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For the next three years, said the FDA on Monday, Plan B One-Step will be the only brand of the morning-after pill that will be allowed to be sold over the counter with no age restrictions.
For the next three years, Plan B One-Step will be the only brand of the morning-after pill that will be allowed to be sold over the counter with no age restrictions.
That's what the Food and Drug Administration (FDA) decided on Monday, noting that this period of "exclusivity" will last until April 30, 2016.
FDA spokeswoman Stephanie Yao noted in a statement to KPCC that drug companies seeking to manufacture new, generic versions of the one-step (one-pill) morning-after contraception may still win FDA approval. But they will not be able to sell their product to girls younger than 17 – at least until Plan B's exclusivity expires in 2016.
What this boils down to:
- Anyone can buy the brand-name, Plan B One-Step pill.
- The only people who will be able to buy generic versions of the one-step morning-after pill are girls 17 and older, and no prescription is required – only age verification.
- Girls younger than 17 won't have any access to generic one-step morning-after pills – at all.
- As noted by NPR, the two-pill (two-step) version of the morning-after pill will remain available to any girls who can verify that they're 17 or older or any girl younger than that with a prescription.
It's complicated, in other words.
In South L.A., the morning-after pill can be an effective tool in combatting the area's high teen pregnancy rate. The latest public health data indicates the area sees more than 51 teen births for every 1,000 live births, which is by far the highest teen birth rate in Los Angeles County.
But it's not a cheap pill. According to the Boston Globe, Plan B retails for about $50 a pill. That's considerably more expensive than its generic counterparts, which can sell for as low as $20 each. But those less expensive options still carry age restrictions and/or require a prescription.
That can be a problem for girls and women who don't have reliable access to health care because time is of the essence when it comes to the morning-after pill: It's most effective at preventing unintended pregnancies when taken within 72 hours of having unprotected sex.
Plan B, which is manufactured by Teva, was approved for over-the-counter sale to all women of reproductive age in June, after a long, complex battle between federal health officials, the Obama Administration and the courts.
There are some critics of the resulting convoluted restrictions on who can buy what pill.
Dr. Cesar Barba, the interim medical director at UMMA Community Clinic in South Los Angeles, describe the approval of Plan B One-Step for wider sale and the remaining restrictions on cheaper generics as taking "one step forward and kind of a half-step back" in a June interview.
"It's important for access," Barba said at the time. "It's important to be able to give people options without having to go to their doctor in regards to birth control options."