Commentary Contraception

Political “Science:” The Ongoing Battle Over Emergency Contraception

Claire Cooper

While Secretary Sebelius’ decision to intervene and block Plan B One-Step’s OTC status was shocking on several fronts, those of us at the Center for Reproductive Rights saw it as “déjà vu all over again.”

This article is published as part of our 2012 Back Up Your Birth Control series.

The influence of politics on science and women’s health was once again on full display late last year. In December 2011, Secretary of Health and Human Services (HHS) Kathleen Sebelius blocked the U.S. Food and Drug Administration’s (FDA) approval of Plan B One-Step’s over-the-counter (OTC) status. It would have been the first time emergency contraception (EC) would be available without a prescription for women of all ages. Instead, it was the first time a HHS secretary overrode the FDA’s decision to approve a medication.

While Secretary Sebelius’ decision to intervene and block Plan B One-Step’s OTC status was shocking on several fronts—given the mounds of scientific evidence proving EC as safe and effective for adolescents and this Administration’s pledge to scientific integrity—those of us at the Center for Reproductive Rights saw it as “déjà vu all over again.”

We’ve been battling the FDA’s politicization of EC for over a decade—trying to hold the FDA accountable in federal court for treating EC differently than any other medication.

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The Center initially filed a Citizen Petition with the FDA in 2001, on behalf of over 70 medical and public health organizations, asking the agency to grant OTC status to all levonorgestrel-based emergency contraception products available at the time.

Because the FDA failed to respond appropriately to both the Citizen Petition and applications from EC drug manufacturers, the Center filed a lawsuit in 2005 asserting that the FDA violated its own procedures, as well as statutory and regulatory mandates, by refusing OTC status for EC.

After the suit was filed, the FDA finally agreed to make Plan B, the leading two-pill EC brand at the time, available to women 18 and older without a prescription. But it remained behind the pharmacy counter and required government-issued identification.

By this time, it had become clear that politics was dictating the FDA’s decisions regarding EC. Four years after our lawsuit was filed, the federal court agreed and ordered the FDA to immediately grant OTC status to Plan B for women age 17 and older, and ordered the agency to reconsider the 2001 Citizen Petition.

It took another two years (and a motion for contempt) before the FDA asserted that it would resolve the issues raised by the Citizen Petition by reviewing a supplemental new drug application (SNDA) for Plan B One-Step, a one-pill EC brand submitted for OTC approval in February 2011. The SNDA sought to switch Plan B One-Step to OTC status for women of all ages. That application’s approval was blocked by Secretary Sebelius in December, even though the FDA had concluded:

“[T]here 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.”

Within a week of Secretary Sebelius’ intervention and on the eve of a hearing scheduled for the Center’s contempt motion against the FDA for once again failing to reconsider the Citizen Petition—the FDA denied the petition.

While U.S. District Judge Edward Korman found the contempt motion moot because the FDA did finally rule on the petition, he said “it seems to me that what we’re going through is a rerun of what happened before,”* because once again it appears that politics is trumping science. He invited the Center to reopen our case and seek additional relief — which is exactly what we did.

On February 8, we reopened the case, adding Secretary Sebelius as a defendant and seeking immediate relief that would allow OTC access for all emergency contraceptives (both the single dose Plan B One-Step and the two-dose generic brands) for women for all ages.

Since then, Judge Korman ordered the FDA to respond to an order to show cause “why the FDA should not be directed to make Plan B available to those persons whom the studies submitted to the FDA demonstrate are capable of understanding when the use of Plan B is appropriate and the instructions for its use.” In other words, why, while the lawsuit is pending, EC should not be made available under the current behind the counter regime to younger teens. A hearing on the order to show cause has been scheduled for April 27.

While the influence of politics on science at the FDA has become increasingly blatant, the regime currently in place for accessing EC has not received the scrutiny it deserves.

