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.
Press Contact
Laura Capps/ Melissa Wagoner (202) 224-2633
Posted: March 2007
