The U.S. Food and Drug Administration has imposed increasingly restrictive conditions on access to pharmaceutical products such as isotretinoin (Accutance) and thalidomide that carry a serious risk of birth defects. This Article focuses on the requirement that female patients agree to use two forms of contraception, drawing parallels to suggestions that similar conditions apply to certain persons on welfare or probation, and posing hypothetical variations of the FDA's access restriction. If anyone ever challenged this aspect of the agency's risk management strategy, a court would have to decide whether the policy (1) grew out of state action (complicated by the fact that the FDA did not technically mandate it and could not sanction patients who failed to comply); (2) affected the exercise of a fundamental right (e.g., procreative liberty (declining contraception), free exercise/speech); (3) inappropriately conditioned access to a benefit on the waiver of one of these rights; and (4) failed strict scrutiny (in light of the argument made in other contexts that, even though the government may seek to minimize the risk of in utero exposure to teratogens, it lacks a compelling interest in preventing the birth of a child so exposed).
Too High a Price for Some Drugs?: The FDA Burdens Reproductive Choice,
San Diego L. Rev.
Available at: https://digital.sandiego.edu/sdlr/vol44/iss2/3