Wall Street Journal - Monday, 7 July 1997.
Elyse Tanouye; Wall Street Journal Staff Writer

The company received two warning letters this year raising concerns about various aspects of the test, called Confide HIV. The home test to detect the presence of the virus that causes AIDS was approved in May 1996 and involved several steps: after purchasing the test for about $40 in a store or $49 from a toll-free telephone number, the customer was required to prick a finger, put a blood sample on the kit's filter paper and then send the filter paper to a special laboratory for analysis. The patient was then instructed to call for results seven days after mailing the test; for faster results, the company began providing envelopes from package-delivery service Federal Express Corp. with the tests in December.

The company initially sent the Federal Express envelopes to retailers and asked them to provide the envelopes to Confide test customers. In a March 31 warning letter, the FDA complained that retailers were sometimes attaching the envelopes to a competitor's product instead of Confide, resulting in users being unable to get results. A Johnson & Johnson spokesman said that the company soon began to shrink-wrap the envelopes with the kit, eliminating the problem.

On May 28, the FDA sent another warning letter raising concerns about the way J&J conducted a quality-control test of the filter paper before packaging it in the kit for sale. To test the paper's absorbency, the company was using frozen and thawed blood samples. But the FDA warned the company that the guidelines mandate the use of fresh, whole blood in the absorbency tests.

The company spokesman noted that the CDC used the frozen and thawed blood technique, and that the company had used the same technique in its clinical trials, which the FDA had reviewed and approved. "We didn't see any difference," said the spokesman, but the company agreed to switch to fresh, whole blood in its quality control tests.

The May letter also warned the company that it wasn't following regulations in reporting the test's false results and demographic information collected from test users. The company spokesman said J&J immediately made changes to comply with the FDA's demands.

The spokesman said the letters were "absolutely not" a factor in the company's decision to discontinue the tests. The company had completed all but one of the changes requested by the FDA and was in the process of making the changes to comply with the last one. Low demand was the reason the company dropped the test, the company said. Only 90,000 tests had been processed during the previous year and company officials didn't anticipate demand would grow, he noted.

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