FDA gives approval to home drug tests

By Marliene Cimons

Los Angeles Times - Jan 1997

WASHINGTON - The Food and Drug Administration on Tuesday approved the first over-the-counter home test kit designed for parents to determine whether their children are using drugs.

The product can detect in urine the presence of marijuana, PCP, amphetamines, cocaine, heroin, codeine and morphine. It will be sold in drug stores and other outlets.

The decision came several months after congressional Republicans harshly criticized the FDA for what they called its infringement of parental rights by refusing to sanction a home kit being marketed by a Georgia woman.

The woman, Sunny Cloud, has sold the kit by mail order from her home, and has refused to seek FDA licensing through regular channels.

The kit approved Tuesday by the FDA, however, is not the same one touted by GOP lawmakers last fall.

The new product, which will be marketed as Dr. Brown's Home Drug Testing System, was developed by Personal Health and Hygiene Inc., a Silver Spring, Md., company that chose to undergo the agency's review process.

The FDA regards home test kits as medical devices under its jurisdiction. In the past, the agency had expressed serous concerns about how parents, acting without the aid of a physician and untrained in drug counseling, would interpret and react to results. Those reservations were overcome in the Dr. Brown's test.

Rep. Thomas J. Bliley Jr., R-Va., chairman of the House Commerce Committee, who had championed Cloud's cause, on Tuesday again criticized the FDA's handling of the issue, saying "there is considerable doubt over whether the FDA has jurisdiction over these kits in the first place."

He said he has asked the oversight and investigations subcommittee to conduct more hearings on the FDA's handling of test kits.

Cloud, reached in Marietta, Ga., said she knew nothing about the new product but she praised the agency's action.

"It shows that the FDA is concerned about the drug problem and is willing to look for ways to help parents fight it," she said.

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