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Pediatric Drug
Testing Struck Down by Court
from
www.HealthinSchools.org
For more articles on disabilities and special ed visit
www.bridges4kids.org.
An effort by the federal Food and
Drug Administration (FDA) to require
drug manufacturers to conduct tests
on children to determine if new drugs
will be
safe and effective for pediatric use was struck down by
a federal court
October 17. In a challenge to the "pediatric rule" by
the Association of American
Physicians and Surgeons, Inc., the
U.S. District Court for the District
of Columbia said Congress didn't authorize the FDA to
set a pediatric requirement
when it passed the Food, Drug and Cosmetic Act
years ago.
The court pointed out that
because of the difficulty in finding
substantial pediatric populations to
undergo tests, along with the
ethical complications
associated with testing new drugs on children, many
drugs are tested for
safety and effectiveness in adults only. "As a result,
even though there are
many diseases that are common
to both children and adults, physicians
with pediatric patients often
find their treatment options
limited," with doctors
forced to choose between prescribing drugs without
well-founded dosage and
safety information or
utilizing other, possibly less effective, therapy.
Most often, doctors respond by prescribing
adult-approved drugs to
children, but in smaller doses.
In an effort to encourage
pediatric testing, Congress in 1997 passed the
Food and Drug Administration
Modernization Act (FDAMA), which
established an
experimental program giving manufacturers an extra five
years of market exclusivity
on drugs that they agreed to test in children.
But the incentive for voluntary tests
didn't increase pediatric testing
as much as the FDA had hoped,
so in 1998 the agency issued a rule requiring
manufacturers to submit pediatric tests for new
products that are likely to
be used by children, beginning in
December 2000. The regulation would
also allow the FDA to require
tests of already marketed drugs that it
suspects are risky for
children.
With that "pediatric rule" now
barred by the federal district court,
it's unclear what will happen
next in pediatric drug testing. The
FDA could take
its case to appeals courts and possibly even to the
Supreme Court, or
Congress could amend the Food, Drug and Cosmetic Act to
give the FDA specific authority to
require pediatric testing. Meanwhile, the
incentive for voluntary
pediatric testing by drug companies in return
for market protection remains
in place under the Best Pharmaceuticals for Children
Act, Public Law 107-119,
passed by Congress earlier this year.
The case decided October 16 was Association of American
Physicians and
Surgeons, Inc., v. United States Food and Drug
Administration.
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