The FDA has announced its approval of an amended application submitted by Teva Womens Health, Inc. to market Plan B One-Step (levonorgestrel) for use without a prescription by women ages 15 and older.
After the FDA did not approve Tevas application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women ages 15 and older without a prescription.
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code, prompting a cashier to request and verify the customers age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
Teva will make the product available in retail outlets with an onsite pharmacy, where it generally will be available in the family planning or female health aisles. The product will be available for sale during the retailers normal operating hours whether or not the pharmacy is open.
Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within three days after unprotected sexual intercourse.
Plan B One-Step will not stop a pregnancy when a woman already is 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,” FDA Commissioner Margaret A. Hamburg, MD, said in a news release.
The approval is based on an actual-use study and label comprehension data submitted by Teva showing that women 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a healthcare provider.
Because the product will not protect a woman from HIV or AIDS or other sexually-transmitted diseases, young women who are sexually active should remember to see a healthcare provider for routine checkups, according to the FDA. The 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 it plans to educate consumers, pharmacy staff and healthcare professionals about the products new status. It also has indicated its willingness to conduct an audit of the age verification practices after the product is approved to ensure the age limitation is being followed.
Recent court ruling
On April 5, a federal judge in New York ordered the FDA to grant a 2001 citizens 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, Tevas application to market Plan B One-Step for women 15 and older was pending with the agency prior to the ruling.
The FDAs approval of Tevas current application for Plan B One-Step is independent of that litigation and is not intended to address the judges 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 ages 15 and older.
Aside from Plan B One-Step, the other emergency contraceptive drugs marketed in the United States are 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 younger than 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 Tevas application for Plan B One-Step does not affect the prescription status of these other drugs. Teva Womens Health is based in North Wales, Pa.