A morning-after birth control pill that set off a bruising court battle and forged an unusual alliance between President Obama and social conservatives has hit store shelves and will become increasingly available without any restrictions.
Teva Pharmaceuticals worked this month to repackage its “Plan B One-Step” pill so it could be sold to all ages without a prescription, the result of a federal court order in April that bluntly criticized the Obama administration for thwarting attempts to make the emergency contraceptive available to girls younger than 17 without a prescription.
Teva spokeswoman Denise Bradley said Friday the company has “already seen the product on sale” in store aisles.
“We believe we’ll see more widespread availability in the coming weeks and continue to work with our retail customers to help with the transition,” she said.
Labeling plans submitted to the FDA feature the words, “New! Now Available Over the Counter” in the upper-left corner of the package.
The Justice Department initially appealed the ruling that mandated the pill’s broad accessibility, and Mr. Obama reiterated longstanding concerns about the drug’s effect on young teen girls.
Social conservatives also cried foul, saying contraceptive decisions should be made between teens and their parents and that unfettered access to emergency contraception was a bad idea.
But after an adverse ruling in the appellate courts, the Justice Department decided to drop its appeal and make the drug as easy to purchase as aspirin.
In June, the Food and Drug Administration approved Teva’s request to sell Plan B One-Step without restrictions.
The company appears to be ahead of its self-imposed timeline. Earlier this month, Ms. Bradley told The Washington Times that the company hoped to have the repackaged drug on store shelves by Aug. 1.
But reproductive rights advocates say more needs to be done to make the drug affordable.
The American Society for Emergency Contraception this month said its survey of 400 pharmacies found that Plan B One-Step costs nearly $48, or slightly more than the average generic price of $42.
“Even the lowest retail prices for [emergency contraception] are beyond the reach of many women,” the society said. “In order for EC to be truly accessible to all who need it, the generic products must be made available without restrictions on the shelf along with the branded products, and all prices must be lowered to a more affordable level.”
The Reproductive Health Technologies Project criticized the FDA’s decision last week to grant exclusive marketing rights to Teva for three years.
As a result, other drug makers cannot sell a generic version of the pill to customers under age 17 without a prescription until the exclusivity period ends.
“Basically, it is yet one more missed opportunity for the Administration to get it right on emergency contraception,” RHTP President and CEO Jessica Arons said in a news release.
Teva declined to comment on the FDA’s decision.