WASHINGTON — As the
latest initiative in his crusade to improve health care for
children, President Clinton on Wednesday ordered
pharmaceutical companies to test most new drugs for safety
and proper doses for children.
action that I take today simply is designed to ensure that
parents and pediatricians have the safety information they
need," Clinton said.
The proposed Food
and Drug Administration regulation potentially will affect
millions of children, but likely will be felt most by those
who suffer from such ailments as AIDS, depression and
evidence that drugs affect children differently than adults,
more than half of the drugs commonly prescribed to children
have not been tested on children and lack special dosage
information for them, according to the FDA.
Officials say that
pediatric testing poses a problem because parents are usually
unwilling to give permission to allow their children to
Under the proposed
regulation, which will take effect after a 90-day period for
public comments, manufacturers of prescription drugs likely to
be used by children will be required to conduct studies on
them and put information on drug labels.
The FDA estimates the
regulation will cost drug companies $20 million per year. The
FDA estimates that about 12 new drugs per year will need to be
studied for the effects on children. Drug companies have
expressed lukewarm support of the initiative.
"In view of all the
ongoing testing and studying of medicines in children, we
question whether a government mandate is needed," said Alan
Holmer, president of Pharmaceutical Research and Manufacturers
of America, which represents the leading companies in the
industry. "However, we are committed to working with the
president and others in the administration on a collaborative
and constructive basis regarding their proposed regulation to
advance the goal of better medicine for children."
Some drugs already on
the market, which often are prescribed for children but lack
dosage information for them, also would have to be tested for
children under the proposed regulation. Decisions on which of
the existing drugs must be tested will be made on a
case-by-case basis, said William Schultz, deputy FDA
The FDA compiled a
list of the 10 drugs most widely prescribed for children but
not tested for them. All told, these drugs were prescribed 5
million times in one year for children in age groups for which
the labels carried a disclaimer or lacked adequate information
* Alupent for
treatment of asthma, which was prescribed 184,000 times to
patients younger than 6.
* Ritalin for
treatment of attention deficit disorder, prescribed 226,000
times to children under 6.
injections for treatment of infection, prescribed 639,000
times to patients younger than 12.
* Auralgan otic
solution for treatment of ear pain, prescribed 600,000 times
to patients under 16.
* Prozac for
treatment of depression, prescribed 349,000 times to patients
co-founder of the Santa Monica-based Pediatric AIDS
Foundation, a not-for-profit organization dedicated to
research for children with HIV, said most Americans do not
realize that doctors are prescribing medicine to children
without adequate studies to test safety and dosages for them.
"The public does not
understand that this is a problem to begin with," said
DeLaurentis, whose organization has pushed hard to get the FDA
to require pharmaceutical companies to test for children.
Since only half of
the HIV drugs for adults have been approved for
children--including only two of the four available protease
inhibitors--children with HIV are missing opportunities to
extend and improve their lives, she said.
"Any child who is
not afforded a lifesaving treatment is going to suffer for
it," DeLaurentis said.
DeLaurentis' best friend and co-founder of the organization,
and Glaser's daughter, Ariel, both died of AIDS. According
to DeLaurentis, the mother's health improved rapidly when
she started taking AZT. But when she asked the doctor to
give the drug to her daughter, whose health was declining
rapidly, the doctor said it was impossible because it was
not yet clear what dosages of the toxic medicine were
appropriate for children.
When Ariel, who was
7 at the time, started taking AZT in 1988, she was able
within weeks to talk, walk and play for the first time in
months. But her immune system was so weak that she died
later that year. Her mother lived until 1994.
"I believe that if
Ariel had gotten [AZT] earlier, it could have had a
remarkable impact on her life," said DeLaurentis.
During the White
House ceremony, First Lady Hillary Rodham Clinton, who knew
the Glasers, said she recalled the "heartbreaking problem"
Elizabeth Glaser faced when she learned that her daughter
could not take the drug that was so dramatically improving
her own health.
"Too many medical
treatments that are saving adult lives are slow in finding
their way to children," Mrs. Clinton said.
The new FDA
regulations will change this, she added.
"The plan the
president is announcing today will see to it that no child
or parent will have to endure this kind of agonizing
uncertainty," she added.
industry reacted to the news of the mandatory regulations by
stressing that it had already responded to the
administration's 1994 call that it undertake the effort
Holmer said a 1997
survey found 146 new medicines in development for children,
including 36 for cancer and nine for AIDS. All 146 had been
tested for pediatric use.