Obama administration allowing Teva's Plan B for all ages

Trying to limit access to Teva Pharmaceutical Industries' ($TEVA) emergency contraceptive Plan B One-Step and other similar birth control drugs has been a long battle, but the government has finally decided to cut its losses. As of Monday, it will no longer be fighting for age-based restrictions on over-the-counter availability.

In a letter to U.S. district court judge Edward R. Korman, the administration said it would comply with his orders to make the drug available to women and girls of all ages without a prescription, The New York Times reports. In an FDA-issued statement, the agency said it planned to drop its appeal of those demands.

"To comply with the order, the FDA has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available OTC without any such restrictions," the statement said, as quoted by the New York Times. "Once FDA receives that supplemental application, the FDA intends to approve it promptly." After that, the Times reports, the FDA expects generic makers of the drug to seek similar arrangements, and it will most likely grant them availability without restrictions.

As Korman, in a New York appeals court, has already ordered the FDA to allow two-pill emergency contraceptives to be sold to customers regardless of age, this concession is the culmination of a legal fight fraught with political implications. Cecile Richards, the president of Planned Parenthood, called it a "huge breakthrough" and a "historic moment for women's health and equity," the NYT reports.

The issue of OTC, prescription-free availability of emergency contraceptives sparked intervention from HHS Secretary Kathleen Sebelius, who overruled the FDA's 2011 decision to make emergency contraceptives widely available and limited access for girls under 17. But pressure from women's rights groups and a federal judge's order to lift the restrictions resulted in an April decision from the FDA to allow Teva to sell Plan B One-Step to girls as young as 15. Sebelius' move drew fire--especially from Korman, who called it "obviously political" in his decision and also labeled the FDA's limits as "arbitrary, capricious and unreasonable."

- get the NYT story