Doctors backing bill to require pediatric tests for drugs

A recent FDA decision to suspend the pediatric medicine testing rule has been reversed, but physicians still want the rule codified into law.

By Amy Snow Landa, AMNews staff. May 20, 2002.

Washington -- Pediatricians and others in the medical community were surprised when Food and Drug Administration officials announced in March plans to suspend a rule that requires new drugs to be tested for safe and effective use by children.

The American Academy of Pediatrics and other groups are strong supporters of the 4-year-old rule, which mandates that drugmakers conduct clinical trials on how their products affect children and include pediatric dosages on drug labels.

The FDA said it decided to set the rule aside for two years in light of a lawsuit that has been brought against the agency asserting that the FDA did not have the authority to issue the rule. Two conservative public interest groups and the Tucson, Ariz.-based American Assn. of Physicians and Surgeons filed suit in December 2000.

The pediatrician group reacted swiftly to news of the rule's suspension by joining with other child health advocates to try to pressure the Bush administration into reversing its decision.

The coalition wrote to Health and Human Services Secretary Tommy Thompson that it was "deeply distressed" by the FDA's decision to shelve the pediatric rule. Such a move would deal "a tremendous blow in efforts to provide appropriate medications for infants, children and adolescents," the group said.

AAP representatives also met with FDA Deputy Director Lester Crawford, DVM, PhD. They called the rule an important piece of the effort to address a shortage of information for doctors on how drugs affect children and at what doses they should be given. [...]