E-DRUG: U.S. FDA acts to make drugs safer for children
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The Food and Drug Administration has announced final regulations to
provide health care practitioners with specific information on the safe
and appropriate use of new drugs and biologics in children. The
regulations require that new drugs and biologics that are
therapeutically important for children, or will be commonly used in
children, have labeling information on safe pediatric use.
This announcement marks an important milestone in the administration's
effort to make drugs safer and more effective for children.
"Our children are the nation's most precious resource and we must do
everything possible to ensure they get the best medical treatment," said
President Clinton. "Today's action represents our continuing commitment
toward this goal."
Every year more than half of newly approved drugs and biologics that are
likely to be used in children lack information to permit safe and
effective use. Without adequate information, physicians may be reluctant
to prescribe certain drugs for their pediatric patients, or they may
prescribe them inappropriately. The new rule makes it more likely that
children will receive improved treatment because doctors will have more
complete information on how drugs affect children and what age-
appropriate doses are needed.
"Pediatricians and other health care providers will now have more
specific dosing information based on scientific evidence," said First
Lady Hillary Rodham Clinton. "This will make prescribing medication for
children safer and may also lessen the number of side effects."
The rule also allows FDA to require pediatric testing of
already-marketed products in certain compelling circumstances such as
when a drug is commonly prescribed for use in children, but the absence
of adequate labeling could pose significant risks.
FDA issued a regulation in 1994 simplifying the type of information
needed to demonstrate the safety and effectiveness of drugs in children
to encourage drug manufacturers to submit pediatric data voluntarily for
review. While these voluntary efforts were helpful, there are still a
large number of drugs and products without adequate pediatric labeling.
"We are committed to ensuring that health care providers get the best
information they need to treat children," said Michael A. Friedman,
M.D., Acting FDA Commissioner. "By simplifying the information
requirements, providing financial incentives in the FDA Modernization
Act and enacting these new regulations, we have taken great strides
forward."
The final rule allows pediatric data to be submitted after a drug has
already been approved if FDA has safety concerns about testing the drug
on children prior to testing it on adults. FDA, however, will not delay
the approval of a drug for adults if the pediatric studies are not yet
completed.
Even if the drug is one that is commonly used in children or will be
therapeutically important for children, the pediatric study requirement
can be waived entirely if:
�FDA finds that the product is likely to be unsafe or ineffective in
pediatric patients, �pediatric studies are impossible or highly
impractical, or �reasonable efforts to develop a pediatric formulation
have failed.
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