    [Public Papers of the Presidents of the United States: William J. Clinton (1996, Book I)]
    [March 29, 1996]
    [Pages 523-524]
    [From the U.S. Government Publishing Office www.gpo.gov]

    Remarks on the Anticancer Initiative
    March 29, 1996

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

    [[Page 524]]

    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 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 cancer survivor Stacy Oller, who
    introduced the President. The Cancer Control Month proclamation is
    listed in Appendix D at the end of this volume.