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UPDATE: Plan B One-Step In the Works to Hit Store Shelves

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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.

photo: Mert Toker/Shutterstock 

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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UPDATE: Obama Administration Reverses Course on Emergency Contraception

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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.

Big news: after months of back-and-forth between the courts and the Obama administration, the Department of Justice announced yesterday that they will comply with a judicial order to make Plan B One-Step available over-the-counter for women of all ages. This is a reversal in policy for the Obama administration, which originally blocked full OTC access to emergency contraception when it was proposed in 2011, and has been fighting to limit full access since then.

The conflict heated up again back in April 2013, when Federal Judge Edward Korman ordered that all levonorgestral-based emergency contraceptives must be available over-the-counter without any point-of-sale restrictions. As expected, there was plenty of backlash: the DOJ appealed the decision; the FDA tried to compromise with looser age restrictions on Plan B; and the Second Circuit Court of Appeals even got involved.

Yesterday, the DOJ issued a letter to Judge Korman announcing that the FDA and the Department of Health and Human Services plan to lift all age and point-of-sale restrictions on the brand name Plan B One-Step in a timely manner. If Judge Korman accepts this new plan, Plan B’s manufacturer would submit a supplemental new drug application to the FDA (which is routine when a drug moves over the counter), and the FDA will approve it without delay.

But here’s where things get (more) complicated: the letter hints that Plan B will get exclusivity as the only morning after pill allowed on store shelves without restrictions, says Susannah Baruch, interim president and CEO for the Reproductive Health Technologies Project. That means that all generic and two-pill doses (which can cost anywhere from $ 10 to $ 20 less than the name brand) will remain behind the pharmacy counter—and only available without a prescription for women 17 and older. That may not seem like a huge deal, but the result is that if you get to the drugstore after the pharmacist has left for the day, you may end up shelling out more cash for the same medication.

So what’s the next step? Now, we’re waiting to see if Judge Korman accepts this new plan, or if he decides to push for complete OTC access for all emergency contraception—including the generics. If he does accept, this new plan would replace last week’s ruling by the Second Circuit Court, which said only two-pill versions could be available OTC.

Check back soon for more updates on your access to the morning after pill.

photo: iStockphoto/Thinkstock

More from Women’s Health:
Should Birth Control Pills Be OTC? 
Celebrating the Legalization of Birth Control
What is Emergency Contraception? 

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UPDATE: DOJ Appeals Emergency Contraception Ruling

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If you were hoping (like the rest of us) that the morning after pill would be as accessible as condoms by now, you’ll have to wait a little longer. On May 1, the Department of Justice appealed the decision to make all forms of levonorgestral-based emergency contraception available over the counter for women of all ages. This happened just one day after the FDA approved Plan B One-Step for sale on store shelves to women 15 and older.

Back on April 5, we reported that Federal Judge Edward Korman ordered the FDA to make emergency contraceptives available over the counter—right next to the condoms and pregnancy tests—for women of all ages. The Department of Justice had 30 days to make an appeal, and they made it yesterday. Their argument: That the court did not have the authority to tell a federal agency like the FDA how they can treat a product, says Susannah Baruch, interim president and CEO of Reproductive Health Technologies Project. They asked Judge Korman for a stay, or a temporary suspension of the case. Whether or not he grants it, the DOJ can continue their appeal with the Second Circuit courts. The bottom line: It can take months for women of all ages to have complete, unburdened access to emergency contraception.

Luckily, this appeal does not affect the FDA’s recent approval to sell Plan B One-Step over the counter to women age 15 years and older (a more restricted version of what the federal judge asked for on April 5). This decision came on April 30, when the FDA approved a new application by Teva (Plan B One-Step’s manufacturer). The good news: This increases availability since you won’t have to search for an open pharmacy counter to get the pill, and it drops the age requirement down to 15. The bad news: It still means you’ll have to show a government-issued ID to a store clerk, which may be an issue for anyone without an ID or anyone who forgets it at home. Essentially, the age and point-of-sale restrictions are still there—they’re just tweaked a little. Plus, this only refers to Plan B One-Step, not the two-pill dose nor any of its generics.

You can expect to see Plan B One-Step out from behind the pharmacy counter (and available to women 15 and older) in the next few months, says Baruch. They are currently working on a new plastic packaging, which will make it easier to store on a shelf without worrying about theft or tampering. Since it is a very small and expensive product, it will likely contain an anti-theft device, placed behind an anti-theft covering, or stored behind the cashier, says Baruch. A store clerk will also require a government-issued ID at the time of purchase. While this is all super inconvenient, it’s still easier than searching for a 24-hour pharmacy counter.

“There is simply no medical justification for the FDA’s move this week or for the administration’s refusal to follow the court order to put Plan B on the shelves,” says Baruch. “There is only political interference in scientific decision-making, and we will continue to fight for full access to emergency contraception for every women—every woman without restrictions—when and where she needs it.”

In the meantime, keep checking back for the latest coverage of these proceedings.

photo: iStockphoto/Thinkstock

More from Women’s Health:
FDA Approves Plan B One-Step For Sale Over the Counter
The Morning After Pill May Soon Be Over the Counter
6 Things You Need to Know About the Morning After Pill

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