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Kathryn Serkes
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October 18, 2002
For Immediate Release:

FDA Overstepped Authority

Washington, D.C. - The FDA exceeded its authority by requiring trials of all new drugs on pediatric populations as a condition of approval, according to a ruling issued late yesterday by the United States District Court in the Washington, D.C.


The lawsuit, AAPS et al v. FDA, was brought by the Association of American Physicians and Surgeons , the Competitive Enterprise Institute and Consumer Alert.

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 and the other plaintiffs argued that the �Rule exceeds the FDA�s statutory authority and that the Rule�s promulgation was arbitrary and capricious.� The court agreed, writing, ��the court finds that the Pediatric Rule exceeds the FDA�s statutory authority, and is therefore invalid.�

Further, physicians and consumer groups filing the lawsuit believe the result would be further delays of life-saving medicines, and exposing children to unnecessary danger.


�If [the rule] truly gave the FDA the authority that 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. This authority would surely conflict with Congress�s will, and would eviscerate the long-established foundation of food and drug law, which allows, not the FDA�but the manufacturer of the article�to determine the use to which the article is to be put.� [Pg. 24]

�Congress adopted an incentive scheme while the FDA adopted a command and control approach. The two schemes differ in almost every possible regard�Far from complementing Congress�s voluntary incentive scheme, the Pediatric Rule usurps it by superimposing an often-incompatible regime.� [Pgs. 29-30]


The following statement was issued by Jane M. Orient, MD:

�Children are not guineas pigs in a regulatory grab for power. It's senseless for the FDA to require pediatric testing for drugs that expressly disclaim any use on children. We are gratified that the court agreed with us. We don't want the government requiring drug companies and doctors to expose children to unnecessary risks. Would you volunteer your child for experimental trials?

�No tears will be shed for curtailing the FDA�s power to delay new drugs. The FDA has withheld innovative drugs from needy patients for too long, and interferes with new treatments for terminal illnesses. Doctors, not the FDA, should be recommending prescription drugs for patients.

�There needs to be a housecleaning at the FDA before it seizes any more power for itself. Hillary Clinton's �for the children� rationale for expanding government power has run out of steam. We're thrilled that a court has limited the FDA's power to delay new drugs, and children will ultimately benefit.�

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