After a busy two weeks of court rulings, the US Food and Drug Administration has finally come to an agreement with the federal courts concerning emergency contraception. One product, Plan B One-Step, will be put on drugstore shelves next to condoms, pregnancy tests, and tampons without any age restrictions. But it’s not there yet.
Currently both the $50 One-Step product—a hormone pill that prevents pregnancy if taken within three days of unprotected sex—and cheaper two pill generic versions sit behind the pharmacy counter and are only dispensed to those 17 and older when the pharmacy is open.
The FDA decided at the end of April to allow One-Step to be placed on shelves outside the pharmacy and lowered the age restrictions from 17 to 15. But the product is still only stocked in the pharmacy. Why?
Teva Pharmaceuticals, manufacturer of Plan B, must ship the one pill products with new packaging and labels before pharmacies can put the product out in the open on shelves, according to the FDA.
“We have not yet had [newly packaged] product shipped to stores and don’t anticipate they will be for another month or so,” Teva vice president Denise Bradley told me via email.
In order to completely lift the age restrictions on the product, the company must resubmit an old application to the FDA that shows the product is safe for girls of all ages to take. The FDA rejected that application before and encouraged Teva to ask for an age lowering to 15 instead.
Bradley said Teva is also working “with due speed to resubmit our application as soon as possible.”
FDA spokesperson Erica Jefferson told me once that occurs, the agency will take action to approve it quickly without any age restrictions; the label won’t need to be changed yet again, she added, before it can be sold without proof of age shown at the register.
Got all that?
As if this wasn’t confusing enough, there’s another hitch that’s angered reproductive rights activists who initially sued the FDA to force them to make emergency contraception over the counter to females of all ages.
Cheap two-pill generic versions likely won’t appear on shelves without any restrictions anytime soon because the FDA is also requiring an application to be filed in order to grant that status and no generic pill manufacturer has stepped up so far.
In the meantime, the FDA granted Teva three years of exclusivity to sell its Plan B One-Step over the counter when it approved it for 15-year-olds in April. Whether that will remain will be determined by the FDA after the new application is filed, according to Jefferson.
If it does, that means after millions of dollars and more than a decade spent on lawsuits, reproductive rights activists won’t have gained all that much for teenage girls and low income women. Many may still have a hard time purchasing emergency contraception because the only product at their easy disposal costs too much.
There may, though, be yet another twist in this soap opera of a story. In a decision accepting the Obama administration’s compromise to lift age restrictions on the Plan B One-Step product, U.S. District Court Judge Edward Korman warned the FDA on Thursday not to enter into exclusivity agreements with Teva—acknowledging the anger of women’s health groups.
He’s the same judge who ruled in early April that the Obama administration would need to put their politics aside and lift age restrictions on emergency contraception.
“This confers a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women,” Korman wrote in his decision.
We’ll soon see if the FDA agrees.Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.