Health and Human Services Secretary Kathleen Sebelius recently overruled The Food and Drug Administration (FDA) announcement that Plan B One-Step® would be permitted for sale “over-the-counter” — no prescription required — for all ages. Based on Sebelius’s decision, the emergency contraceptive that’s commonly referred to as the “morning-after pill” will remain available for girls 16 and under by prescription only. This is the first time that any Health and Human Services secretary has overruled an FDA decision.
Reproductive health advocates were unhappy about the development while proponents of “conservative family values” hailed Secretary Sebelius.
Both Sebelius and Margaret Hamburg, commissioner of the FDA, argue they made their decisions based on scientific evidence. Let’s take a closer look:
Plan B is a single, 1.5-milligram dose of the synthetic hormone “Levonorgestrel” that can decrease the chances of becoming pregnant by an estimated 59-94% if taken within five days (120 hours) of unprotected sex. It’s manufactured by Israel-based Teva Pharmaceutical Industries (NASD: TEVA), which has U.S. headquarters in North Wales, PA.
Jill Adams of the Los Angeles Times reports the fairly broad percentage range stems from a combination of factors including the uncertainty around how likely a women is to get pregnant after a single sexual encounter and where she is in her monthly cycle. Also critically important is when the woman ingests the emergency contraceptive: Pregnancy-prevention rates are highest — upwards of 80% — on the first day after intercourse.
Adams quotes UCLA OB/GYN, Dr. Angela Chen, saying, “The key is to take it very early, very quickly. Once the egg is released, it’s less effective.”
The medicine essentially delays ovulation so that sperm cells have a reduced chance of finding an egg to fertilize before dying while also changing the lining of the female reproductive tract in a way that slows sperm and egg transport, reducing the chances of the two coming together. These lining changes can also inhibit implantation of a fertilized egg, which is consider abortion by anti-abortion advocates. However, Plan B does not interfere with pregnancy once implantation has taken place.