[Weekly Compilation of Presidential Documents Volume 32, Number 13 (Monday, April 1, 1996)]
[Pages 587-589]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Remarks on the Anticancer Initiative

March 29, 1996

    Mr. Vice President, Secretary Shalala, Dr. Kessler, Congressman 
Richardson, welcome.

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To all of you who are here, I welcome you, and I thank you, each in your 
own way, for the power of your example.
    I thank Stacy, too, especially for being here and telling us her 
story and doing it in the way that she did. We know we can thank modern 
medicine, but you saw a little bit of her steel and grit when she was 
talking, and it's a great testimony to her faith and to her inner 
strength. I think that we ought to ask her parents to stand since she 
mentioned them.
    Would you stand up, please, Mr. and Mrs. Oller? Thank you. 
[Applause] Thank you very much.
    Perhaps more than any other health statistic in America, cancer 
touches virtually every family. My mother and my stepfather succumbed to 
cancer; the Vice President lost his sister. Just before coming here 
today I proclaimed April Cancer Control Month over in the Oval Office, 
and I was there with several cancer patients and their families. They're 
all over here, and I want to thank all of them for coming to visit with 
me, the children and the adults alike, the parents, the brothers, the 
sisters. As families, they are fighting for a way to win this battle, 
and the rest of us owe it to them to give them every chance they can to 
win. That's why we're here today; we want to have more people like 
Stacy.
    More than ever before, we know from the sheer statistics that cancer 
is treatable and beatable. We know that early detection and prevention 
are critical. We have, therefore, put more resources in to mammograms 
for women over 50, and we have taken a very strong stand against the use 
of tobacco by young people and against any attempt to induce them to use 
it.
    When cancer does strike, we have an ever-growing arsenal of new 
drugs and cutting-edge therapies to fight it. But before any treatment 
can get to patients, we need to make sure it is safe and effective. The 
development and approval process can take years. When a member of a 
family get cancer, the whole family bears the pain and years are 
sometimes far, far too long. These families should not also suffer from 
the stress of knowing that there may be better remedies already out 
there, but they're somehow not quite available.
    So I'm happy today to say to those patients and to their families, 
the waiting is over. Today, we announce a major new initiative to speed 
new cancer therapies to our people. These changes will affect at least 
100 drugs now being studied. Dozens of them will get to the market 
sooner, and that means they can help Americans suffering from cancers of 
the breast, lung, ovary, prostate, and colon, among others. For these 
Americans, we cannot guarantee miracles, but at least now new hope is on 
the way.
    With our reforms, cancer patients won't have to leave the country to 
look for promising treatments. If a drug does demonstrate effectiveness, 
patients will have access to it here even while the drug continues to 
undergo tests for approval. Let me emphasize, these steps will speed 
cancer drugs to patients who need them when they need them. They will 
help to save lives. They will give cancer patients a better chance. They 
will do all this by cutting redtape, but they will not--they will not--
cut corners on safety. We are doing this the right way, and it is the 
right thing to do.
    This initiative is part of our National Performance Review, 
popularly known as REGO, reinventing Government. This remarkable effort 
has been chaired brilliantly by the Vice President, and it will, among 
other things, now cut the development time for drugs by as much as 
several years. At the same time, the FDA will cut its review time for 
these drugs from 12 months to 6 months.
    The initiative contains four major proposals:
    First, we propose to accelerate approval for cancer drugs by 
allowing companies to apply to market a treatment that is still being 
tested. In other words, if a drug shows promise by shrinking tumors, for 
example, it can be considered for approval. That could cut several years 
off the time needed to get a drug to market.
    Second, we propose to expand access to drugs that are already 
approved in other countries. The FDA will encourage the sponsors of 
these experimental drugs to apply for permission to distribute the drug 
to eligible

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cancer patients before final drug approval is granted here in the United 
States.
    Third, we propose that cancer patients be better represented in FDA 
advisory meetings. These committees play a major role in policy and 
product decisions. And cancer patients who have valuable insights and 
the most at stake should be at the table when these decisions are made.
    Fourth, we propose fewer applications for additional uses of 
approved cancer drugs. Often, these applications are for uses the drug 
maker does not even intend to market. By cutting out these unnecessary 
applications, we will free investigators from paperwork and allow them 
to devote more time to cancer research.
    These four steps are the results of listening to patients, to their 
families, to their advocates, to the pharmaceutical industry, the 
doctors, and the researchers. This initiative shows what we can do when 
we work together.
    Since 1938, our Nation has looked to the FDA to protect and improve 
the public health by making sure that medicines we take help us, not 
harm us. Our commitment to safety must never waver. Under Commissioner 
David Kessler, the FDA has reinforced that commitment while working to 
speed drug approval in the right way. In 1987 it took an average of 33 
months to approve new drug applications. In 1994 96 percent of new drug 
applications were acted on within 12 months.
    On AIDS drugs the United States was the first to approve five of the 
six antiviral treatments for the disease. The most recent of these drugs 
was approved in 42 days, a record. And the FDA has been the first to 
approve new drugs for ovarian cancer, for lymphocytic leukemia, for 
cystic fibrosis, for multiple sclerosis, for Lou Gehrig's disease and 
Alzheimer's. Under Dr. Kessler, more than ever, the FDA is a place where 
advance science and common sense work together for the American people.
    Now using the principles of the National Performance Review, we have 
an opportunity to help more Americans conquer cancer. These four steps 
will make a big difference, and we are glad to give them to the American 
people today.
    Now I'd like to ask the Vice President to come up here and talk just 
a few moments about the reinventing of these regulations, how we did it, 
what we hope will happen. And let me say, again, how grateful I am to 
Secretary Shalala, to Dr. David Kessler, and to the Vice President, and 
to all the other good people at FDA. We can keep our people safe and 
save more lives, and that's exactly what we're determined to do.
    Thank you, God bless you all.

Note: The President spoke at 3:06 p.m. in the East Room at the White 
House. In his remarks, he referred to Stacy Oller, who introduced the 
President.