Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
The Associated Press - Tue, 13 Dec 94
"The FDA now for seven years has sat on a proposal for home-access HIV testing and counseling," said Paul Weyrich, president of the conservative Free Congress Foundation and a founder of National Empowerment Television.
"We are not going to tolerate this unconscionable delay any longer, and if they persist we will seek a legislative remedy, which I think is now very possible given the new political realities in Washington," Weyrich said at a news conference.
William Mellor III, president of the conservative Institute for Justice, said his organization is exploring legal options to force the FDA to speed up its process.
"In this case, delay means death," Mellor said.
The issue of home testing has proved quite controversial. Proponents contend hundreds of thousands of Americans who currently refuse to be tested at public health clinics would take advantage of a test they could buy at a drug store and use in the privacy of their home. After pricking a finger, consumers would send the dried blood spots to a lab and get the results by telephone.
Experts in the field believe at least 40 percent of the estimated 1 million infected Americans have never been tested.
Critics question whether the telephone counseling offered with the home kit service would be adequate to inform about health risks and guard against suicide. They also are worried that the test could be misused by employers and that the testing could provide inaccurate results.
Opponents also have criticized Johnson & Johnson, which is the furthest along in the approval process. AIDS activists have contended that the company is illegally promoting its home test kit in advance of FDA approval. Johnson & Johnson has denied running illegal promotions.
FDA spokesman Don McLearn said he couldn't discuss whether agency approval of the home test kit is imminent. But he dismissed complaints by Weyrich and others that the agency's process is dragging on without justification.
"There is a sense of urgency, but FDA has to be sure that any product fulfills the requirements of the law that it be safe and effective for use and has to be labeled correctly and has to be able to be used properly," he said.
Copyright (c) 1994 - The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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Copyright © 1994 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
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