Since the late 1980s, the FDA has adopted a de facto ban on human immuno-deficiency (HIV) home-testing kits. This ban has remained FDA policy even though many individuals, including those in high risk groups, have still not been tested for HIV. While pressure from the new Congress may eventually result in a change in FDA policy toward HIV home testing, the FDA presently continues to resist that change.
Professor Salbu argues that the FDA should never have adopted a blanket ban on HIV home-testing kits. He maintains that the ban was the result of speculation of psychological problems that might accompany the results of HIV home testing. Rather than consider these secondary effects, Professor Salbu contends, the FDA should only consider the primary safety and effectiveness of HIV home-testing products in evaluating whether a home-testing product should be approved. Professor Salbu concludes that when analyzed on a case-bycase basis, the arguments for lifting the FDA ban on HIV home-testing kits vastly outweigh the arguments against such a change in policy.
Steven R. Salbu,
HIV Home Testing and the FDA: The Case for Regulatory Restraint,
46 Hastings L.J. 403
Available at: https://repository.uchastings.edu/hastings_law_journal/vol46/iss2/2