Mr. Chairman and Members of the Subcommittee, I am Bruce Burlington, Director of the Center
for Devices and Radiological Health, Food and Drug Administration (FDA or the Agency), and I
am here today to discuss FDA's regulation of over-the-counter (OTC) test systems for drugs of
abuse. Specifically, I will address FDA's proposed rule on the regulation of these products
and the Agency's interim policy, issued on October 3, 1996, which has provided for the
availability of test collection systems sold directly to parents for use in the home while FDA
develops the final rule. I also will address our working relationship with the Substance Abuse
and Mental Health Services Administration (SAMHSA) and the status of drug testing
In November 1996 and February 1997, this Subcommittee held hearings on the Agency's
regulation of drugs of abuse test systems. The Agency listened to the concerns you and others
expressed regarding the regulation of drugs of abuse test systems. We reevaluated our policy and
developed a common sense proposal that encompasses a level of regulation that takes into
account the public health concerns associated with these test systems, but also imposes the
minimal level of regulation necessary to address those concerns. As outlined below, the
approach we proposed will be minimally disruptive for two reasons. First, it eliminates the
premarket approval or clearance requirements for drugs of abuse test systems that
satisfy minimal criteria. Second, it provides for a long transition period to allow companies time
to conform to the policy.
Drugs of abuse test sample collection systems typically consist of a collection cup or other
container for collecting a specimen, directions for use, packaging for storage or mailing, access
to a laboratory testing service using an appropriate test, and access to test results and counseling. The consumer collects a specimen (such as urine) from the body and mails it to a laboratory,
which performs the actual testing for the drugs or metabolites. The specimen usually is
identified by a code number, which maintains confidentiality and protects against mix-ups. The
test results are communicated back to the consumer.
The Federal Food, Drug, and Cosmetic (FDC) Act regulates these products as in vitro diagnostic
medical devices. As such, they are subject to various controls designed to protect
consumers by assuring the products are of high quality, labeled accurately and with adequate
instructions for use, and independently evaluated to ensure that they achieve their
FDA's Relationship with SAMHSA
The U.S. Department of Health and Human Services supports accurate and reliable drugs of abuse
testing. SAMHSA certifies laboratories engaged in employee drug testing for Federal agencies,
identifies the tests that can be used, and trains physicians on the interpretation of drug testing
results. Recognizing that the usefulness of testing for drugs of abuse resides in its accuracy
and reliability, the National Institute on Drug Abuse (NIDA) sponsors a national program of
research on basic methodology and clinical applicability of drug testing methods. NIDA has
supported research to advance and refine its knowledge of the scientific basis and application of
drugs of abuse testing. These projects encompass studies of the science of hair, saliva,
and sweat testing and directly address scientific questions related to sensitivity, specificity,
reproducibility, and reliability of the test methods, their relative strengths and weaknesses, and
their applications -- the type of data that can form a basis for informed regulatory and approval
FDA and SAMSHA have a long history of interacting on drug testing issues, on an informal
basis, to ensure scientific consistency between the two agencies. In general, when relevant topics
are to be presented at the agencies' respective advisory or panel meetings, the agencies request
representation, as appropriate.
Scientific information is freely shared between the two agencies, with appropriate controls to
protect proprietary information.
SAMHSA's drug testing program for Federal workers specifically requires the use of products
cleared or approved by FDA. FDA encourages manufacturers to state in their applications
whether and how their products meets cut-off levels established by SAMHSA for use in
The Interim Policy
On October 3, 1996, FDA established an interim policy in which we agreed not to take
regulatory action against persons distributing home drugs of abuse test sample collection systems
so long as: (1) the laboratory conducting the testing used an FDA-cleared test, (2) the testing
laboratory met SAMHSA's or equivalent standards for performing such testing, and (3) the
product had accurate labeling.
It is important to note that this interim policy covers only home test sample collection systems
for drugs of abuse that are intended to be sold directly to parents for use in the home and
that are to be processed by a laboratory. Point-of-care tests which provide immediate results are
not covered by this policy.
III. FDA'S PROPOSED POLICY
FDA believes that three basic criteria are needed to assure that drugs of abuse test sample
collection systems are safe and reliable for use in a nonprofessional setting. First, the
laboratory test(s) must have been recognized by FDA as accurate and reliable. This will ensure
that drugs of abuse test systems that are sold to consumers will be based on accurate and reliable
laboratory testing. Since FDA already has cleared more than 200 laboratory urine tests to detect
drugs of abuse, companies would have a relatively easy route to marketing OTC drugs of abuse
urine test systems. Once this new policy is implemented, however, companies seeking to market
a system that uses a hair test or any other test that has not been recognized by FDA would
need to establish the validity of the test with FDA prior to marketing. FDA's proposed policy
implementation would allow ample time for companies to do this.
