FDA Approves Home Drug Test Kit

By Lauran Neergaard

Associated Press - January 1997

WASHINGTON - An over-the-counter test that lets parents check their children for drug use won Food and Drug Administration approval Tuesday, the first in the controversial field to do so.

Dr. Brown's Home Drug Testing System can detect cocaine, heroin, marijuana, PCP, amphetamines and other drugs in a mail-in urine sample.

The approval comes four months after the Clinton administration battled congressional charges that, in the face of escalating teen-age drug use, the FDA was blocking parents' efforts to test their children.

"The approval of this test gives parents another option to consider to help ensure that their children remain drug-free," said Health and Human Services Secretary Donna Shalala.

But use of the test is not restricted to parents, leaving it open for anyone to use. Test creator J. Theodore Brown Jr., a Silver Spring, Md., psychologist, expects it to be widely used by relatives of people fresh out of drug treatment, who are ripe for relapse without the deterrent of daily testing.

"It's therapeutic, nonpunitive and comparatively inexpensive," Brown said. "This system would be something to empower the individual citizen."

Last September, critics attacked the FDA for cracking down on an Atlanta woman who sold 1,000 home drug test kits without the agency's knowledge. The FDA said it had no way to know if her test was accurate, but congressional critics argued the agency merely was keeping from parents the same test employers can use - and charges that it has no clear policy to say when home tests for any disease are ready for laymen.

The FDA relented, letting home drug tests be sold temporarily while it re-evaluates how strictly such kits should be regulated.

Before the fray erupted, Brown in January 1996 asked the FDA to approve his home drug test. On Tuesday the FDA wrote Brown that his kit was the first to win government approval, giving him a marketing advantage over unapproved competitors sold during the agency's temporary amnesty.

"Although parents can breathe a sigh of relief today, the FDA has neglected to lay out a strategy for approving any other home testing kits," said critic Rep. Richard Burr, R-N.C., who called on the FDA Tuesday to settle the issue for the growing hometesting industry.