Tag Archives: Kathleen Sebelius

Morning-After Pill Still Strong

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June 20 marks the fifth anniversary of the U.S. Food and Drug Administration’s (FDA) approval of over-the-counter Plan B One-Step, a type of “morning-after pill” (itself a type of emergency contraception), without age restrictions. The first morning-after pill was approved by the FDA in 1998, but political backlash prevented easy access to it for more than a decade.

In 2011, the FDA was poised to approve over-the-counter access for Plan B for people 17 and older. The Department of Health and Human Services intervened, raising concerns that young girls might not be able to use the drug safely — even though studies have shown that Plan B is safer than taking an aspirin. The Obama administration, however, claimed that younger people still needed a prescription to ensure they understood the proper use of Plan B.

Access to Plan B gives teenagers another chance to avoid unwanted pregnancy.

The wrangling continued. In early April 2013, a federal district court judge dismissed that claim, stating that the Obama administration’s restrictions were a “politically-motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.” On April 30, the FDA announced that the morning-after pill would be available without prescription to users 15 years of age and older.

The fight to expand over-the-counter access for the morning-after pill wasn’t over. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated that “over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.” It wasn’t until June 2013 — five short years ago this week — that the FDA approved Plan B One-Step for over-the-counter sale without age restrictions, after the Department of Justice dropped its appeal. In February 2014, certain generic morning-after pills were similarly approved.

Today, let’s celebrate this expanded access to the morning-after pill by reviewing what we need to know about this important form of contraception. Continue reading →

Mythbusting: Does Emergency Contraception Cause Abortion?

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[T]he Centers for Disease Control and Prevention reported recently that one in nine sexually active women, or 5.8 million women, has used emergency contraceptive pills, such as Plan B. Emergency contraception is a woman’s back-up method to prevent an unwanted pregnancy, and women report using it when they feel their contraceptive method has failed, such as a broken condom, or they do not use a regular contraceptive like birth control pills.

The latest scientific evidence shows that Plan B works mainly by delaying ovulation — not by affecting a fertilized egg.

Some conservative politicians have been stating publicly that emergency contraceptive pills (ECPs), such as Plan B, cause abortions. They may believe that life begins at conception (fertilization of the egg by the sperm) and argue that ECPs disrupt a fertilized egg’s ability to implant in the uterus, which they consider equivalent to abortion. The American Congress of Obstetricians and Gynecologists and experts from the Food and Drug Administration and the National Institutes of Health consider a pregnancy to be established when a fertilized egg settles itself on the wall of the uterus — implantation. A woman is most likely to become pregnant when she ovulates, which is usually about two weeks before her next period. Sperm can live for up to three days. So, if an egg is fertilized, there are still possibly six to 12 days before the implantation may take place.

When ECPs were first developed and information about them was submitted to the FDA for market approval, the drug manufacturers included mention of every possible mechanism on how the pill might work to prevent pregnancy. This included wording about preventing or delaying ovulation, making the sperm or egg less able to meet, and possibly preventing implantation. However, the latest scientific evidence has shown that ECPs such as Plan B mainly work by delaying ovulation — Plan B does not affect implantation and has no effect on existing pregnancies. Several prominent researchers have stated that if in fact Plan B disrupted implantation, it would be 100 percent effective at preventing a pregnancy, and that is not the case. Continue reading →

That Was Then, This Is Now: A History of Emergency Contraception

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plan bThe following guest post comes to us via Morganne Rosenhaus, community engagement coordinator for Planned Parenthood Arizona.

For more than 10 years, emergency contraception has been the “poster child” for what it looks like when politics trumps science, again and again and again. Women’s health advocates, women’s health care providers, and researchers have argued for years (and two different presidential administrations) about the safety of emergency contraception and the importance of its place on the shelf, between the pregnancy tests and the condoms.

The age restrictions on emergency contraception have been in flux. Where do things currently stand?

In 1999, Plan B was approved by the Food and Drug Administration (FDA) as a prescription-only product (all new drugs are first approved as prescription-only). In 2003, the manufacturer of Plan B filed an application with the FDA to make it available over-the-counter (OTC). An FDA Advisory panel voted to recommend Plan B for OTC access with no age restriction. Then political turmoil ensued. You can read all the details here in this handy timeline.

In 2006, Plan B was approved for OTC access, but with an age restriction, which meant men and women 18 years and older could purchase Plan B at the pharmacy, but only with an ID providing proof of age. The Center for Reproductive Rights (CRR) filed a lawsuit against the FDA over the ridiculousness of placing a scientifically unfounded age restriction on emergency contraception, which eventually led to the lowering of the restriction to 17 years. The FDA was also asked to re-review their rationale for imposing an age restriction in the first place.

Then things got worse. Let’s fast forward to 2011. Continue reading →