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Statement of Senator Edward M. Kennedy Hearing on Drug Safety and User Fees

WASHINGTON, March 14, 2007-I welcome our committee members and our distinguished witnesses to today’s hearing on improving the drug user fee program and enhancing drug safety.  

Patients across the nation look with hope to our biotechnology and pharmaceutical research to develop medical breakthroughs for the illnesses they face.  Every day that such breakthroughs are delayed is another day of hope denied for patients afflicted with cancer, Parkinson’s disease, spinal cord injury, or other serious conditions.   
We in Congress have a responsibility to see that FDA has the expertise, the information and resources it needs to make the right decisions as quickly as possible for the patients who need such treatments. Obviously, the need for swift review does not mean that drugs should be rushed to market, regardless of proper safety precautions.  A review conducted with inadequate regard for safety subjects patients to unacceptable risks of serious side effects, or even death.
The user fee program that the committee considers today is an attempt to strike the right balance.  Its goal is to give FDA the support it needs to review new drugs as swiftly as proper regard for safety allows.  Most drugs are now approved first in the United States, due in part to the user fee program, which has reduced both review times and approval times for new drugs.  I commend FDA and the biotechnology and pharmaceutical industries for having reached agreement on recommendations to Congress for the renewal of this essential program. All of us are committed to moving the reauthorization through Congress as quickly as possible.
The user fee program, however, demonstrates the failure by Congress to give FDA the funds it needs to do the job that the American public counts on it to do.  Congress ought to correct this failing, so that FDA does not have to rely excessively on user fees for its basic budget.

Thorough reviews are essential in assuring drug safety, but the commitment to safety does not stop when the initial review is completed.  As the recent Institute of Medicine report emphasized, there must be a life cycle approach to drug safety—that includes both a thorough initial review and ongoing reviews to oversee safety throughout the life cycle of the drug.  Part of the ongoing responsibility for assuring safety is to take effective action to protect patients from unacceptable risks that are detected after drugs reach the market.
The approach described by the IOM is at the heart of the bipartisan legislation that Senator Enzi and I have introduced on drug safety.  Our legislation gives FDA clear authority to require label changes after drug approval, and to make certain that additional safety studies are conducted where needed.  Our proposal includes a structure to oversee safety that is flexible enough to be tailored to the unique characteristics of each new drug, and strong enough to protect patients from unacceptable risk.

The same goal of improving safety and protecting patients also underlies the legislation that our colleague, Senator Dodd, has introduced with Senator Grassley on the issue.  Senator Dodd was among the first to recognize that Congressional action is needed to improve drug safety, and I commend him for his vision and leadership in this important area.
Although there are significant differences in our two bills, their basic goal is identical—to see that consumers receive the best, most effective, and safest drugs possible.  Our bills also share the goal of giving patients and doctors access to the best possible information about risks and benefits when they choose among different drugs to treat a disease. I look forward to working with Senator Dodd, and all the members of the committee on these important issues.

It’s an honor to welcome all of our distinguished witnesses to today’s hearing, but it is a particular pleasure to welcome Dr. Andrew von Eschenbach for his first hearing in which the word  “Acting” has been removed from his title as Commissioner of FDA. The agency needs a strong, effective and confirmed leader, and I commend our colleagues, and particularly the skillful chairmanship of Senator Enzi, for enabling FDA once again to have a confirmed Commissioner at the helm.
We are also graced today by the presence of one of his illustrious predecessors as Commissioner, Dr. Mark McClellan.  I understand that he comes to us after attending a conference that IOM convened on this issue on Monday.
I also welcome, Ms. Kim Witczak, who will describe in personal terms the tragic loss that can occur when we fail to get it right on drug safety.
I also welcome Diane Dorman of the National Organization for Rare Disorders and Dr. Bruce Burlington of Wyeth Pharmaceuticals who will provide valuable perspective from the viewpoints of patients and the pharmaceutical industry on this important issue.

Your recommendations will help guide our committee and Congress as we take up the vital work of renewing the drug user fee program and giving FDA the resources and authority it needs to do the job that American families are counting on it to do.

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Posted: March 2007