FDA Decision on Emergency Contraception Overruled

Plan B, the emergency contraception pill that prevents pregnancy after unprotected sex, has been the subject of much debate and disagreement since it was first approved by the FDA in 1999. The initial version of this contraception has evolved from a two-step pill series into a one-time dose, taken within 72 hours of unprotected sex. In 2006, the FDA approved over-the-counter purchase of the drug for women 17 and over; under the initial approval, those under 17 still required a prescription to purchase.  Most recently, the FDA determined that Plan B should be available as an over-the-counter option for any women or girls, with no prescription necessary, deeming  the drug safe and effective for adolescents to use properly without the intervention of a healthcare provider. This decision marked a monumental step forward in women’s access to contraceptive options and rights towards contraceptive decision-making.



Plan B One-Step, a high dose of the hormone levonorgesterel,
prevents pregnancy if given within 72 hrs of unprotected sex.

Unfortunately, however, the decision was short-lived. For the first time in our nation’s history, the Health and Human Services secretary publicly overruled the FDA’s decision, effectively refusing to allow over-the-counter provision of Plan B. Citing a lack of evidence around the safety of the drug for younger girls, Kathleen Sebelius acted within the same day that the FDA decision was made, raising concerns about whether 11-year olds would fully comprehend the product’s label and appropriate use. Legally, as the HHS secretary, Ms. Sebelius has the authority to overrule the FDA, but her act is unprecedented.  As to be expected, her actions ignited significant backlash among many. As a result of her appeal, Plan B will continue to be sold behind the counter at pharmacies, with young women under the age of 17 requiring a prescription from a medical provider.



Politics and women’s reproductive rights seem to exist in a state of fluctuating conflict, with scientific research and evidence somehow guiding arguments for both competing sides.  Arguments like those surrounding the Plan B debate point to the need for continued responsible research into women’s health issues to ensure that political and legal decision-making is firmly grounded in evidence, not ideology. The current evidence suggests that most women, including adolescents as young as 12, have consistently demonstrated a good understanding of how the drug is used and occasions that warrant its use. As teen pregnancy rates continue to rise, Plan B will remain a contested yet viable option to prevent undesired pregnancies. While Plan B is not an optimal first-line option for birth control, typical use of conventional birth control methods indicates a surprisingly high rate of failure (most often due to human error), pointing to the unique value of Plan B within the contraceptive market and the need to make this option accessible to women of all ages.