Earlier today, the Obama administration overruled a decision by the FDA to allow teenage girls to purchase Plan B without a prescription. Even though FDA Administrator Margaret Hamburg said in a statement that the pill could be used safely by girls and women, Kathleen Sebelius and the Health and Human Services Department apparently felt otherwise. According to Hamburg:
“[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.”
For her part, Secretary Sebelius states that:
“The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. … The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.”
