    [Public Papers of the Presidents of the United States: William J. Clinton (1997, Book II)]
    [August 13, 1997]
    [Pages 1098-1099]
    [From the U.S. Government Publishing Office www.gpo.gov]

    Remarks Announcing Action on the Safe and Effective Use of Medications
    To Treat Children
    August 13, 1997

        You know, one of the most important rules about being President is
    to never go on after the star of the show. [Laughter] I would like to
    thank all of you for being here today. The Vice President, the First
    Lady, and Secretary Shalala have spoken about what we're trying to do
    and acknowledged the work of many individuals and groups. But I want to
    thank Dr. David Kessler, who as the Vice President said, used to work at
    the FDA; Dr. Friedman, the Acting Commissioner of the FDA. I also want
    to thank Dr. Koop, who wrote us a letter in support yesterday. And
    Hillary mentioned our good friend Elizabeth Glaser. I got a wonderful
    letter today from her husband, Paul, about how much this would mean to
    their son, Jake. And so, all of you who have been in this situation, I
    thank you for helping this day come to pass. And I thank Regan Ralph for
    her eloquent speech under some duress. [Laughter] I thank her spouse for
    doing what I think is a noble duty there. [Laughter] And next time we'll
    let you give the speech, and the rest of us will handle Sam. [Laughter]
        I'm glad Sam came up here today and showed us what childhood should
    be like. It's what kids that are 1\1/2\ year old should be doing, and
    they should be able to do it. They should be able to do it. And
    according to the American Academy of Pediatrics, more than 50 percent of
    the medicines that have proved helpful for children have not been
    adequately tested for children's use. That is not acceptable.
        The executive action that I take today simply is designed to ensure
    that parents and pediatricians have the safety information they need.
    Doctors have known for a long time that children respond differently
    than adults to many drugs. In cases--many cases, children can only
    tolerate vastly scaled-down doses. In some cases, their bodies simply
    haven't developed enough to take any dosage of a medicine that has been
    perfectly safe for adults.
        Moreover, we still don't even have good information about medication
    for some of the most common childhood illnesses that Hillary mentioned,
    like asthma, allergic reactions, ear infections. And we certainly don't
    know enough about medications for treating life-threatening diseases.
    Less than half the drugs used to help the estimated 12,000 children with
    HIV infection in our country have been tested for use

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    in children. Information is especially sparse for children under 2, the
    time when the medication may be most needed.
        Without clear guidance, pediatricians sometimes decide not to
    prescribe for children drugs used successfully by adults, and this means
    that the children may well be being deprived of what may be the very
    best treatment available. And as the Vice President said, the
    pediatrician's other alternative is to guess, with potentially grave
    consequences. Some time ago, for example, doctors gave infants small
    doses of a crucial antibiotic commonly used by adults, but it turned out
    that the infants were unable to clear the drug from their bodies and
    large amounts built up in their livers, and because of needed dosage
    studies which had not been done, 23 infants died.
        The rule I announce today will put an end to this guesswork. It will
    require manufacturers of all medicines needed by children to study the
    drugs' effects on children. The results will then be displayed on drug
    labels to help pediatricians and other health care professionals make
    good decisions about how to treat their young patients. Groups
    representing patients, physicians, nurses, pharmacists, and drug
    manufacturers all have indicated their willingness to help us implement
    this new rule, and we appreciate their willingness to do so.
        I also want to applaud Senators Dodd and DeWine and Congressman
    Greenwood and Congressman Waxman, all of whom have introduced
    legislation that would provide additional incentives for drug
    manufacturers to perform the needed dosage studies in children. Their
    approach is compatible with the rule we're announcing today, and I look
    forward to working with them on this issue as Congress continues our
    bipartisan efforts to pass comprehensive FDA reform this fall.
        And I know Congressman Greenwood and his children are here; I'd like
    to ask him to stand. Thank you, sir, for being here. We appreciate your
    work. In your new position in the Congress, you may have many more
    controversial issues to deal with but few that will do more good. And we
    thank you for your leadership.
        Today we take one more significant step toward assuring quality
    health care for our children, building on our historic commitment in the
    balanced budget to extend health care coverage to 5 million of them who
    don't have it today.
        Again let me say, when something like this happens the President
    gets to give a speech, but the credit goes to all the people who worked
    on it, to all the parents, to those who kept working for this even after
    their children suffered terrible injury and sometimes even death, to all
    the members of the professional groups. You deserve the credit. And I am
    very grateful to you for bringing this matter to my attention and giving
    me the power to use what the law has given me as President to do what
    you know and to do what you have long known is the right thing to do.
    This is your day.
        As the First Lady has often said, children are not rugged
    individuals; they depend upon us to give them love and guidance,
    discipline, and the benefit of good medical care. Today their dependence
    has been justified. Their future and ours depends upon how well we
    continue to do this important work.
        Thank you very much.

    Note: The President spoke at 2:19 p.m. in Room 450 of the Old Executive
    Office Building. In his remarks, he referred to Paul Michael Glaser,
    widower of Pediatric AIDS Foundation founder Elizabeth Glaser; and Regan
    Ralph, whose son, Sam, was treated for asthma with drugs not labeled
    specifically for children.