The FDA’s Recent About-Face: Plan B Age Restriction Is Unlawful Rulemaking and Violates Minors’ Due Process Rights
Volume 81, No. 1, Spring 2008
By Anna Pikovsky Krishtul

Nearly half of all fifteen- to nineteen-year-olds in the United States are sexually active. A sexually active teen who does not use contraception has a ninety percent chance of becoming pregnant within a year. Together, these statistics signal an alarming public health crisis: rising rates of unwanted teenage pregnancies in the United States.

Rather than fulfilling its congressional mandate to protect public health, Food and Drug Administration (“FDA”) decision making, fueled by a shifting political climate, has been aimed at appeasing social and political groups. In August 2006, following years of controversy, the FDA issued a decision approving Plan B as emergency contraception for over-the-counter use. It provided that Plan B should be used within seventy-two hours of intercourse if regular contraception failed or was not used. The FDA determined that Plan B is safe and effective, has only minor side effects, and will not terminate a pregnancy if a fertilized egg is already attached to the uterus. FN In short, Plan B is a backup method of contraception for use in emergency situations. Though the FDA’s decision is a step in the right direction, it falls short of a complete success. While the decision granted over-the-counter access to Plan B, it included an age restriction: those under eighteen must have a prescription for the drug.

In light of the Supreme Court’s recognition of a fundamental due process right to access contraception, the FDA’s decision should be overturned on two grounds. First, the decision constitutes unlawful rulemaking, and a federal court should overturn it under the Administrative Procedure Act (“APA”). Second, the age restriction is functionally equivalent to a parental notification law and must be found unconstitutional because it fails even a minimal rational basis review. In light of overwhelming scientific data, the age restriction should be removed and minors should have unrestricted access to Plan B.

Part II.A of this Comment provides general background about the FDA, how prescriptions drugs may be switched to over-the-counter status, and standards for judicial review of executive agencies. Part II.B then provides Plan B’s medical description as well as a detailed history of the FDA’s treatment of Plan B from 1997 through August 2006. Part II.C explains the FDA’s asserted rationale for the age restriction, provides a general description of parental notification laws, and, more specifically, discusses minors’ due process rights under the Constitution. It also includes a brief description of examples of federal and state attempts to legislate access to contraceptives for minors. Part III.A argues that the FDA’s decision constitutes unlawful rulemaking because it is arbitrary and capricious and, therefore, should be overturned. Part III.B then argues that the age restriction on access to Plan B is unconstitutional because it is a contraceptive, and minors have a due process right to access contraceptives. Finally, Part III.C concludes by analyzing the ramifications of the FDA’s decision and suggests eliminating the age restriction so that Plan B is widely available in the United States.

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