FDA Approves Plan B for Women 15 and Up

Today, the U.S. Food and Drug Administration announced that it has approved the use Plan B One-Step, an emergency contraceptive, without a prescription by women 15 years of age and older.

The pharamaceutical company that produces Plan B One-Step, Teva, originally applied to make this contraceptive available over the counter for all females of reproductive age in December of 2011, but the FDA rejected the application. Now that Teva has amended the application to include only women above the age of 15, the FDA has approved.

Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse. It is a single-dose pill that is effective in decreasing the possibility of unwanted pregnancy if taken within 3 days after unprotected sexual intercourse.

Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus. Also, Plan B also does not protect against the transmission of AIDs HIV or any other sexually transmitted disease.

Following the FDA's approval, FDA Commissioner Margaret A. Hamburg, M.D. said this:

Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States. The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.

All women who request these pills will be required to verify their age. A customer who cannot provide age verification will not be able to purchase the product.

The product will now be available in retail outlets with an onsite pharmacy, where it will be found (typically) in in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.