Subject:   Court Ruling re: FDA Testing for Safety and Efficacy of Drug Use on Children
Date:   2003-04-04

In early October, a federal judge in US District Court in Washington ruled that the FDA cannot require research on children, when they are given drugs commonly given to adults. Such off label use is quite common – where individual doctors prescribe a drug for illnesses and populations other than was originally tested. The reasoning in the court decision is that statutory authority has not been explicitly provided by Congress – only those drugs and uses of drugs for which drug companies are seeking approval are actually required to be tested for safety and efficacy.

Three-fourths of medical drugs that are used by children have only been tested for adults. If a serious adverse event or a death occurs there is no mandatory reporting, so that doctors can benefit from the experience of others. Studies have suggested that thousands of deaths every year occur among adult medications that have been approved and are used within boundaries for which the drug was originally tested. To use drugs that have not been tested for safety or efficacy on children – an especially vulnerable population often more sensitive to drugs – raises serious concern.

Although CIRCARE supports testing on children, we only do so if significant and stringent protections are in place. These include:

1. an additional level of scrutiny for testing that carries greater than minimal risk;
2. exclusion of testing that is not for the direct medical benefit of the child, except under unique and compelling circumstances and after a public hearing.

Therefore we support legislation which both requires testing on children and places significant new protections in place.

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

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Last Updated: 2006-04-25

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