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August 26, 1983

Alpha-fetoprotein in perspective

JAMA. 1983;250(8):1009-1010. doi:10.1001/jama.1983.03340080005002

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In June 1983, the Food and Drug Administration withdrew its proposed rule to restrict the sale, distribution, and use of α-fetoprotein (α-fp) test kits for the detection in utero of neural tube defects. The AMA applauds this action.

The maternal serum α-fp test can be the first of several steps in diagnosing a fetal neural tube defect. α-Fetoprotein testing has been available in this country for several years, but more extensive testing is anticipated upon introduction of the test "kits" approved by the FDA. While medicine awaits the introduction of the new α-fp test kits, it would be worthwhile to revisit the controversy that surrounds them. It is also worthwhile to reassess medicine's responsibilities in allaying public and policymakers' fears of innovative diagnostic and therapeutic technology.

In the 1980 preamble to the proposed rule to restrict use of α-fp test kits, the FDA acknowledged that "published results [1977 and 1979]