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.”
It’s worth noting that several studies have shown that girls as young as 11 understand the label and instructions well enough to use the drug safely and effectively. Indeed, Plan B may even be safer than the aspirin and ibuprofen that are already easily accessible – while overdoses of these medications can cause kidney and liver problems and even death,it is virtually impossible to overdose on Plan B.
Plan B will still be available to women ages 17 and older without a prescription, and to younger women that have a prescription. But this decision will keep Plan B behind the pharmacy counter for all women, which can create significant barriers to those that need the pill.
Many pharmacies are closed on evenings and weekends, even if the drugstores they operate in are still open; since Plan B is most effective if taken within 72 hours of having unprotected sex, such delays matter. Women have also reported encountering pharmacists that refused to sell them Plan B, because the medication violated their own personal beliefs.
The decision of Sebelius and HHS comes as a surprise, given how rarely the administration publicly overrules its own experts.
Sarah's first book, Generation Roe: Inside the Future of the Pro-Choice Movement, will be out March 2013. For more information, follow her on Twitter @saraherdreich, or check out saraherdreich.com.