Teva Pharmaceuticals Requests FDA Remove Age Restrictions for Non-Prescription Plan B Pill

February 14, 2011 — Teva Pharmaceutical Industries last week announced it has asked the FDA to allow its Plan B One-Step emergency contraceptive to be sold without a prescription to women of any age, Reuters reports. The pill currently is available without a prescription only to girls and women ages 17 and older.

Women's health groups since 2001 have sought wider access to the drug, first approved in 1999, but their efforts stalled during the Bush administration amid protests from Congress that FDA was allowing politics to play a larger role in its decision than science, according to Reuters. FDA in 2006 approved the drug for "behind the counter" sales to women 18 and older, but later lowered the age to 17. Women's groups sued the agency over its handling of the drug, leading to a 2009 court order that the agency reconsider its decision.

Teva submitted additional data to FDA detailing the actual use of the drug among young women ages 11 to 16. Susan Wood, former head of the FDA Office of Women's Health who left the agency in protest of its decisions regarding Plan B, said the decision "should be straightforward," as FDA has all of the information it needs to decide on wider access. The agency is expected to rule within 10 months (Heavey, Reuters, 2/11).