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The Food and Drug Administration (FDA) today issued a revised draft guidance for manufacturers of drug abuse screening tests that updates two previous draft guidances published in 2000. This new guidance supersedes the previous documents and clarifies current FDA thinking for both laboratory and non-laboratory (workplace, sports, insurance, and home) tests.
“FDA intends to be clear about the regulatory requirements for drug abuse screening tests, and we intend to enforce these requirements fully, so that the public can be confident that drug abuse screening tests will be used both effectively and fairly,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D.
“The tests available today can benefit the safety and well being of children in school, consumers buying products, and adults on their jobs. But they also should not be misused, because they can have important consequences for school records, professional opportunities, and insurance costs. With this guidance, the agency is seeking to get the benefits that the tests can provide to the public without avoidable costs of misuse or unnecessary regulation. And we will be vigilant to make sure that happens,” he said.
The agency is also taking steps toward more effective enforcement in the marketing of drugs of abuse testing products. In addition to issuing the proposed guidance, FDA today sent letters to four companies that market sample collection kits for drugs of abuse testing, advising them that the tests used on collected samples have not been cleared, approved or otherwise recognized as accurate and reliable by FDA. The firms each sell systems intended to test hair samples for drugs of abuse. The draft guidance is intended to help these companies, and others seeking to prepare pre-market submissions for drugs of abuse tests, comply with FDA regulations.
Tests covered by the guidance include screening tests for amphetamines, cocaine, methamphetamines, opiates, cannabinoids (marijuana), and phencyclidine (PCP). Premarket review by FDA is required for these tests.
The guidance continues to describe the types of studies recommended by FDA
to establish reliability, and also the types of information that the agency
recommends be included on the label. However, it describes new and more
flexible options for companies preparing marketing submissions for these tests.
In particular, previous recommendations that the cost of confirmatory testing
be bundled with the cost of screening tests have been replaced by recommendations
for cautionary labeling and other controls to address concerns over possible
inaccurate preliminary results.
Previous recommendations that performance testing for non-laboratory use be conducted with untrained lay users have been replaced by a wider menu of performance testing options. The revised guidance recommends performance testing using laboratory professionals, health care professionals, trained lay users, or untrained lay users, depending on the setting in which the tests are expected to be used. As a result, labeling for these devices may be designed to better match the broad array of testing personnel and arrangements used in non-laboratory settings. This increased flexibility should lower costs and increase access, while maintaining test quality.
FDA recommends that because of the potential for both false positive and false negative results from all such tests used in any setting, the label recommend that positive results be confirmed using a different test method.
FDA also recommends that the label explain that the tests are not always accurate. A positive test result does not always mean a person took illegal drugs, and a negative result does not always mean a person did not take illegal drugs. A variety of factors can influence the reliability of drug tests, and the agency suggests that manufacturers list substances known to interfere with the tests. Clear and correct labeling is likely to improve test use and meet a major FDA goal of promoting consumerism.
For home use tests, FDA also recommends that firms conduct home use consumer studies to see if untrained users are able to follow the instructions, obtain acceptable test results, correctly interpret them, and understand the limitations of the test results.
The guidance does not apply to tests done in the law enforcement setting. FDA defers oversight of forensics use to the existing system of legal controls.
A copy of the guidance, “Draft Guidance for Industry and FDA Staff: Pre-market Submission and Labeling Recommendations for Drugs of Abuse Screening Tests,” is available at http://www.fda.gov/ohrms/dockets/98FR/2003d-0522-gdl0001.doc.
The public has 90 days to comment on the draft. When finalized, the guidance will represent the FDA’s current thinking on this topic.
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