Health Female Adda
1 year ago
FDA Moves Forward With OTC Plan B-One Step Approval

Since April 2013, we’ve been closely following the legislation ordering emergency contraception (like Plan B One-Step and its generics) to be accessible over the counter, without any age or point-of-sale restrictions. Check out the latest developments below, and continue checking back for more coverage.  

Emergency contraception is now closer to making its debut on store shelves. Yesterday,the FDA approved the use of Plan B-One Step without a prescription for women of all ages. This announcement marks the FDA’s compliance with the April 5 order by Federal Judge Edward Korman, which ordered the FDA to make levonorgestral-based emergency contraceptives available without any age or point-of-sale restrictions.

While Korman originally asked that all morning after pills of this type be available on store shelves, his back-and-forth battle with the DOJ ended in a compromise on June 10, when they announced that they would make Plan B One-Step (the most popular brand on the market) available without restrictions and Korman accepted this. As a result of that, Plan B’s manufacturer provided a supplemental new drug application to the FDA, and the FDA approved this on Thursday.  The only downside: this still means that the cheaper generic and two-pill versions of emergency contraception will remain behind the pharmacy counter.

This approval by the FDA does mention that Plan B One-Step is a drug that is safe and effective for women of all ages. It also reinforces the point that emergency contraception will not stop a pregnancy if the woman is already pregnant and that there is currently no medical evidence to suggest that it would harm a developing fetus.

While there is no word yet on when we can expect to see Plan B next to the condoms, it seems encouraging that the FDA was speedy in their approval of the new guidelines. Check back soon for updates.

photo: alpimages/Shutterstock
More from Women's Health:
Plan B One-Step in the Works to Hit Store Shelves
Obama Administration Reverses Course on Plan B 
What Is Emergency Contraception? 

9 Views    
Facebook Facebook Twitter Linkedin Google Pinterest

Related Articles

Refer your 10 female friends! Earn Instant 500