OTC status is critical because the pharmacy counter itself is a barrier to access. Women 17 and older may not need a prescription for EC, but they are required to present identification to the pharmacist—posing a serious problem for low-income and minority citizens, who are less likely to possess photo identification.

And it’s not just about identification. Pharmacies may not be open late at night or on weekends, which is problematic, since the effectiveness of EC is contingent on how soon it is taken after unprotected sex or birth control failure. And a new study published in Pediatrics just this week found that nearly one in five U.S. pharmacies gave erroneous  information about EC to 17 year old women, often saying that it was “impossible” for these young women to get the pill.

If EC was granted unrestricted access, it could be sold at stores other than just pharmacies and identification would not be required.

The Center will be back in court next month continuing our battle for broader access to emergency contraception. If our lawsuit is successful, women will be able to back up their birth control regardless of their age, citizenship, or where they live.


*Transcript of December 13, 2011 hearing on motion for contempt before the Honorable Edward R. Korman, E.D.N.Y., at 5.

News Contraception

Native American Women Will Finally Have Improved Access to Emergency Contraception

Martha Kempner

The need for emergency contraception among women who rely on the Indian Health Service is clear. Some Native American women are in rural areas where the next-closest pharmacy may be hundreds of miles away, and they may not have transportation.

The Indian Health Service (IHS) released a long overdue policy last week that will make over-the-counter emergency contraception more accessible for Native American women of all ages.

The policy comes more than two years after the U.S. Food and Drug Administration (FDA) lifted age restrictions on certain emergency contraceptive pills and more than six months after a group of U.S. senators called on the Department of Health and Human Services (HHS) to develop a policy that would ensure access for women who rely on IHS.

A 2014 survey by the Native American Women’s Health Education Resource Center found that access to emergency contraception (EC) varied widely at 69 IHS centers. Some Native American women are in rural areas where the next-closest pharmacy may be hundreds of miles away, and they may not have transportation.

EC is a high dose of the hormones found in birth control pills that can prevent pregnancy by inhibiting ovulation. EC can work if taken up to five days after unprotected sex, but the sooner it is taken, the more effective it can be. That’s why immediate access is important. It is also why advocates for access to this method of birth control fought for almost a decade to make it available without a prescription.

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In July 2009, the FDA approved one of the available versions of EC—marketed as Plan B One-Step— for over-the-counter sale, but limited the sale to women 17 and older. Younger women still needed a prescription.

The FDA in April 2013 lowered the age restriction to 15. A few months later, however, the FDA agreed to comply with a district court ruling and declared that Plan B One-Step would be available without a prescription for “all women of reproductive potential,” regardless of age.

A group of lawmakers led by Sen. Barbara Boxer (D-CA) asked HHS in March for a policy that would ensure that pharmacies run by IHS would follow the new guidelines and make EC easily available, as Rewire reported.

Though HHS promised it was working on the policy in 2013, it released nothing until this week. When Boxer and colleagues readdressed the issue earlier this year, Boxer had conducted a survey of 20 IHS pharmacies and found that some did not offer EC at all, some continued to require a prescription, and others only allowed women of certain ages to access the pills.

The need for EC among women who rely on IHS is clear. As the ACLU has noted, Native Americans face rates of sexual assault that are more than twice as high as other women in this country: One out of three Native American women will be raped during her lifetime. Access to EC is vital for rape survivors.

The policy was finally released last week and is fairly simple. It states, “It is IHS policy the Plan B One-Step emergency contraception pill is easily available through the IHS facilities’ pharmacy, Emergency Department (ED), and in health clinics that are equipped with secure medication storage areas.”

The challenge now is to make sure it is widely implemented.

“The updated policy IHS released today is a long overdue and important step toward ensuring that Native American women have equal access to emergency contraceptive care,” Georgeanne Usova, legislative counsel for the ACLU, said in a statement. “The policy must now be rigorously enforced so that every woman who relies on IHS for her health care can walk into an IHS pharmacy and obtain the services she needs and is legally entitled to.”

