Malpractice News

May 9, 2013

FDA approves new regulations for emergency contraceptive

As of April 30, the Food and Drug Administration has approved the use of Plan B One-step emergency contraceptive by women 15 years and older. Originally, Teva Women’s Health had submitted an application to have the drug made available over the counter to all women of child-bearing age. This application was not approved, which is when Teva revised its application.

Proof of age required

One qualification being added to the contraceptive packaging is: “not for sale to thus under 15 years of age *proof of age required* not for sale where age cannot be verified.” In addition, all cartons will have an anti-theft security tag attached.

Plan B designed to work when birth control fails

Plan B One-Step is intended for use when unprotected intercourse occurs or when another form of birth control fails. It is a single does pill which reduces the possibility of pregnancy when consumed within 3 days of intercourse. However, “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.”

15-year-olds proven to understand use of Plan B

FDA Commissioner Margaret Hamburg, M.D. said of the new measure, “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.”


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