STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - August 03, 2006)
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Mr. KENNEDY. Mr. President, Senator Smith and I have sent a bill to the desk to address the heart-wrenching crisis in Darfur and support the peace process there, and we look for its early consideration.
The horrifying violence in the Darfur region of Sudan was recognized by Congress and the Bush administration as genocide over 2 years ago, and it continues unabated today. However, rays of hope for peace can be seen on the horizon. On May 5, the Government of Sudan and the main rebel group, the Sudan Liberation Movement led by Minni Minnawi, agreed to a plan that, if implemented, could bring peace to Darfur.
The plan calls for an immediate cease-fire and requires the Government of Sudan to neutralize and disarm the Janjaweed militia, the gunmen supported by the government who have been conducting a bloody campaign to forcibly displace non-Arab tribes from Darfur.
The Darfur Peace Agreement is an opportunity we need to seize. To do so, greater international pressure on the Sudanese government will be required in order to improve the prospects of effective implementation. Developments since its signing indicate that the present level of international pressure isn't enough.
Three months have passed, but the Sudanese Government has done little to take the most important step in the peace plan--disarming the Janjaweed. Khartoum's past record is not encouraging. It has pledged to disarm the Janjaweed on previous occasions but then failed to follow through. This reluctance is not unexpected in light of the government's cynical use of the Janjaweed to exercise power in the Darfur region.
In recent months, the violence in Darfur has spilled over into neighboring Chad. The two governments each support armed groups opposed to the other. Sudanese helicopters and planes attack innocent villagers in Darfur, despite a United Nations order not to fly over Darfur.
The African Union Mission in Sudan, which has 7,000 peacekeepers in Darfur, has made a valiant effort to provide security and assist the people of Darfur. Nonetheless, the African Union peacekeepers are not able even to defend themselves, much less the two million refugees and internally displaced persons fleeing the violence. This mission is obviously unprepared and ill-equipped to press for and verify the implementation of the May 5 peace agreement.
Sudan appears to be waiting to see whether the international community will again just lament the crisis and make hollow threats, or is now ready and willing to take concrete steps. As one high-ranking Sudanese Government official said to a Boston Globe reporter, ``The United Nations Security Council has threatened us so many times, we no longer take it seriously.'' It is time for the United States and the international community to let the Sudanese Government know that this time we expect Sudan to carry through on its commitments in the Darfur Peace Agreement.
Fortunately, the international community has already taken initial actions to support the May 5 Peace Agreement. The African Union and the United Nations are planning for the transfer of peacekeeping responsibilities from the African Union to the United Nations. In addition, NATO has begun planning on how to support a U.N. peacekeeping mission, and the European Union hosted a conference in July on assistance for Darfur.
Although the international community has signaled support for the Darfur Peace Agreement, Khartoum has been dragging its heels. In particular, it has not yet agreed to allow a U.N. peacekeeping mission into Darfur. The international community must strengthen its effort to persuade the Sudanese Government to comply with the agreement and permit the U.N. peacekeepers in Darfur.
One of the tragic outcomes of the Darfur violence is an alarming humanitarian crisis. More than 3 million people in Darfur are dependent on humanitarian assistance for survival. The violence in Darfur has forced millions to flee from their homes. The U.N. Office for the Coordination of Humanitarian Assistance reports that significant needs for health, food and water, and sanitation are not being met in Darfur. The World Food Program warns of a $400 million shortfall in the funds it now has for Sudan. Because of the shortages in food relief, the refugees are receiving only partial rations.
The children suffer most. One in four children in Darfur die before the age of five. The most needy frequently remain hidden, because insecurity in the region prevents them from making the dangerous trip to international relief centers.
The United States has been the largest single donor of humanitarian assistance to the people of Darfur, and we must continue our effort in order to give the people of the region much-needed aid. We must do more to encourage the international community to do so as well.
