- The Washington Times - Saturday, April 20, 2002

The Food and Drug Administration is backing off its suspension of a rule requiring drug companies to perform safety testing of adult medicines commonly given to children.
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 measures render the old mandate hated by drug makers unnecessary. So it announced a two-year suspension of the "pediatric rule."
The action raised a storm of debate. Members of Congress complained the FDA was injuring children's health and this week announced plans for legislation that would have forced the agency to reinstate the mandate.
Yesterday, the FDA did so.
However, that does not mean the rule won't be tweaked. Also yesterday, the FDA began soliciting public comment on whether the rule overlaps too much with the financial incentives and new federal funding for child drug research or whether these measures still leave gaps that need to be plugged. The FDA will accept those comments through July.
But "we did not want to leave children unprotected" while the debate continues, said 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, Ohio Republican; Christopher J. Dodd, Connecticut Democrat; and Hillary Rodham Clinton, New York Democrat; said they would try to make the pediatric rule a law in the event FDA officials change their minds again.
"As we've seen before, what can be done can just as easily be undone," Mr. Dodd said. "Our children's health is simply too important not to have every tool and backstop in place to help with drug testing."
Adult medications are commonly given to children without safety or dosage tests because doctors have no alternative.
The FDA's pediatric rule was adopted in 1998. Among other provisions, it gave the body authority to order that adult drugs most used for children undergo proper testing.
Shortly after that, Congress passed financial incentives for companies to perform such testing, so it's not clear how often FDA had to force the issue. The financial incentives were reauthorized in January.
But lawmakers complained that pharmaceutical companies used the financial incentives to focus their studies on more expensive drugs, such as Prozac, instead of cheaper ones that no longer have patent protection but are used more widely among children.
A conservative think tank also filed a lawsuit against the FDA challenging the pediatric rule. The think tank was represented by an attorney recently appointed as the FDA's chief counsel; he reportedly has recused himself from the issue.
The FDA had announced the suspension of the pediatric rule in court papers involved in that suit. Yesterday, the FDA said it would continue to defend the rule's legal authority.

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