White House to suspend child drug-test rule

By Ceci Connolly, Washington Post, 3/19/2002

ASHINGTON - The Bush administration plans to suspend a federal requirement that drugmakers test their products to determine whether they are safe and effective for children.

Food and Drug Administration officials said yesterday that the regulation would be suspended for two years so the agency can determine whether it is still needed. The requirement may have become unnecessary because after it was imposed, Congress enacted six-month patent extensions for any company that voluntarily conducts clinical trials on children, officials said. The patent extensions, which in some cases generate hundreds of millions of dollars in additional revenue, have triggered a wave of new pediatric studies, they said.

The decision, revealed in a court filing, would set aside a 1997 Clinton administration regulation aimed at providing doctors and parents better information when giving children medications, which mostly have been tested only on adults.

''We remain deeply committed to ensuring that prescription drugs used in children are safe, and properly studied and labeled,'' Lester Crawford, the FDA's deputy commissioner, said in a prepared statement.

Because it is more difficult, costly, and potentially dangerous to test drugs on children, drug companies historically have primarily tested pharmaceuticals on adults. Doctors have often extrapolated from the results to determine whether the drugs would work in children and at what doses.

The decision was criticized by pediatricians and other medical experts who say that voluntary testing will once again leave doctors guessing about which medications are safe to give children.

''Unfortunately, there is not good information about what drugs to use, in what dose, and when to use them in children. Often, they are flying blind,'' former FDA commissioner David Kessler said of doctors. ''The FDA's action today is five steps backward. I don't understand how the agency could have done this.''

Robert Ward, a professor of pediatrics at the University of Utah and spokesman for the American Academy of Pediatrics, said that when he began practicing medicine, pediatricians made a guess about giving the hypertension drug Priscoline to infants. After 10 years of study, he and others determined that the doses they gave babies ''were enough to stop their hearts.''

Doctors will also be at a loss for information about drugs such as Ritalin, Ward said. Under the rule, the FDA could have requested studies of the controversial drug for children under 6, an age group that has not been monitored in any clinical trial.

Democratic lawmakers rushed to criticize the decision.

''It appears the FDA has put up the white flag of surrender, leaving children exposed to products that have not been tested for their use,'' said Senator Hillary Rodham Clinton, Democrat of New York. ''It amounts to an abdication of responsibility.''

Representative Henry Waxman, Democrat of California, said the incentives were only half the equation in getting better data about the impact of drugs on children. ''Before there was a rule, the companies didn't bother to do these studies,'' Waxman said.

Senator Edward M. Kennedy, Democrat of Massachusetts, said the decision ''makes no sense.''

This story ran on page A4 of the Boston Globe on 3/19/2002.
© Copyright 2002 Globe Newspaper Company.