HHS NEWS

P97-4                           Food and Drug Administration
FOR IMMEDIATE RELEASE           Sharon Snider:  (301) 443-3285
January 21, 1997                
                                Consumer Hotline: (800) 532-4440
         FDA APPROVES OTC TEST SYSTEM FOR DRUGS OF ABUSE
     The Food and Drug Administration today approved the first non-
prescription test system for drugs of abuse.  The test detects the
presence in urine of marijuana, PCP, amphetamines, cocaine, heroin,
codeine and morphine.
     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 mailing 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 representative,
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 center 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
believe 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 test
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 if 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.
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