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Kennedy On Cloture Vote On FDA Revitalization Bill

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A week ago, my friend, Senator Enzi, and I stood on this same spot and began the debate on our drug safety legislation. During the past week, we have made much progress in addressing the priorities of the American people. The Senate has chosen to add a major proposal on food safety to our legislation. Other amendments will be included later this afternoon, on important issues such as direct to consumer advertising, citizens petitions, and many more.

That we have reached agreement on such a broad range of complex and difficult policy questions is a tribute to our colleagues' willingness to work with us and with the Senate to come to agreement on matters of great importance. I commend all of our colleagues and their staffs for the long hours and hard work that went into crafting these proposals.

Safety is at the core of this bill. FDA ought to be the gold standard for safety, but its luster has been tarnished by failures to protect the American people from unsafe drugs.

The American public was rightly shocked to know that the arthritis drug Vioxx was allowed to stay on the market for 5 years even though it nearly doubled the risk of heart attack and stroke. Antidepressants used by millions were found to increase the risk of suicide in adolescents. Americans have needlessly been put at risk, and they are demanding action from Congress.

FDA now lacks clear legal authority to protect public health. When lives are on the line, doctors should be making the crucial decisions, but because FDA's authority is so unclear, they first must call the lawyers for their opinion as to whether they can act. When patients are in danger, FDA shouldn't have to wait to get legal opinions to decide how to protect health. It should be able to act, and our bill gives them that authority.

Our legislation gives FDA the ability to require post-market studies to investigate risks. It allows FDA to require label changes rather than relying on voluntary requests to companies to do the right thing. It allows FDA to require special training for physicians or even to restrict the use of a drug where there is no other way that it can be used safely. We require review of advertising to see that it accurately depicts the risks and effectiveness of drugs, and we devote funds from the user fee program to these public health needs.

I have fought for these protections not for a week, not for this Congress, but for decades. In 1979, I introduced the Drug Regulation Reform Act, to give FDA the clear authority to protect public health. The Senate approved it, but the House failed to act, and I have worked ever since to see that FDA can take action to protect public health where needed. We have waited long enough for action.

Our legislation includes other important provisions too. Senator Dodd's proposal to encourage development of new medicines and medical devices for children is a strong part of the original legislation, as is Senator Clinton's bill to give HHS the authority to require studies of drugs in children when the incentives are ineffective.

During our committee's consideration of the legislation, many members brought forward important recommendations to strengthen the proposal. Senator Mikulski contributed major provisions on improving transparency at the FDA, and strengthening its scientific integrity.

As we moved to the Senate floor, other colleagues came forward with their ideas that we were able to include either in the base bill or in the package of amendments we will be adding shortly.

Senator Durbin contributed his important proposals on improving the safety of the food supply. Senator Stabenow, Senator Brown, Senator Lott, Senator Thune, Senator Hatch and Senator Coburn developed a proposal on citizens petitions that will end the abuse of the system while preserving FDA's ability to review those petitions that have public health merit. Senator Roberts and Senator Harkin worked together successfully to solve the difficult issue of how to see that direct to consumer advertisements provide effective safety information to patients while meeting the stringent test of constitutionality. Senators Brownback and Brown contributed an innovative idea to encourage the development of new therapies for neglected diseases that affect many millions of the poorest citizens of the world. Senator Vitter has contributed a proposal on counterfeit drugs that will be included here today too.

All these, and many other proposals besides, will be lost if this bill fails. A bill with such strong and effective reforms to improve the lives of American families should pass by acclamation, but instead, the Republican leadership has held it hostage to a vote on an amendment that will gut the essence of the Dorgan?Snowe reimportation amendment.

But all of this hard work, all of this careful consideration, all of this important progress for American families is threatened by one thing, and one thing alone, the intransigence of a Republican leadership that has ignored all efforts to find a way for the Senate to consider legislation on reimportation, time after time and year after year.

Senator Reid, Senator Dorgan, and I have offered again and again to find a way to allow consideration of the reimportation bill to give it the straight up or down vote it deserves. We have made clear that the debate would include consideration of competing proposals and the Cochran amendment. We have been flexible in offering time for debate, in determining when the debate will occur, and on the amendments to be offered.

But each offer of flexibility has been met with rigid denial. Each offer to talk has been met with silence. Each offer to make progress for the American people has been met with obstruction from a determined minority bent on finding a way to stop this bill.

I believe that the American people deserve prescription drugs that not only are safer but that cost less, too. But the White House apparently is listening more to the big drug companies than to the American people. The White House says the President will veto this bill if it cuts the cost of prescription drugs. After all, that means lower profits for the pharmaceutical industry. Never mind that Americans are facing skyrocketing health costs. The Bush Administration's priority is to protect profits, not patients.

It is my hope that we can move forward to ensure the safety of our food and the safety of our medicines. We owe that to the American people. And if we must fight another day to lower the costs of prescription drugs by allowing Americans to buy cheaper drugs from Canada and other nations, then I stand with my Democratic colleagues to wage that fight. It is a fight that we will win because the American people urgently need relief from rising health care costs.

So I have concluded that the only answer for me is to support the Cochran amendment now, on this bill, so that we can continue the fight for safer medicines, pure food, and a stronger FDA.

The long battle for cheaper prescription drugs is not over. And it will not be over until we achieve the victory that the American people demand.

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