Appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, 2006-- Conference Report

APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES FOR THE FISCAL YEAR ENDING SEPTEMBER 30, 2006--CONFERENCE REPORT -- (Senate - November 02, 2005)

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Mrs. MURRAY. Mr. President, I rise this evening to talk about an issue that affects Americans all across the country, and that is the credibility of the FDA.

I thank Senator Bennett and Senator Enzi, who are both here, for their work in a bipartisan fashion on the language that was put into the Agriculture appropriations bill. I also thank Senator Kohl for his help.

Every time I come to the floor to talk about the FDA and plan B, I hope it will be the last time. I continue to hope that the FDA and HHS will do the right thing and put science, safety, and efficacy over politics. Unfortunately, over the past couple of years, 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 pharmacy or their local grocery store that the products they purchase are safe and effective and that their approval has been based on sound science, not on political pressure, not on pandering to interest groups.

That is why the application process for plan B emergency contraceptives has been so troubling to me.

Back in December 2003, 2 years ago, the FDA's own scientific advisory board overwhelmingly recommended approval of plan B over-the-counter application by a vote of 23 to 4. But the FDA has not adhered to its guidelines for drug approval and continues to drag its heels.

In fact, Alastair Wood, who is a member of that 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--to many of my colleagues--and to millions of American women that something other than science is going on now at the FDA, and it is far past time to get to the bottom of it.

That is why I am especially pleased that I have been able to secure bipartisan language in the Agriculture appropriations conference report that expresses the sense of both bodies of Congress that enough is enough.

The language simply says:

The conferees remain concerned about the legal and regulatory issues relating to approval of drugs as both prescription drugs and over the counter products, and urge the FDA to expedite rulemaking on this topic.

If the leaders of FDA and HHS refuse to take the steps to restore the confidence of the American consumers and FDA's ability to promote safe treatments, then Congress has to step in. The health and well-being of the American people should not blow with the political winds. Caring for our people is an American issue, and part of that goal is ensuring we have access to safe, effective medicines in a timely fashion.

How can we trust the FDA to move quickly on vaccines for global pandemics if they continue to operate the way they have on plan B?

Time and time again, I, along with Senator Clinton of New York and others, have asked simply for a decision on plan B. We have not asked for a yes or a no, just a decision. This continued foot-dragging is unusual, it is unwarranted, and it is unprofessional. This continued delay goes against everything the FDA's own advisory panel found nearly 2 years ago: that plan B is safe, 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.

Yesterday marked another deadline in the approval process for plan B. Yesterday was the last day of the highly unusual 60-day comment period that was asked for by FDA. Senator Clinton and I joined with nearly 10,000 Americans in calling on the FDA to take a real step toward closing the agency's credibility gap by making a prompt decision based on scientific evidence.

I am on the floor tonight to say I hope the FDA does just that. The language we secured in this conference report is a good step, but it 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 that I intend to use every tool available to me as a Senator to make sure this discussion about our priorities and our future is not lost.

I yield back my time.

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