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.