms failing to recall or recall in a timely fashion.

In the pet food recall, companies have time and time again expanded their recalls, and the process has lasted more than 6 weeks. Just yesterday Menu Foods, the first company to recall on March 16, 2007, expanded its recall yet again. This recall was for products made during the same period of time as the other recalled products announced on March 16. Menu Foods has also announced an expanding date range of contaminated product.

This same weakness was on display in 2002 in the ConAgra beef recall.

Unfortunately, without the power of mandatory recall, the FDA is in a weaker position to force companies to announce recalls quickly or to thoroughly study the extent of a recall. The result is slow, uneven, voluntary recalls that leave consumers at risk.

The Consumer Protection Safety Commission, the EPA, and even the FDA with respect to infant formula have recall authority. Why, then, does the FDA not have that authority for the other foods it regulates?

This authority would expedite the speed and thoroughness of voluntary recalls, protect consumers, and protect industries against bad actions that threaten consumer confidence.

A revision of recall authority is very much overdue, and my amendment would provide that. I hope that this issue will be seriously considered in the broader package of food safety reform.

The second area I would like to raise is the lack of resources for the FDA's food safety efforts.

One of the most significant aspects of the pet food recall and other food contaminations we have observed in recent years is that the FDA is struggling with its increasing responsibilities and its current level of resources.

If we look at the increasing volume of food that the United States imports each year, it is clear why this is a problem. In 2003, the United States imported $45.6 billion of agricultural products. Today, that number is $64 billion. Agricultural imports from China alone have nearly doubled from $1.2 billion to $2.1 billion.

Much of the responsibility for overseeing and inspecting the safety of these imports rests with the FDA. However, due to fairly flat budgets, the overall number of inspectors looking at these shipments and at domestic food processors actually has decreased from 2003 to the present from a level of more than 3,000 inspectors to about 2,700 inspectors today.

Less than 1.5 percent of these imports are inspected by the FDA, and the FDA lacks the resources and authorities to certify the standards of our trading partners.

This situation presents an economic, public health, and bioterrorism risk to the United States. The CDC estimates that 76 million Americans become sick from food borne illnesses each year. More than 300,000 are hospitalized and 5,000 die each year.

We clearly need to review the FDA's funding to ensure it has the resources necessary to safeguard the 80 percent of our food supply that it is responsible for regulating.

The FDA office that is responsible for food imports, the Center for Food Safety and Nutrition, is also responsible for regulating $417 billion of domestic food and $59 billion of cosmetics. This includes points of entry into the United States, approximately 300,000 food establishments, and 3,500 cosmetic firms. President Bush has requested only $467 million for fiscal year 2008 for this department to regulate all of this activity, and only $312 million of that amount would be for inspectors.

Therefore, I am pursuing two tracks in this area. Last week, I sent a letter to Chairman Kohl and Senator Bennett of the Agriculture Appropriations Subcommittee, which funds the FDA, asking for a significant increase in the level of funding for the FDA Foods Program. I hope my colleagues will join me in this effort.

Secondly, the amendment I have filed to this bill would direct the Secretary of Health and Human Services to study the feasibility of a user fee program for foods that would incorporate lessons learned from the prescription drug user fee program. This study would present various options on creating a user fee program for foods that could increase the resources and capabilities of the FDA in this area. Specifically, it calls for legislative recommendations that analyze the expected revenues for the FDA, as well as the costs to industry by sector.

For the sake of improving food safety, I think it is vital that we explore the various options for providing the FDA with adequate resources.

Again, I will not offer this amendment at this time, but I hope my colleagues will join me in supporting such a study in the future as Congress deals with broad food safety reform.

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