THE VIRGINIAN-PILOT
Copyright (c) 1997, Landmark Communications, Inc.
DATE: Wednesday, January 22, 1997 TAG: 9701220425
SECTION: FRONT PAGE: A2 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: 53 lines
An over-the-counter test that lets parents check their children for drug use won Food and Drug Administration approval Tuesday.
Dr. Brown's Home Drug Testing System can detect cocaine, heroin, marijuana, PCP 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.
Test creator J. Theodore Brown Jr., a Silver Spring, Md., psychologist, expects it to be used by relatives of people just out of drug treatment, who could relapse without the deterrent of testing.
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 that the agency was keeping from parents the same tests employers can use - and charged 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-evaluated 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 home-testing industry.
Brown said his kits will reach drugstores within six weeks and will cost less than $30.
Consumers will mail a urine sample in a tamper-proof package to a government-certified laboratory. The lab uses FDA-approved drug tests, doing confirmatory retesting to minimize false results. One to three days later, consumers call a toll-free number for the results.
Every drug test can miss abuse, when, for example, the urine is sampled too late. It also can falsely signal abuse if, say, the person were to eat certain foods that mimic the metabolites drug tests measure.
Brown's Personal Health and Hygiene Inc. will explain those limitations before giving callers their test results, and it will offer referrals for drug abuse counseling or medical care.
KEYWORDS: FDA HOME DRUG TEST