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UPDATE: Plan B One-Step In the Works to Hit Store Shelves
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
In long overdue news, unrestricted access to Plan B One-Step is actually in the works. Yesterday, Federal Judge Edward Korman approved the FDA’s proposed plan from earlier this week to make Plan B One-Step available without any age or point-of-sale restrictions.
Judge Korman originally ordered all levonorgestral-based emergency contraceptives to be moved OTC for women of all ages back in April. After much back and forth, the Department of Justice announced on Monday that they would comply with his order to make Plan B One-Step (the leading brand of emergency contraception) available without restrictions. Now that Judge Korman has accepted this plan of action, Plan B’s manufacturer (Teva) will submit an application to the FDA, which will likely lead to new labeling and packaging for the drug. Once the FDA approves this, they’ll work to get the drug on store shelves as soon as possible.
But Judge Korman made it clear that there is still work to be done here. In his letter yesterday, he notes that allowing one brand to have exclusivity may still deter some women from getting the drug, since it would mean that lower-cost generics remain behind the pharmacy counter.
“I think his commentary does not have any limiting power over the fact that it is now in the FDA’s and Teva’s hands to work this out,” says Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project.
So when can we expect to see it next to the condoms? Unfortunately, the FDA application and approval process will take time, and experts can’t venture a guess as to how long we’ll have to wait. Check back soon for any updates.
More from Women’s Health:
Obama Administration Reverses Course on Emergency Contraception
Should Birth Control Be Over The Counter?
What is Emergency Contraception?
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