ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, October 8, 1996 TAG: 9610080085
SECTION: NATIONAL/INTERNATIONAL PAGE: A-3 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Los Angeles Times
The Clinton administration, already stung by Republican charges of complacency in the face of rising drug use, has come under a fresh round of fire for restricting the sale of home drug tests designed for parents to administer to their children.
While GOP presidential candidate Bob Dole has lodged most of the drug policy criticism so far, the latest salvoes are coming from Republican lawmakers who accuse the Food and Drug Administration of denying parents a potent weapon for fighting drug abuse in the home.
Led by House Commerce Committee Chairman Thomas Bliley, R-Va., the Republicans cite the FDA's actions as a prime example of what they characterize as a heavy-handed approach to regulating in an area where they believe parents' rights should be paramount.
At issue is whether ``Parents' Alert,'' a home drug test marketed by a one-woman company in Marietta, Ga., should be commercially available without undergoing a lengthy FDA approval process.
Priced at $40, the test kit consists of a urine collection cup, an envelope for mailing it to a government-approved laboratory, and a pamphlet explaining the meaning of the lab results, along with phone numbers of drug-abuse hot lines in the event of a positive result.
Since the mid-1980s, the FDA has treated home drug test kits as ``Class 3 Medical Devices.'' The designation puts Parents' Alert in the category of medical devices presenting the most serious risks if misused by the intended consumers
Other Class 3 devices include X-ray machines, cardiac pacemakers, extended-wear contact lenses and anti-snoring devices placed in the mouth during sleep.
In notes taken during a 1995 meeting with FDA attorneys, one company cited the agency's concern that such tests could cause ``family discord,'' and subject children to ``coercion'' from their parents.
LENGTH: Short : 44 linesby CNB