FDA drops over-the-counter age limit for Plan B One-Step

The Food and Drug Administration has approved over-the-counter use of an emergency contraceptive called Plan B One-Step for use by all women and girls who can potentially bear children, no matter how young, the agency announced Thursday.

But the move does not approve similar non-prescription use for other generic emergency contraceptives.

The FDA says it “has fulfilled its commitment” with a court order issued by U.S. District Judge Edward Korman, according to an agency release.

The approval of the single-dose pill manufactured by Israel-based Teva Women’s Health comes a little more than a week after the Obama administration announced that it would comply with the court order. The FDA asked Teva to apply to seek approval for over-the-counter use without age restrictions, which the agency then approved.

The drug works by flooding the body with a synthetic hormone called levonorgestrel, which blocks ovulation and thus prevents pregnancy. It only works before a pregnancy takes hold and has not been shown to harm a developing fetus. Side effects can include nausea, stomach pain and dizziness.

Plan B One-Step stirred up controversy in 2009 when it was approved for use without a prescription for women and girls ages 17 and older. Girls younger than age 17 could also purchase the $50 pill, but only with a prescription. In April, the age limit was dropped from 17 to 15. Now the drug will be made available over the counter to all females who could potentially conceive a child.

But the FDA has not approved alternative brands or generic forms of the drugs. Although other companies can apply to have their version of the contraceptive approved for non-prescription use, the agency could potentially “grant Teva ‘marketing exclusivity,’” according to an earlier story on the agency’s move — a political two-step decried by some women’s health advocates.

The issue remains politically charged, given the possibility that young girls could potentially buy the pill after engaging in unprotected sex.

“President Obama has said he was bothered by the idea of 10- or 11-year-old girls buying the drugs as easily as ‘bubble gum or batteries,’” according to The Times’ earlier coverage.

Korman has accused the Obama administration of dragging its feet during the federal court proceedings.