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.
“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Margaret A. Hamburg, M.D. “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.”
Because the product will not protect a woman from HIV or AIDS or other sexually-transmitted diseases, it is important that young women who are sexually active remember to see a health care provider for routine checkups. The health care provider should counsel the patient about, and if necessary test her for, sexually-transmitted diseases, discuss effective methods of routine birth control, and answer any other questions the patient may have.
Teva has indicated that it plans to educate consumers, pharmacy staff, and health care professionals about the product’s new status. It has also indicated its willingness to conduct an audit of the age verification practices after the product is approved to ensure that the age limitation is being followed.
On April 5, 2013, a federal judge in New York ordered the FDA to grant a 2001 citizen’s petition to the agency that sought to allow over-the-counter access to Plan B (a two dose levonorgestrel product) for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions. However, Teva’s application to market Plan B One-Step for women 15 and older was pending with the agency prior to the ruling.
The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling.
The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older.
There are currently three emergency contraceptive drugs marketed in the United States – Plan B One-Step, Plan B, and ella. Plan B, available from generic manufacturers, uses two doses of levonorgestrel (.75 mg in each tablet), taken 12 hours apart, and requires a prescription for women under the age of 17. Ella (ulipristal) is a prescription-only product that prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected sexual intercourse. The approval of Teva’s application for Plan B One-Step does not affect the prescription status of these other drugs.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Reversing a previous decision, the FDA approved the “morning-after pill,” aka Plan B
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