After a court battle that dragged on for years, the Food and Drug Administration announced on Thursday that Teva Pharmaceutical Industries' Plan B One-Step over the counter morning-after pill will be available for sale for women of all ages, CBS News reports.
According to FiercePharma, the head of the FDA, Margaret Hamburg, was in a political fight with her boss, Health and Human Services Secretary Kathleen Sebelius, in a court battle that went on for several years. On April 5, 2013, U.S. District Judge Edward Korman of New York issued a court order that allowed for the FDA to approve Plan B One-Step for sale to women of all ages, following a previous administration limit on making it available. Judge Korman called the previous age limitation "arbitrary, capricious and unreasonable."
"Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," the FDA's Janet Woodcock said in a press release.
Plan B-One Step (levonorgestrel) is an emergency contraceptive that drastically reduces the chance of a woman becoming pregnant after unprotected sex, a form of the morning-after pill. It works best when taken three days after sexual intercourse, and will stop not a pregnancy if a woman is already pregnant, as no evidence exists it will cause harm to a fetus.
Currently there are three types of morning-after pills for sale in the U.S., including Plan-B One Step, Plan B and ella. Plan B is available for women 17 and older over the counter, requiring a prescription for those under the age limit. Ella requires a prescription regardless of a woman's age. Plan-B One Step will be the first FDA-approved drug available to women of all ages without a prescription.
The FDA was preparing to allow the sale of morning-after pill without age restrictions in 2011, citing the pill's safety and effectiveness. However, Secretary Kathleen Sebelius rejected the move, a decision that went against her scientific advisory panel, and outraged critics who claimed that an age barrier on the drug would make it very difficult for some women to access the product.
"Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women, but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a press release at the time. "These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."
President Obama was supportive of the age restriction on the morning-after pill at the time, backing Sebelius's decision to reject wider access to Plan B. "As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine," he had previously said, according to CBS News.
The Obama administration had said that they planned to appeal Judge Korman's decision to lift the barrier on age limits, upsetting Nancy Northup, president of the Center for Reproductive Rights, which filed the lawsuit that prompted Korman's ruling.
"We are deeply disappointed that just days after President Obama proclaimed his commitment to women's reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions," Northrup said.
On June 10, the federal government said that it would withdraw the appeal and comply with Judge Korman's decision. On June 13, a federal judge approved the government's proposal to remove the age restrictions on Plan B.
