2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC767
Submitter : Ms. Silvia Henriquez Date & Time: 05/17/2004 06:05:54
Organization : National Latina Institute for Reproductive Health
Other Organization
Category :
Issue Areas/Comments
The National Latina Institute for Reproductive Health (NLIRH) condemns the Food and Drug Administration?s refusal to change the status of Plan B emergency contraception from prescription-only to over-the-counter. We believe that by ignoring the recommendation of its own expert committees, the FDA is impeding access to this important contraceptive option.

Emergency contraception has been proven to be safe, reliable and a responsible means of preventing pregnancy. Emergency contraception does not cause abortion and will not affect an established pregnancy. It poses no serious health risks; there is no danger of overdose or potential for addiction, and the dosage is the same for all women. As its name suggests, emergency contraception (EC) is about responding to emergencies. Plan B can dramatically reduce a woman?s chance of becoming pregnant if taken within 120 hours of unprotected sex. It is most effective when taken within 24 hours after sex. Therefore, having to obtain a prescription for EC is a medically unnecessary barrier which often prevents women from accessing EC in time.

The availability of over-the-counter emergency contraception can play a dramatically important role in reducing unintended pregnancies, abortion and sterilization rates among Latinas, enabling Latinas to exercise greater reproductive choice. Additionally, it is likely to benefit an especially vulnerable population, namely, the disproportionately high numbers of young, low income and uninsured Latinas with limited access to family planning and reproductive health care services who may experience contraceptive failure or unprotected sexual intercourse. As such, we believe Latinas are a key constituency whose reproductive options could be greatly improved by the provision of over-the-counter emergency contraception. We are greatly disappointed that the FDA would rather bow to political pressure than trust women to make their own choices.