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Date: Tuesday, January 21, 1997 FOR IMMEDIATE RELEASE Contact: Food and Drug Administration, Sharon Snider:(301)443-3285 Broadcast Media:(301) 827-3434,Consumer Hotline: (800) 532-4440
The product is marketed as Dr. Brown's Home Drug Testing System, made by Personal Health and Hygiene Inc., of Silver Spring, Md. It will be available in drug stores, pharmacies and other places where other over-the-counter products are sold.
"The Clinton Administration has zero tolerance for illicit drugs," said HHS Secretary Donna E. Shalala. "It is crucial for parents to talk openly with their children about the dangers of drug abuse. Parents also need access to the best medical information and drug-abuse counseling services. The approval of this test gives parents another option to consider to help ensure that their children remain drug-free."
The product consists of three components: a kit for urine collection, storage and mailing; a laboratory testing service; and a results and referral service.
The collection kit contains a paper cup for collecting urine and two plastic tubes with screw-on lids into which the urine is poured for storage and shipping. The tubes are placed in a plastic pouch which is inserted into a bubble bag for mailin g to a designated laboratory. Each kit has an identification number which is placed on the urine specimen, making it possible to obtain results anonymously. Directions for use and for obtaining and interpreting results are included in the kit.
The designated laboratory is certified by the Substance Abuse and Mental Health Services Administration, the College of American Pathologists, and Health Care Financing Administration. The lab evaluates the urine sample for possible tampering and then analyzes it for drugs of abuse. Screening tests used are those cleared by FDA. The lab then does confirmation testing to minimize false positive reports and sends the results via computer to the company's results center. Results are available one to three days after the lab receives the sample.
"Consumers have a right to expect accurate and reliable information from products like these," said FDA Commissioner David A. Kessler.
To obtain results, users call an 800 phone number and identify themselves by the identification number attached to the urine sample and instruction booklet. The user is informed of the results by a "Personal Health and Hygiene" phone re presentative, and given information about the meaning of the test result, the potential for false positive and false negative results. If necessary (or upon request) the caller is offered referrals for drug abuse counseling and medical assistance. The c enter operates seven days a week during designated hours.
A positive result indicates that the drugs tested for were present in sufficient quantity in the urine to be detected. FDA and the manufacturer recommend that test users who receive a positive test result, have questions about their results, or b elieve their results are inaccurate consult a physician for further evaluation. Although standard laboratory testing is highly accurate in detecting drugs of abuse in urine, certain medicines and, in rare cases, certain food may produce false positive t est results. In rare cases, it is also possible that technical or procedural errors in the lab or other factors could interfere with test results.
A negative result means that either the substances tested for are not present or that there is insufficient quantity to be detected. The time elapsed since drug use or exposure is a factor that may cause a false negative test result.
FDA's approval of the product was based on a number of factors. These included a review of scientific issues involved in the test system; sample stability; collection tube adequacy; effectiveness of labeling along with availability of the health representatives for conveying meaning of test results and limits of the procedure; and laboratory credentials and procedures which would ensure accurate and reliable test results.
Requirements for the marketing of home test systems for drugs of abuse are under review by the FDA and an interim policy is in effect for such tests. Under this interim policy, home tests for drugs of abuse may be marketed without FDA clearance i f three criteria are met: the laboratory conducting the testing uses FDA-cleared tests; the laboratory is certified by the Substance Abuse and Mental Health Services Administration; and the product has accurate labeling.
The manufacturer of Dr. Brown's Home Drug Testing System chose to pursue FDA approval through a Premarket Approval application (PMA), although the interim policy does not require a PMA.