Plan B One-Step is a single-dose emergency contraceptive pill that contains higher levels of levonorgestrel, a hormone found in some birth control pills, and has been available in the U.S. since 2009. Its effectiveness is linked with timeliness of use: the drug should be taken within 72 hours of intercourse. The Food and Drug Administration (FDA), after reviewing the scientific evidence on its safety and effectiveness, recommended that it be available–without prescription–to females of any age.
On December 7, 2011, Secretary of Health and Human Services (HHS) Kathleen Sebelius overruled this FDA recommendation. While the Secretary of HHS has the authority to override the FDA, The New York Times reported that this issue was the first time a HHS secretary has publicly overruled the FDA. Secretary Sebelius’ action limits an attempt by the FDA to improve the accessibility of Plan B One-Step among young girls, but it does not affect the legality of the drug. Plan B One-Step remains available, without a prescription, to women who are 17-years old and older; and it is still approved for use, with a prescription, for females who are younger than 17.
Sebelius argued that there should be no change in the current law requiring females younger than 17 to obtain a prescription for Plan B One-Step because they require health-care provider guidance to use the pill properly and safely (to see Sebelius’ counterstatement to the FDA’s recommendation, click: http://www.hhs.gov/news/press/2011pres/12/20111207a.html). However, as FDA Commissioner Dr. Margaret Hamburg stated, “Based on the information submitted to the agency, [the FDA’s] CDER [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.” Further, young girls are able purchase a variety of over-the-counter medications and personal products that could be harmful in large doses, such as Tylenol, with no ill effects. President Barack Obama had the opportunity to overrule Sebelius’ decision, but instead agreed with her, noting that he felt uncomfortable, as a father, with the FDA’s decision.
What’s at play here? What’s going on in this dance between science and good health policy? Did upcoming presidential race play a role here? Are there additional moral or ethical considerations about the proper age for emergency contraception? What’s going on?
How much should, or do, data really matter in creating health policy? How we talk about – frame – this and other politically charged health issues matters. Consider the language used in various news sources covering the issue. The emotionally charged responses to this specific drug from both evidence-based and ethical-based sides merge to create a unique and complicated discussion. As we launch into an election year, how can we expand the conversation on the topic with our peers and colleagues to further consider the multiple dimensions influencing the availability and accessibility of Plan B for women of all ages across the U.S.?
December 13, 2011 Coverage Update: 14 U.S. Senators, including Minnesota’s Al Franken, have called for further explanation of Sebelius’ decision made on December 7, 2011. The letter–defending the importance of using science to create policy—asks Sebelius for “specific rationale and scientific data” behind limiting Plan B’s accessibility. To see the letter and co-signers, visit: http://murray.senate.gov/public/index.cfm/newsreleases?ContentRecord_id=77e3d54b-bb6b-4c7c-9f05-bfe8c8d3b304. Sebelius has not yet released a response.