Sadly, the continuation of violence in the region has severely hindered humanitarian aid efforts. In the past 6 months, aid groups in eastern Chad have lost 26 vehicles to armed hijackers. One UNICEF worker was shot and nearly killed. It is unfair to put relief agencies in a situation where they must either risk having their aid workers murdered or raped, or pull out and leave thousands in Darfur to die. U.N. Secretary General Kofi Annan said of this crisis, ``Giving aid without protection is like putting a Band-Aid on an open wound.''
To give peace the best chance of taking hold, peace, the Sudanese Government must be persuaded to implement its commitment to neutralize and disarm the Janjaweed. The Sudanese can be influenced by what the rest of the world does. Sudan is not an isolated, remote land. It is the largest country in Africa, and has significant economic and political ties to the rest of Africa and the world.
Now is the time for the United States, in concert with other countries, to act on Darfur. This is why Senator Smith and I have introduced legislation to urge the Sudanese parties to honor their commitment in the peace accord. The bill also helps to address the unmet humanitarian needs in Darfur.
At its core, the legislation is intended to encourage greater international pressure on the Government of Sudan to fulfill its obligations in the peace agreement and to allow U.N. peacekeepers into Darfur.
In preparing this legislation, we have worked closely with the NGO community of experts. Groups such as the International Crisis Group, Refugees International, Save Darfur Coalition, the Hebrew International Aid Society, the American Jewish Committee, the American Jewish World Service, and Physicians for Human Rights have endorsed it. I will ask that the letters of endorsements that I have submitted be printed in the RECORD.
The legislation assigns to the Presidential envoy for Sudan the responsibility for supporting the Darfur peace process and, together with the international community, to press the Sudanese parties to implement the agreed-upon ceasefire and disarm the Janjaweed militia.
It calls on the Government of Sudan to immediately allow a U.N. peacekeeping force to enter Darfur and to implement the Darfur Peace Agreement.
It calls on NATO to enforce the no-fly zone over Darfur, if requested by the U.N., and to provide airlift, and logistical and intelligence support to the peacekeepers.
It calls on the international community to act promptly to meet the outstanding humanitarian assistance needs. We must do our part too. The legislation authorizes $150 million in additional funds for each of the next 5 fiscal years to meet these needs.
Under the legislation, the President will report on whether the Sudanese Government is implementing the peace agreement and has agreed to allow a U.N. peacekeeping mission to enter Darfur. If so, then the Presidential special envoy for Sudan will be requested to develop recommendations to advance the peace process. If the Sudanese Government refuses, then the President will impose sanctions targeted on the leaders of Sudan, urge the international community to do the same, and continue to oppose normalization of its relations with Sudan.
In addition, the bill requires reports from the Commerce Department identifying companies investing $5 million or more in Sudan and a listing of the assets of Sudanese leaders in the United States and elsewhere.
With so much other violence erupting in the world, we must not ignore the crisis in Darfur. Without international action, the genocide will go on. The Sudanese Government will balk or move slowly on disarming the Janjaweed and bringing an end to the violence. Experts estimate that since the conflict in Darfur began in 2004, up to 300,000 people have been killed, and an estimated 1.9 million have been displaced. Every day that we fail to act, those shameful numbers will increase.
I urge my colleagues to support this legislation.
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Mr. KENNEDY. Mr. President, Senator ENZI, chairman of the Senate Health, Education, Labor, and Pensions Committee, and I are introducing the Enhancing Drug Safety and Innovation Act of 2006. The goals of this legislation are to enhance the Food and Drug Administration's authority over the safety of prescription drugs after they are approved; to encourage innovation in medical products; to improve access to clinical trials for patients and ensure that the doctors and patients learn about the results of clinical trials involving the drugs they prescribe and use; and to improve the screening of members of FDA's scientific advisory committees to avoid conflicts of interest.
The withdrawal of the drug Vioxx from the market nearly 2 years ago showed us once again that all prescription drugs have risks, many of which we may not know about when a drug is approved or even for years after approval. That is why we need a more effective system to identify and assess the serious risks of drugs, inform health care providers and patients about such risks, and manage or minimize these risks as soon as they are detected.
