Obama administration drops appeal for age limit on OTC Plan B
Emergency contraception use up sharply
The Obama administration announced this week that it will not appeal a Federal judge's decision earlier this year to remove age restrictions on the emergency contraceptive Plan B One-Step.
The Justice Department sent a letter to Judge Edward R. Korman of the U.S. District Court's Eastern District of New York informing him it would no longer challenge his April decision to make the Plan B One-Step available over-the-counter for all ages instead of requiring a prescription for girls aged 16 years and younger, the New York Times reported.
Planned Parenthood Federation of America president Cecile Richards praised the move, calling it "a huge breakthrough for access to birth control and a historic moment for women's health and equality," in a press release.
“We encourage manufacturers of emergency contraception to request new labeling quickly and for the FDA to approve all such applications immediately to finally make this birth control option available without restrictions,” Richards said.
Plan B One-Step is expected to reach drugstore shelves in coming weeks, but drug maker Teva must first submit a supplemental application to the FDA for permission to sell it over-the-counter to all ages.
"Once FDA receives the supplemental application, the FDA intends to approve it promptly," the agency said in a statement.
The government's decision not to pursue further legal action blocking OTC emergency contraceptives without age restrictions comes after a Court of Appeals for the Second Circuit in New York ruled last week that a generic, two-pill version of Plan B be made available immediately.
After a week of deliberation, the Obama administration decided that Plan B One-Step, which involves taking one pill instead of two, would be easier for young girls to understand.
The Center for Reproductive Rights, the organizations representing the plaintiffs in the case, announced it will file an objection to the government's decision because it does not cover both the one- and two-pill versions of the contraceptive, noting that there is no difference in safety between the two options.