Federal court overturns FDA ‘Pediatric Rule’

November 2002

WASHINGTON, D.C. — An FDA spokesperson said the agency is “weighing their options” on an appeal after a federal court ruled the agency did not have the authority to enforce the “Pediatric Rule,” which required drug companies to test adult medicines in the pediatric setting.

“We’re very disappointed that the courts have decided to overturn this rule that we’ve been enforcing throughout the case, and we’re currently reviewing the courts’ opinion and will weigh our options,” said Susan Cruzan, a FDA spokeswoman.

The ruling, issued by the U.S. District Court in Washington, stated that Congress never intended to give the FDA the power to enforce the rule.

Adult medications commonly are prescribed for children without studies, because studies in children are difficult to conduct. Small sample sizes make conducting the tests difficult, and consequently, a rarity. In 1998, the FDA issued the Pediatric Rule, allowing the agency to require tests for medicines that are commonly given to children.

A court challenge

The Competitive Enterprise Institute (CEI), the Association of American Physicians & Surgeons, and Consumer Alert filed suit against the rule in December 2000, saying the rule overlapped too much with the “Best Pharmaceuticals for Children Act,” which was recently passed by Congress and takes a financial incentive-based approach to encourage off-label pediatric testing.

The court agreed that the FDA could not force drug makers to conduct tests of children if they are not seeking a pediatric indication.

“The pediatric rule may well be a better policy tool than the one enacted by Congress; it might reflect the most thoughtful, reasoned, balanced solution to a vexing public health problem. The issue here is not the rule’s wisdom,” the court wrote in its opinion. “Indeed, if that were the issue, this court would be a poor arbiter indeed. The issue is the rule’s statutory authority, and it is this that the court finds lacking.”

In March, the FDA suspended enforcement of the rule, saying it wanted to see if the new law worked on its own, but the agency again began enforcing the rule under pressure from Congress and several physician organizations, like the AAP.

AAP official reacts

“This court decision returns children to the status of a therapeutic afterthought by the pharmaceutical industry. While adults will be ensured that drugs on the market are safe and effective for their use, children will not be afforded the same assurances,” said Louis Z. Cooper, MD, AAP president, in a statement.

Cooper said that the Best Pharmaceuticals act serves as a “complement” to the Pediatric Rule, but that the two have different roles. The AAP points out that the rule gives the FDA the authority to refuse to approve new drug applications if manufacturers refuse to conduct pediatric studies, while the act does not.

“With this decision, the status of the rule is uncertain and appeals take time. That’s why we are calling on Congress to act immediately and pass legislation this year to codify the Pediatric Rule,” Cooper said. “If the court believes the FDA overstepped its jurisdiction, then Congress can give the power to the agency by enacting this legislation now.” The bill to codify the rule has unanimously passed at the committee level of the Senate, and has been introduced in the House of Representatives.

But CEI’s general counsel, Sam Kazman, said in a statement, “the FDA essentially claimed it could force new uses, or new patient populations — in this case, children — on a label,” Kazman said.

Kazman said it would increase the cost of drug testing.

For Your Information:

• Read the court’s ruling at http://ww.cei.org/pdf/3254.pdf.