U.S. 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.
There are many known side effects to Plan B One-Step®, including nausea, which is experienced by 1 in 4 women, as well as vomiting, abdominal pain, dizziness, and breast tenderness. But beyond these issues, which occur less frequently, doctors say Plan B is extremely safe and effective.
One reason the morning-after pill is safe is it contains no estrogen, unlike most birth control pills. Plan B has Levonorgestrel, a progestin hormone, which means it does not have the risks of blood clotting that pills containing estrogen carry. Also, Plan B is a single-dose drug, not something women take continuously.
Health advocates argue restricting access to emergency contraception leaves young teens facing unwanted pregnancy. According to Guttmacher Institute, nearly 750,000 girls aged 15-19 get pregnant each year in the U.S., and 59% of those pregnancies are carried to birth.
The LA Times reports that similar “morning after” products are available over-the-counter with no specific age restrictions in other countries such as Belgium, Sweden, the Netherlands, South Africa and Thailand. In Britain, France, Australia and China, emergency contraception can be purchased from pharmacists without a prescription but is kept behind the counter, as it is in the U.S. In Britain, buyers have to be at least 16. In France and Belgium, the medication is provided free of charge for girls younger than 18 without an age restriction.
In 2006, a two-dose formulation of the Plan B drug was first approved for over-the-counter sale in the U.S. for women 18 years and old. In 2009, over-the-counter status for Plan B One-Step® was granted for females 17 and older, thus the products are kept behind the counter.
The FDA review for those decisions dates back to ’03, when an independent panel of reproductive health experts voted 23-4 to approve Plan B for all females of child-bearing potential, according to FDA spokeswoman Erica Jefferson.
Teva Pharmaceuticals appealed to the FDA earlier this year to remove the prescription-only status for girls under 17. They submitted data to support their application specifically addressing the issues raised by dissenting committee members, including evidence that adolescents could understand the package labeling.
The FDA reviewed all the data and decided “approval” was in order. Commissioner Hamburg said in a statement that she agreed with the analysis. “There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” she wrote. Secretary Sebelius, however, directed Hamburg to deny Teva’s application.