Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006

DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2006 -- (Senate - October 26, 2005)

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Mrs. MURRAY. Mr. President, I rise this evening to offer an amendment that really need not be offered. In fact, each time I come to the floor of the Senate to talk about Plan B and the FDA, I hope it will be the last time. I continue to hope that the FDA or Health and Human Services will do the right thing and finally put science and safety and efficacy over politics. Unfortunately, over the course of the past several years, as you can see by the timeline shown behind me, I, along with millions of Americans, have been disappointed time and time again.

I have always supported a strong and independent Food and Drug Administration. It is the only way in which the FDA can truly operate effectively and with the confidence of American consumers and health care providers. Americans have to have faith that when they walk into their local grocery store or their local pharmacy, the products they purchase are safe, effective, and that their approval has been based on sound science.

They have to be assured that those decisions were not based on political pressure or pandering to interest groups. That is why the application process for Plan B emergency contraceptives has been so troubling to me and many others.

Back in December of 2003, almost 2 years ago, the FDA's own scientific advisory board overwhelmingly recommended approval of Plan B's over-the-counter application by a vote of 23 to 4. But the FDA has not adhered to its own guidelines for drug approval and continues to this day, after all of these actions, to drag its feet.

In fact, Alastair Wood, who is a member of the advisory panel, said:

What's disturbing is that the science was overwhelming here, and the FDA is supposed to make decisions based on science.

It is obvious to me and to many of my colleagues--and to millions of American women and men--that something other than science is going on at the FDA. It is far past time to get to the bottom of it. That is why tonight I am offering this amendment which will shift $3 million from the Office of the Secretary to the Office of the Inspector General at the Department of Health and Human Services. This funding will help the inspector general's office to investigate potential mismanagement at the FDA. This investigation will be separate from ongoing investigations of the former Commissioner, Lester Crawford, and it will include, but not be limited to, over-the-counter application for Plan B.

Let me be clear: The men and women of the FDA work very hard. They adhere to the principles of science. They do a job that all Americans can be proud of. But their hard work is being undermined and it is overshadowed by the Agency's own leadership. If the leadership at the FDA and HHS don't take steps to restore the confidence of American consumers in the FDA's ability to promote safe and effective treatments, then Congress has a duty to step in. The health and well-being of the American people should not blow with the political winds. Caring for the people we represent is an American issue, and part of that goal is reassuring that Americans have access to safe, effective medicines in a timely fashion.

Time and time again, I, along with my colleague, Senator Clinton of New York, and others, have asked for a decision on Plan B. We have not dictated that we want a yes. We have not dictated that we want a no. We have simply said: We want a decision. This continued foot dragging--day after day, month after month, year after year--is unusual, unwarranted, and unprofessional. This continued delay goes against everything the FDA's own advisory panel found nearly 2 years ago: that Plan B is safe and it is effective and should be available over the counter. There is no credible scientific reason to continue to deny increased access to this safe health care option, but there is even less reason to deny an answer.

This is not the last word on this issue. The problem with politics subverting the FDA's adherence to science and its integrity is so profound and so urgent, I intend to use every tool available to me as a Senator to make sure that this discussion about our priorities and our future is not lost.

I ask my colleagues to do what we tell the FDA to do, which is to make decisions based on science and safety and efficacy true, and we don't turn the gold standard we have at the FDA into a mockery. It would be a disservice to every citizen, every American who walks into a drugstore and counts on the fact that when they buy a drug over the counter or a prescription, they know it is safe and effective.

This is an urgent matter. That is why I am on the floor to offer my amendment, which will simply shift money from the Office of the Secretary to the Office of the Inspector General, so we can get to the bottom of it.

I urge my colleagues to support the amendment. I yield the floor.

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