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West Virginia Law Review

Document Type

Article

Abstract

Can the federal government insist that people use contraceptives? It may come as a surprise to learn that the U.S. Food and Drug Administration (FDA) has done just that as a condition for allowing access to some pharmaceutical products that create a serious risk of birth defects. Over the last few decades, the agency has demanded that patients using certain teratogenic agents—now numbering over a dozen drugs prescribed for a variety of conditions, ranging from severe acne and psoriasis to multiple myeloma and pulmonary hypertension—agree to avoid becoming pregnant, sometimes for years after completing their course of treatment. Undoubtedly the FDA should require that the manufacturers of such therapeutic products disclose their dangers as well as offer recommendations for ways of guarding against the risk of birth defects. When the agency purports to dictate the measures that patients must take in order to avoid becoming pregnant, however, it raises constitutional questions that somewhat surprisingly have failed to attract serious attention.

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