U.S. Backpedals on Drug-Testing Rule for Kids

Says it will force companies to conduct clinical trials

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By
HealthDay Reporter

FRIDAY, April 19, 2002 (HealthDayNews) -- The Bush administration reversed course today and announced that it would continue to force drug companies to conduct trials on how their medications affect children.

Health advocates called the reversal "a good day for kids."

Last month, the Food and Drug Administration said it would suspend its "pediatric rule" for two years. The FDA is fighting a lawsuit challenging the rule, and the agency wondered aloud whether it was needed at all in light of a bill President Bush signed into law earlier this year.

That move prompted immediate criticism from Democrats and children's health advocates, who accused the FDA of kowtowing to the drug industry.

But in a statement today, Secretary of Health and Human Services Tommy Thompson said, "Children need access to the same kinds of safe, effective treatments that are available to their parents, and that means conducting appropriateclinical trials."

The rule took effect in 1999, during the Clinton administration. It was drafted with the understanding that, when it comes to drugs, children are not merely miniature adults.

Adjusting doses in some drugs based on a person's size isn't always a success; sometimes the adjusted doses were either so low they were ineffective or so high they were dangerous.

The regulation says that, before they can win approval of a drug, pharmaceutical companies must first conduct clinical trials to test the drug's safety and effectiveness in children. It also gave the FDA authority to force companies to test drugs that were already on the market.

Three groups -- the Competitive Enterprise Institute, Consumer Alert and the Association of American Physicians and Surgeons -- sued the FDA over the regulation, arguing that such an intrusive and unnecessary action by the government would cost money and slow drug approvals.

"It's a good day for kids," said Dr. Richard Gorman, chairman of the drug committee for the American Academy of Pediatrics. "We're happy with this change of heart. We were surprised with the first change of heart."

Debate over whether the rule was necessary was prompted by the passage this year of the Best Pharmaceuticals for Children Act, which aims at the same goal through voluntary measures.

Under the law, drug companies extend the patents on their drugs for an additional six months if they agree to test them on kids. It serves as the carrot to the pediatric rule's stick.

Children's rights advocates argue that the pediatric rule is stronger because it "puts children at the table when drugs are being developed," Gorman said.

The gray area comes in when it involves drugs that were developed with adults in mind. Once approved, the medication can be prescribed by a doctor for anything or anyone.

Sam Kazman, an attorney for the Competitive Enterprise Institute, said the FDA was now caving in to pressure from the other side, but added that he suspected the agency never wanted to suspend the rule in the first place. The lawsuit will continue, he said.

The rule will be costly and keep some very helpful drugs from the market, he added.

"Someone's drowning and you want to throw them a life rope, and some agency says, 'Let me see the paperwork on that life rope,'" he said.

He also said it would be extremely difficult to find parents willing to subject their kids -- especially very young ones -- to clinical trials.

"The FDA is taking the place of a doctor about decisions about drug usage," said Frances Smith, executive director of Consumer Alert, another plaintiff.

But Gorman says the rule won't prevent any new drug from being approved for adults. The FDA can invoke the rule only if there is a "perceived" use for children, he said.

Jeff Trewhitt, a spokesman for the Pharmaecutical Researchers and Manufacturers Association, a drug industry group, said the group doesn't oppose the rule the way it is now written. That, along with the voluntary incentives, is an "honorable quid pro quo," he said.

What To Do

Talk to a doctor before giving a drug to your child; it may not necessarily behave the same way it does in a grownup.

For more on pediatric medicine, try the Food and Drug Administration or the American Academy of Pediatrics. To get the other side of the picture, try Consumer Alert.

SOURCES: Richard Gorman, M.D., chairman, committee on drugs, American Academy of Pediatrics, Ellicott City, Md.; Sam Kazman, attorney, Competitive Enterprise Institute, Washington, D.C.; Jeff Trewhitt, spokesman, Pharmaceutical Researchers and Manufacturers Association, Washington, D.C.; Frances Smith, executive director, Consumer Alert, Washington, D.C.; Health and Human Services press release

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