Article: WHy won't a simple drug test pass muster? (excerpts from testimony before the House Commerce Committee, Sept. 1996 on a home drug screening kit)(Transcript)

The following excerpts from testimony before the House Commerce Committee this past September frame the controversy over a decision by the Food and Drug Administration (FDA) to classify a simple home drug test kit as a Class III medical device on a par with CAT scanners, pacemakers, and X-ray machines. As part of this ruling, the agency demanded that the kit be removed from the market until it passes the FDA's lengthy approval process. Penalties for failing to comply include felony conviction, prison time, and civil fines of $15,000 for each kit sold.

Sunny L. Cloud, an insurance salesman, who developed the Parent's Alert kit and who tells her story here, ...

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