FDA Actions Anger House

October 7, 1996

FDA Actions Anger House

The FDA's refusal to grant marketing approval for a home drug- testing device is drawing fire from the House Commerce Committee. At a hearing late last week, the committee won a pledge from FDA officials that the agency will not take regulatory action against Sunny Cloud, a woman who has been marketing a home drug test without FDA approval. But the same day, the agency sent a letter to Cloud's lawyer reiterating its position that the test is a Class III device requiring extensive review for approval. During the hearing, committee members questioned the Class III designation when the agency does not regulate drug tests in the workplace.

Commerce Chairman Bliley and other committee members the next day denounced the agency's action, and FDA Commissioner David Kessler went to Capitol Hill for an impromptu meeting with the committee at which he gave written and oral assurances the agency would take no action against Cloud until it completes a review of its designation of home drug test kits as Class III devices. Bliley also demanded the agency give him a list of the people involved in the incident by Monday of this week, and said he would demand resignations at the agency. Bliley Tuesday said he has not received an adequate response.

FDA official Bruce Burlington told the committee at the hearing the agency gave the test a Class III designation because it requires home diagnostic tests to have the highest reliability ratings. FDA spokesman Jim O'Hara told CongressDaily that home tests for HIV, glucose and cholesterol all have Class III designations. However, during questioning, FDA officials raised issues of the potential of the device for creating family discord, and said workplace tests are not regulated because they are administered by professionals. Committee members accused the agency of showing paternalistic attitudes toward parents concerned about possible drug use by their children. Cloud's test requires a urine sample to be mailed to a drug testing laboratory for analysis by laboratory professionals.

The Christian Science Monitor Thursday quoted White House Drug Czar Barry McCaffrey as saying home drug testing is not a "magic bullet" for preventing teen drug use, but that parents should have the option of using the tests. FDA's O'Hara said the agency has no problem with the concept of home testing for drugs, but it wants to make sure consumers have accurate information and that the tests are adequately labelled for their intended use. In addition, some approved Class III home diagnostic tests require lab analysis and some give the consumer immediate results, O'Hara said. FDA's main objection to Cloud's device is that she has been marketing it without agency approval, he said. The "Aware" home drug test kit is available under prescription with FDA approval, but the agency has denied approval for over-the-counter sales.

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