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46 Hastings L.J. 403 (1994-1995)
HIV Home Testing and the FDA: The Case for Regulatory Restraint

handle is hein.journals/hastlj46 and id is 445 raw text is: HIV Home Testing and the FDA: The
Case for Regulatory Restraint
In the late 1980s the FDA adopted a de facto blanket ban on
human immuno-deficiency virus (HIV) home-testing kits.1 Under the
ban, the agency has declined, as a matter of policy,2 to approve
premarketing applications for HIV home-testing products.3 The ban
gained public attention in the 1990s, as a number of companies ap-
plied for FDA premarketing approval of HIV home-testing kits de-
spite the agency's unequivocal position.4 In 1994 an FDA advisory
panel5 (1994 Panel) held hearings to reassess the agency's position on
IV diagnostics.6 The 1994 Panel was established in response to man-
* Associate Professor, Graduate School of Business, University of Texas at Austin.
B.A. Hofstra University; M.A. Dartmouth College; J.D. The College of William and Mary;
M.A., Ph.D. The Wharton School of the University of Pennsylvania.
1. For the sake of brevity, I shall occasionally use the phrase home testing as short-
hand for home testing for HIV. I shall refer to the kits for home testing of HIV as home-
testing kits.
2. See infra note 17. Despite its clear and consistent position against HIV home-
testing products through early 1994, FDA spokespersons have occasionally suggested that
no categorical FDA position exists in regard to the products. See, ag., Rebecca Kolberg,
FDA Urges Caution on Home AIDS Tests, UPI, Mar. 23, 1989, available in LEXIS, Nexis
Library, WIRES File (citing such testimony by then-FDA Commissioner Frank Young).
3. Home-testing products have been approved for marketing and are currently mar-
keted for numerous other purposes, including the provision of information regarding preg-
nancy, blood pressure, asthma, urinary disorders, diabetes, and cholesterol. For a brief
discussion of the nature and function of several of these products, see Jane B. Clark, Home
Test Kits: Welcome to the Modem Medicine Cabinet, KIPLINGER'S PERS. FIN. MAG., Nov.
1992, at 112.
4. See infra note 18 and accompanying text.
5. FDA advisory panels are the first level at which premarketing applications for
medical devices are scrutinized. See Federal Food, Drug, and Cosmetic Act (FDCA)
§515 (c)(2), 21 U.S.C. §360e(c)(2) (1983 & Supp. V 1993).
6. A technical distinction is sometimes made between blood collection test kits
and home test kits. When this distinction is made, blood collection kits refer to kits that
require the user to send the blood they collect to a laboratory for analysis; home test kits
refer to kits that permit the user to take the sample and to perform the test at home. See


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