News Contraception

New Data: Most Teens Use Contraception the First Time They Have Sex

Martha Kempner

The Centers for Disease Control and Prevention released new data Wednesday that shows fewer teens, especially younger teens, are having sex, and the majority of those who become sexually active use contraception the first time they have sex.

The Centers for Disease Control and Prevention released new data Wednesday that shows fewer teens, especially younger teens, are having sex, and the majority of those who become sexually active use contraception the first time they have sex.

The data also shows that in the past few years, since it has become easier to access, more teens say they have used emergency contraception.

There has been a relatively steady decline in the percentage of teens who have ever had sex over the past 25 years. In 1988, 51 percent of females and 60 percent of males ages 15-to-19 reported having had sex compared to 44 percent of females and 46 percent of males in 2011–2013. Much of this decline reflects the behavior of younger teens who are delaying sex.

Most teenagers are having sex by age 19.

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In 2011–2013, 18 percent of males and 13 percent of females had had sexual intercourse by age 15, 44 percent of males and 43 percent of females had done so by age 17, and, by age 19, 69 percent of males and 68 percent of females had had sex at least once.

The vast majority of these teens (79 percent of females and 84 percent of males) use contraception the first time they have sex. Teens who wait until they are older to have sex are even more likely to use contraception their first time. For example, 93 of female teens who had sex for the first time at 18 or 19 used contraception, compared to 77 percent of female teens who were 17 or younger at first sex.

Almost all male teenagers (99 percent) who had first had sexual intercourse at ages 18 or 19 used a method of contraception, compared with 82 percent of those who were 17 and under at first sex.

Using contraception at first sex is an important indicator of future use. The data shows that young women who did not use a method of contraception at first sexual intercourse were twice as likely to become teen mothers as those who used a method.

Not surprisingly, the most common form of contraception used at first intercourse was the condom. Condoms are inexpensive and easily accessible. And, they are the only method of contraception that also protects against sexually transmitted diseases. Condom use is a nearly universal experience—97 percent of sexually active teen girls said they had used a condom.

The next most popular method was withdrawal, which had been used by 60 percent of sexually active teen girls, followed by the pill at 54 percent. Fifteen percent of sexually active girls had used Depo-Provera (sometimes called the contraceptive shot), 5 percent had used the ring, 3 percent had used intrauterine devices (IUDs), 2 percent had used the patch, and 2 percent had used the contraceptive implant.

One of the more interesting findings was the increased use of emergency contraception. In 2002, 8 percent of female teenagers who had ever had sexual intercourse said they had used emergency contraception, compared to 22 percent in 2011–2013. This 14 percent increase over a decade likely reflects increased access to this important method of preventing pregnancy.

Emergency contraception (EC) is a high dose of hormones, similar to those in birth control pills, that inhibit ovulation. EC can prevent pregnancy if taken within three to five days of unprotected intercourse. The sooner it is taken, the better it works, which is why advocates wanted this drug to be available without a prescription.

Efforts to win FDA approval for over-the-counter status took the better part of a decade. While advocates argued for easy access, opponents suggested that making it more readily available would increase promiscuity, especially in teens and young women.

In 2009, one of the available versions of EC—marketed as Plan B One-Step—was approved for over-the-counter sale, but only to women 17 and older. Younger women still needed a prescription. In April 2013, the age restriction was dropped to women 15 and older. In June of that year, the FDA—complying with a district court ruling—declared that Plan B One-Step would be available without a prescription for “all women of reproductive potential,” regardless of age.

The new data can’t show definitively that OTC access is the reason that EC use is up among teens, but many experts believe it’s a factor. Of course, experts note that rising use of EC is a bit of a double-edged sword. While it has likely helped prevent unintended pregnancy, it is also a sign that some young people continue to have unprotected sex.