WASHINGTON — The Food and Drug Administration is backing off its controversial suspension of a rule requiring drug companies to perform safety testing of adult medicines children commonly get.
The FDA last month said that because Congress recently passed financial incentives for drug makers to conduct those studies, it wanted to see whether the new law makes the old mandate--which drug makers hated--unnecessary. So it announced a two-year suspension of the so-called pediatric rule.
The action caused a storm of controversy. Members of Congress complained that the FDA was injuring children's health and this week announced plans for legislation that would have forced the agency to put the mandate back in place.
Also Friday, the FDA began soliciting public comment through July on whether the rule overlaps too much with the financial incentives and new federal funding of child drug research--or if all the measures leave gaps that still need filling.
But "we did not want to leave children unprotected" while that debate goes on, said the FDA's Dr. Murray Lumpkin.
Also, Bush administration officials announced that the National Institutes of Health would provide $7 million for similar pediatric drug research this year.
Lawmakers welcomed the FDA's reversal. But Sens. Mike DeWine (R-Ohio), Christopher J. Dodd (D-Conn.) and Hillary Rodham Clinton (D-N.Y.) said they still would try to make the pediatric rule law--in case FDA officials change their mind again.
Adult medications are given to children without studies of their safety or proper dosing because doctors have no alternative.
The FDA's pediatric rule was adopted in 1998.