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Emergency Contraception: Plan B

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Abstract:

On August 24, 2006, the Food and Drug Administration (FDA) announced the approval of an application to switch Plan B, an emergency contraceptive, from a prescription-only drug to an over-the-counter (OTC) drug for women 18 years of age and older. Plan B will only be sold in pharmacies or healthcare clinics. It will continue to be dispensed as a prescription drug for women 17 years old and younger. Plan B is a brand of post-coital contraceptive that is administered within a few hours or days of unprotected intercourse. Emergency contraception prevents pregnancy; it does not disrupt an established pregnancy.

Approval of the switch to OTC status for Plan B has been controversial. Some Members of Congress urged the FDA to deny OTC status for Plan B. Individuals who are critical of the decision to switch to OTC believe that Bush Administration policy and FDA actions were based on political and ideological considerations rather than on sound science. Conservative religious and pro-life groups believe Plan B may increase unsafe sexual activity and should be used only under the supervision of a healthcare professional and, therefore, should not be available OTC. Their major concern with Plan B, however, is that it might prevent the implantation of an embryo in the uterus, which to pro-life groups constitutes abortion. However, the medical community does not consider prevention of implantation to be an abortion, and FDA does not classify Plan B as an abortion drug.

FDA approved the first hormonal emergency contraceptive, Preven, in 1998 as a prescription-only drug; Plan B was approved as a prescription drug in 1999. Emergency contraceptives are currently available without a prescription in more than 40 countries. The application to switch Plan B to over-the-counter status was submitted to FDA in April 2003. Women's health advocates claim that OTC status will improve access to the drug, thereby reducing the number of unintended pregnancies and reducing the number of abortions.

The Office of Violence Against Women within the Department of Justice (DOJ) has developed guidelines for the treatment of sexual assault victims. The guidelines, released in September 2004, have been criticized by numerous organizations because they do not mention offering emergency contraception to female rape victims. In January 2005, a letter signed by 97 Members of Congress was sent to the Director of the Office on Violence Against Women expressing concern over the failure to mention emergency contraception and urging that the guidelines be changed to include such information.

The bills directly related to Plan B that were introduced in the 109th Congress have two purposes: to ensure that Plan B is made available to sexual assault victims (H.R. 1214, H.R. 3171, S. 20, S. 844, H.R. 1709, H.R. 2928, S. 1264, and H.R. 2635) and to encourage education and provide information about Plan B (S. 20, S. 844, H.R. 1709, and H.R. 3326). Another bill, H.R. 6235, would require the HHS Secretary to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by women under the age of 18. This report will be updated as events warrant.