Subject: Court Ruling re: FDA Testing for Safety and Efficacy of Drug Use on Children
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:
Therefore we support legislation which both requires testing on children and places significant new protections in place.
Michael A. Susko MS, CIRCARE President
Adil Shamoo Ph.D., CIRCARE Co-Founder
Link: To create an HTML link to this InfoMail cut and paste the following:
<a href="http://www.circare.org/im/im4Apr2003.htm">Court Ruling re: FDA Testing for Safety and Efficacy of Drug Use on Children</a>. CIRCARE InfoMail (2003-04-04)
Last Updated: 2006-04-25
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