Delay That Could Prove Deadly : FDA should quit stalling on HIV self-test

The Food and Drug Administration has come under harsh attack from many Republicans and some Democrats in Congress who call it a sluggish federal agency that deprives Americans of worthwhile drugs and medical devices. We do not necessarily agree, for the agency has proved over the years to be a good shield against such tragedies as the horrible birth deformities that occurred in Europe a generation ago after an improperly tested pregnancy drug, thalidomide, was approved there.

But the FDA is only providing ammunition to its enemies by delaying its decision on an over-the-counter self-test for the virus that causes AIDS. After nearly eight years of litigation and debate, an FDA advisory committee last June recommended approval. Agency officials hinted strongly then that at least one such mail-in test would be approved by last September or October, pending resolution of difficult questions of how best to counsel those who prove positive for the deadly virus. In a memo dated Sept. 20, Dr. David A. Kessler, the agency’s commissioner, assured the White House chief of staff, Leon E. Panetta, that the FDA was working “expeditiously” on the application.

Yet there is still no word, even as more people become infected by HIV. The main opposition comes from the National Lesbian and Gay Health Assn., whose members operate clinics nationwide and argue that face-to-face counseling is better than the phone response envisioned by the test makers. These clinics have been great tools in the fight against AIDS, but concerns about future funding should not override the possibility of extending testing to millions who fear to enter a gay clinic or live in rural areas far from such services.

The gay community, chief victim of the AIDS scourge, had opposed testing on civil rights grounds. But the availability now of effective therapies, if not cures, for AIDS has substantially changed that view. It appears that most AIDS groups and doctors now support self-testing.

The main applicant to supply the home test is Direct Access Diagnostics, a subsidiary of Johnson & Johnson, the New Jersey-based pharmaceutical maker. The gay clinics recently charged that the company was engaging in unlawful promotion of the test by using the former surgeon general, Dr. C. Everett Koop, in television appearances. He is a consultant to the company, earning $10,000 a quarter.

FDA officials say that such considerations are not delaying approval; they attribute the delay to concerns about whether the company is properly equipped to manufacture the test and whether the test would hinder public health efforts to monitor the epidemic. Those are proper concerns. But the fact remains that fewer than half of those at risk for contracting the AIDS virus have been tested, and even most of those who test positive get little counseling. The FDA should act soon.