Court: FDA overstepping bounds

By Jon Dougherty

A U.S. district court has agreed with a physicians’ group that the Food and Drug Administration has been exceeding its authority over the regulation of pediatric drug trials.

The American Association of Physicians and Surgeons filed suit against the agency because it said the FDA overstepped its bounds when it began requiring trials of all new drugs on pediatric populations as a condition of approval.

Under the rule, “the FDA could require tests on children for off-label uses of drugs, even if they are intended only for adult use,” AAPS said in a statement. In its suit, the group argued that the “rule exceeds the FDA’s statutory authority and that the rule’s promulgation was arbitrary and capricious.”

If allowed to stand, AAPS said the rule would likely mean “further delays of life-saving medicines” being brought to consumers while “exposing children to unnecessary danger.”

The U.S. district court in Washington, D.C., agreed.

“If the rule truly gave the FDA the authority it claims, the door would be open to the FDA’s regulation of all off-label uses, based solely on the manufacturer’s knowledge that those uses are common-place,” said Judge Henry H. Kennedy Jr. in his 32-page opinion.

“The court finds that the Pediatric Rule exceeds the FDA’s statutory authority and is therefore invalid,” wrote Kennedy.

FDA claimed its authority under the provision, “Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients.”

A spokeswoman for the FDA told WorldNetDaily the agency currently is evaluating the ruling and has yet to decide whether it will appeal.

AAPS officials were pleased with the decision.

“Children are not guinea pigs in a regulatory grab for power,” said Dr. Jane Orient, executive director of AAPS. “It’s senseless for the FDA to require pediatric testing for drugs that expressly disclaim any use on children.”

Orient also accused the agency of power-mongering.

“There needs to be a housecleaning at the FDA before it seizes any more power for itself,” she said. “Hillary Clinton’s ‘for the children’ rationale for expanding government power has run out of steam.”

Joining AAPS in its suit were the Competitive Enterprise Institute, a nonprofit free-enterprise policy group, and Consumer Alert, a market economy advocacy organization.

“In our view, the Pediatric Rule constituted a drastic change in the drug approval process,” said Sam Kazman, CEI’s general counsel.

“While the rule was limited to pediatric uses, it opened the door for testing requirements for other off-label special patient populations and for other off-label uses,” he said. “The end result could be a far riskier and costly approval process, and ultimately, fewer drugs.”

“Using the Pediatric Rule, the FDA unilaterally seized authority to decide which drugs are to be labeled for pediatric use, and to order drug companies to conduct clinical trials on children to determine the drug’s proper use,” added Consumer Alert executive director Frances B. Smith. “This is a turn-around from accepted practice.”

On Monday the Bush administration said it was seeking changes to federal rules so companies could bring cheaper generic prescription drugs to market more quickly.

The Federal Trade Commission found earlier this year that big drug makers increasingly use delaying legal tactics to stifle competition and keep the cheaper alternatives out of consumers’ hands, sometimes for years.

Bush administration officials believe the change could save consumers $3 billion annually in drug costs.

The cost of generic alternatives averages about one-third the cost of brand-name drugs.

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