The second criterion for ensuring that drugs of abuse test sample collection systems are safe and
reliable for use in a nonprofessional setting is that the laboratory performing the underlying
test(s) must be able to perform reliably the necessary initial and confirmatory tests. This will
ensure that testing is performed by individuals with appropriate levels of training, knowledge,
and proficiency; that confirmatory testing is systematically performed on presumptively positive
samples prior to issuance of the test results; and that assistance with interpretation of the test
results and follow-up counseling is available to the consumer by a trained health professional, if
There are approximately 75 laboratories certified by SAMHSA that would meet the requirements
set forth in the second criterion and thousands of laboratories certified under the Clinical
Laboratories Improvement Act, many of which would have the appropriate types of controls.
The third criterion to ensure that drugs of abuse test systems are safe and reliable for use in a
nonprofessional setting is that samples are adequately identified to avoid mix-ups and that
the system is accurately labeled so that consumers can readily use it.
On the basis of these criteria, on March 5, 1998, FDA published in the Federal Register a rule
that would reclassify OTC test sample collection systems for drugs of abuse testing from
class III (premarket approval) into class I (general controls), and to exempt them from the
premarket notification (510(k)) and current good manufacturing practice requirements. The
proposal also designates these systems as "restricted" devices under the FDC Act. The
restrictions are to ensure that: (1) the underlying laboratory tests are accurate and reliable, (2) the
laboratory performing the tests has adequate expertise and competency, and (3) the product has
adequate labeling and effective methods of communicating test results to consumers.
Under FDA's proposal, FDA would consistently regulate: (a) home drugs of abuse test sample
collection systems and (b) drugs of abuse test sample collection systems that are used in the
insurance, workplace, and sports settings. If the tests currently being marketed are reliable, the
impact on testing provided in these latter venues is expected to be small for two reasons. First,
FDA is proposing that the products be exempt from the premarket approval or clearance
requirements of sections 515 and 510(k) (provided the conditions/criteria for assuring
their accuracy and reliability are met); and, second, if a manufacturer/distributor wants to market
a test sample collection system for use in the insurance, workplace, or sports setting that does not
rely on use of a laboratory test that has been recognized by FDA, the transition period prior to the
effective date of the final rule will provide sufficient time to obtain FDA recognition for any test
that is accurate and reliable.
Until our policy is finalized, however, the Agency is not actively regulating drugs of abuse test
sample collection systems used in the workplace, insurance, or sports settings. Because
the Agency has not been actively regulating test sample collection systems used in these settings,
we provided for notice and comment prior to changing its practice.
The Agency requested written comments on the proposed rule by July 6, 1998. In addition, the
Agency held a public hearing on the proposal on June 19, 1998. Seven speakers asked to address
the proposal. Two opposed it, four supported it, and one elected to submit written comments.
The two speakers opposing the proposal recommended that FDA review the devices and labeling
prior to marketing and, therefore, objected to the 510(k) exemption provision. They were not
opposed to OTC availability for the tests.
Alternative Technologies for Drug Abuse Testing
FDA has cleared over 200 products for drugs of abuse testing for use in both clinical laboratories
and physician office laboratory testing. The vast majority of these are for testing in urine.
Approximately ten tests utilizing sweat, saliva, and meconium (in infants) have been cleared by
FDA. When evaluating tests for use in different settings, the data requirements, as well as our
expectations with respect to performance, may differ. In other words, we recognize we may need
to make tradeoffs in product performance for enhanced access to information the tests can
Hair testing holds the potential to evaluate drug use over past weeks to months, instead of hours
or days. Hair testing also may not be as subject to corruption as urine tests, and not as
personally offensive. Many scientific questions remain, however, about the effectiveness of hair
testing for detecting drug use, including: identifying which drug(s) can be detected in hair,
how much drug use is required to establish a detectable level in hair, how long a drug or its
metabolites remains in the hair, how to account for environmental exposure to drugs, and how to
control for these factors. In addition, we know that dark hair, curly hair, blond hair, and dyed
hair react differently, thus creating questions of equity among ethnic groups and genders.
FDA has no preconceived opinion on the effectiveness of this technology. The Agency has not
been presented with adequate independent data on the effectiveness of such tests. FDA would
consider hair a novel matrix (non-liquid, with the requirement for unusual extraction and with a
variety of new questions relating to potential interference from internal and external
factors). Premarket approval will be required, most likely, for any submission for a drugs of
abuse test utilizing hair or hair extracts. The basic questions to be asked in reviewing tests
utilizing hair samples would be the same as for any drugs of abuse testing device and would
relate to the types of analytes being tested for (native or metabolite), the analytical
sensitivity and specificity of the test, the diagnostic use of the device, the clinical relevance of
chosen cut-off levels, and appropriate labeling.
As a consumer protection agency, FDA's most important role in overseeing the regulation of
diagnostic tests is to assure that they provide the right answers. Due to the absence of trained
medical professionals, this consideration is especially critical for drugs of abuse test systems sold
directly to consumers, whether those consumers are parents, employers, or coaches. FDA
believes that its proposed regulatory approach would accomplish this goal because it focuses on
the accuracy and reliability of the underlying test(s). At the same time, FDA's proposal would
significantly ease the requirements that must be met in order to sell these products. Moreover,
because it would provide an adequate transition period, there should be no interruption of
the availability of test systems for use in nonprofessional settings.
I am pleased to answer any questions. Thank you.