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FDA Will Defend Pediatric Drug Rule in Court

FDA Will Defend Pediatric Drug Rule in Court

WASHINGTON—The Bush Administration has abandoned plans to suspend the Food
and Drug Administration’s "pediatric rule," which requires
pharmaceutical companies to study the use of drugs in pediatric patients when
seeking new drug applications.

One month after the agency revealed its plans in court papers, Health and
Human Services (HHS) Secretary Tommy G. Thompson pledged that FDA would
continue to enforce the rule. Moreover, he announced a new federal initiative
to ensure the safety and efficacy of drugs used to treat children and

"We will enforce and improve the FDA’s pediatric rule as we
simultaneously take additional steps made possible when President Bush signed
new legislation to promote the development of pediatric drugs," Mr.
Thompson said.

The pediatric rule, which became effective in April 1999, requires that
companies assess the safety and efficacy of drugs and biologics in pediatric
patients when seeking approval of a new active ingredient, indication, dosage
form, dosing regimen, or route of administration. It also gave FDA the
authority to require drug makers to develop a pediatric formulation to study in
a particular pediatric group, if necessary.

However, the Association of American Physicians and Surgeons and two
free-market advocacy groups—the Competitive Enterprise Institute and Consumer
Alert—challenged the legality of the rule in a lawsuit filed in federal
district court in 2000. The groups contend that FDA does not have the legal
authority to impose or enforce the pediatric rule.

Strong Negative Reaction

In court papers filed in March, FDA said it would suspend the pediatric rule
for up to 2 years as it evaluated whether the Best Pharmaceuticals for Children
Act (BPCA), signed into law by President Bush on January 4, made the pediatric
rule unnecessary.


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