Posted Dec 08, 2011 12:32 am CST
The Food and Drug Administration was ready to approve a Teva Pharmaceutical Industries Ltd. proposal to sell the company’s Plan B One-Step emergency contraceptive to girls under age 17 over the counter, without a prescription.
But, in an unusual move, Health and Human Services Secretary Kathleen Sebelius today blocked the FDA from doing so.
Her rejection of the Teva proposal leaves in place a system in which girls under 17 must obtain a prescription for Plan B and those 17 and over must ask a pharmacist for the drug, reports the Washington Post’s Wonkblog.
Concerns about offering the drug to younger teens on a non-prescription basis appear to be based more on objections to the risks involved in their having sex rather than any safety issue with the drug itself, according to a lengthy ABC News article about the federal agencies’ oversight of the emergency contraceptive.
ABAJournal.com (March 2009): “Judge: FDA Overstepped Bounds in Restricting ‘Plan B’ Contraceptive”