CBS News Correspondent Sharyl Attkisson reports the requirement, which ended decades of parental guesswork when it was adopted three years ago, is costing drug companies millions.
It also created new challenges, like finding young test subjects. Drug companies aren't eager to face cases like the one involving baby Gage Stevens, who died in a study of the heartburn drug Propulsid.
His mother Gretchen Stevens warns, "Don't ever put your child in a study even if they say it's gonna be monitored closely."
Competitive Enterprise Institute fought pediatric testing from the start, and even sued, claiming it hurts more than it helps.
"When FDA demands additional testing, even for as sensitive a population as children, it's adding additional hurdles to actually making those therapies available, which means it's denying patients access to new treatments," reasons Sam Kazman, CEI general counsel.
Dropping the requirement for pediatric studies means going back to letting doctors guess which drugs are safe for children and in what doses. Some in Congress are accusing the FDA of buckling under pressure from the drug industry, and are urging President Bush to intervene.
Rep. Henry Waxman, D-Calif. says, "They're throwing in the towel in order to benefit the drug manufacturers, but they're doing it at the expense of our kids."
The FDA's turnaround might mean the end of some, but not all, pediatric testing. Drug companies that voluntarily test children can get automatic extension of their patents, which is the biggest prize of all -- holding off a generic competitor can be worth hundreds of millions of dollars.