[Weekly Compilation of Presidential Documents Volume 33, Number 33 (Monday, August 18, 1997)]
[Pages 1241-1242]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
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 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

[[Page 1242]]

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 Elizabeth Glaser, founder, Pediatric AIDS Foundation; and 
Regan Ralph, whose son, Sam, was treated for asthma with drugs not 
labeled specifically for children.