Henley v. Food and Drug Administration
United States Court of Appeals for the Second Circuit
77 F.3d 616 (1996)
- Written by Mary Phelan D'Isa, JD
Facts
In 1989, the Food and Drug Administration (FDA) revised its requirements for patient packet inserts for oral contraceptives. Before 1989, the FDA required a specifically worded warning that estrogen, a component of oral contraceptives, has “been shown to cause cancer in animals, which showing justifies the inference that estrogens may cause cancer in humans.” After 1989, the specific animal carcinogen warning was no longer required. Elizabeth Henley (plaintiff), on behalf of a women’s health organization, filed a citizen petition with the FDA, requesting it to amend the warning label requirements for oral contraceptives to include a warning about women limiting their exposure to animal or human carcinogens. Citing post-1989 scientific studies involving women and oral contraceptives that indicated no increased risk of cancer in humans, the FDA denied Henley’s petition. The FDA explained that it continually monitors scientific information relevant to the use of oral contraceptives and accordingly updates its labeling guidance to drug companies. Henley appealed.
Rule of Law
Issue
Holding and Reasoning (McLaughlin, J.)
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