FDA Orders Drug Makers to Specify Children’s Dosage

The children’s dosage for drugs frequently used in pediatric cases would have to be spelled out on the label under regulations put into place Friday by the Food and Drug Administration.

Every year, more than half of the newly approved drugs that are likely to be used by children have insufficient information from the manufacturers about safe pediatric use, according to the FDA.

The rules, a Clinton administration initiative, are intended to make the manufacturers give doctors and other health care providers more complete information on pediatric use so they won’t be hesitant to prescribe needed drugs, the FDA said.

“We are committed to ensuring that health care providers get the best information they need to treat children,” said Dr. Michael A. Friedman, the agency’s acting commissioner.

The regulations fit into a regular pattern for the Clinton administration--modest initiatives that guarantee positive exposure on popular issues.

The classic example of the problem has been with AIDS drugs, many of which were approved without pediatric testing, FDA officials say. In some cases, companies went back and did testing to determine correct dosages for children only after the drugs were approved.

“These regulations mean that--finally--children can share in the research progress against disease,” said actor Paul Glaser, who lost his wife and daughter to AIDS and whose son is HIV-positive.

“Most of the time, children have been an afterthought in pharmaceutical research,” said Susan DeLaurentis, a co-founder of the Elizabeth Glaser Pediatric AIDS Foundation, named after Glaser’s late wife.

Pharmaceutical industry officials have said they already provide such information for many drugs, and have questioned whether a federal mandate is needed. The regulations will ensure that such labeling is done routinely on the drugs.

Officials with the Pharmaceutical Industry Manufacturer’s Assn. were not available Friday to comment on the regulations.