Commentary Contraception

Emergency Contraception Should Be Available Over The Counter. And You Can Make That Happen

Kirsten Moore

Last week, the American College of Obstetricians and Gynecologists called for access to emergency contraception over-the-counter. We need to send a clear signal to Secretary Sebelius that women’s reproductive health and medical science should be the driving force behind public policy. Sign the petition being launched by a broad coalition of medical professionals and advocates today urging Secretary Sebelius to revisit the evidence and remove the restrictions.

Last week’s announcement from the esteemed American College of Obstetricians and Gynecologists (ACOG), suggesting it’s time to make oral contraceptives accessible without a prescription, is the perfect way to re-ignite and re-engage public conversation about making emergency contraception (EC) available without restriction. We cannot afford another decade of political delays when it comes to common sense measures to improve women’s health.

Doctors are taking the lead by acknowledging they’ve become unnecessary obstacles between women and their birth control. That is an example politicians need to follow. Medical science, not political ideology, should govern which products are safe and effective. It is clear women of all reproductive ages will be better off when emergency contraception is easily accessible and in their hands.

One year ago next week the Food and Drug Administration was poised to announce that EC had been approved for on-the-shelf access, such that it could appear at your local pharmacy between condoms and pregnancy test kits. But Health and Human Services (HHS) Secretary Kathleen Sebelius stepped in at the last minute and ruled that Plan B One-Step and its generic equivalent must remain behind-the-counter. That decision led to confusion and unnecessary obstacles for women, teens, and couples at the very moment clarity was needed most. For example, we know that:

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  • Doctors and teens have been given misinformation about the age restrictions applied to emergency contraception over the counter (currently 17) or told that teens could not get the product at all (not true). This confusion helps no one.
  • Men have been told by pharmacists in several states around the country that they could not buy EC (not true), presenting obstacles and delays when timing matters.
  • Rape survivors have been denied access to EC by doctors and prison staff.
  • Individuals without government issued identification may have difficulty accessing EC because of the restrictions.

In addition to the practical confusion the Sebelius ruling created, it also set a dangerous policy precedent. