Requiring a physician's prescription for hormonal emergency contraceptive pills makes no sense. Unintended pregnancies remain endemic in the United States, and wider use of emergency contraceptive pills could substantially help. However, the prescription requirement poses an unnecessary barrier to prompt, effective use of this preventive therapy. According to the Durham-Humphrey Amendment of 1951, the default option for all new drugs is, in principle, over-the-counter, unless a drug is addictive or dangerous when self-administered. Clearly, hormonal emergency contraception is neither of these. Emergency contraceptive pills meet all the customary criteria for over-the-counter use: low toxicity, no potential for overdose or addiction, no teratogenicity, no need for medical screening, self-identification of the need, uniform dosage, and no important drug interactions. The Food and Drug Administration is authorized, and, by its own regulations, should be required to switch hormonal emergency contraception to over-the-counter status without delay. The current prescription requirement is not only gratuitous but also harmful to women's health because it impedes access to this important therapy.
Both the public health need and Food and Drug Administration regulations mandate a switch of hormonal emergency contraception from prescription-only to over-the-counter status.
Family Health International, Research Triangle Park, North Carolina; and The Center for Reproductive Law and Policy, New York, New York
Address reprint requests to: David A. Grimes, MD, Family Health International, PO Box 13950, Research Triangle Park, NC 27709; E-mail: email@example.com
Received January 9, 2001. Received in revised form March 19, 2001. Accepted March 23, 2001.