WASHINGTONThe 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 adolescents.
"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 groupsthe Competitive Enterprise Institute and Consumer Alertchallenged 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.
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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.