Our bill will require every drug to have a risk evaluation and mitigation strategy, or REMS, when it is approved. For many drugs, the REMS will include only the drug labeling, reports of adverse events, a justification for why only such reporting is needed, and a timetable for assessing how the REMS is working.
The FDA will be able to include additional requirements for a drug that poses serious risks, such as by requiring the drug to be dispensed to patients with labeling that patients can understand, that the drug company have a plan to inform health care providers about how to use the drug safely, or that a drug should not be advertised directly to consumers for up to 2 years after approval. If a serious safety signal needs to be understood, FDA can require further studies or even clinical trials after the drug is approved. Enhanced data-collection and data-mining techniques will help identify risk signals earlier and more thoroughly.
For a drug with the most serious side effects, FDA will be able to require that its REMS include the restrictions on distribution and use needed to assure its safe use.
The FDA will be able to impose any of these requirements at the time a drug is approved, and the agency can also modify the labeling or otherwise alter a drug's REMS after the approval. The drug's manufacturer will propose the REMS, or modifications to it, and the FDA and the company will try to work out an adequate REMS. If the agency and the company cannot agree, the agency's Drug Safety Oversight Board can review the dispute and recommend a resolution to senior FDA officials, who will make the final decision.
Civil monetary penalties are added to FDA's traditional enforcement tools to ensure compliance. Drug user fees will be used to review and implement the program.
The bill formalizes and makes mandatory what is now only informal and voluntary. Our intent is not to change standards for approving drugs but to ensure that the FDA has the ability to identify, assess, and manage risks as they become known. Better risk management will mean that drugs with special benefits for some patients will remain available, despite their serious risks for other patients, because FDA can better identify the risks and minimize them.
The bill helps to improve drug safety in other ways as well. The Reagan-Udall Institute for Applied Biomedical Research will be a new public-private partnership at the FDA to advance the agency's Critical Path Initiative, which is intended to improve the science of developing, manufacturing, and evaluating the safety and effectiveness of drugs, biologics, medical devices, and diagnostics.
The institute will be supported by Federal funds and by contributions from the pharmaceutical and device industries. Philanthropic organizations will be able to supplement Federal support. The institute will have a board of directors and an executive director, and will report to Congress annually on its operations.
The bill will also expand the public database at NIH to encourage more patients to enroll in clinical trials of drugs. This database would build on the current systems and would include late phase II, phase III, and all phase IV clinical trials for all drugs.
A second, publicly available database would include the results of phase III and phase IV clinical trials of drugs, with the possibility that late phase II trials would be added later. Posting of results could be delayed for up to 2 years, pending the approval of the drug or the publication of trial results in a peer-reviewed journal. The public needs to know about the results of clinical trials on drugs. Tragically, such information was not adequately available for the clinical studies of antidepressants in children.
Posting information in the clinical trials registry and the clinical trials results database will be requirements for Federal research funding and for drug review and approval by the FDA. Both the FDA and the Inspector General Office of the Department of Health and Human Services would review the content of submissions to the results database to ensure they are truthful and nonpromotional. These Federal requirements would preempt State requirements for clinical trial databases.
Finally, the bill will improve FDA's process for screening advisory committee members for financial conflicts of interest. The agency relies on its advisory committees to provide independent, expert, nonbinding recommendations on significant issues. Ideally, committee members should be free of any financial ties to the companies affected by an issue before a committee. But at times, there may be no individual without financial ties to such companies--for example, when the issue involves a rare disease or a cutting edge medical technology. In these cases, the FDA must be able to grant a waiver to allow an individual with essential expertise to serve on the committee. The bill will require the agency to seek qualified experts with minimal conflicts, clarify how it makes waiver decisions, and disclose those decisions at least 15 days before a committee meeting.
Our bill is a comprehensive response to drug safety and other important issues involving prescription drugs and other medical technologies. I commend Chairman ENZI and his dedicated staff--especially Amy Muhlberg--for working closely with us on this proposal, and I urge our Senate colleagues to support it.
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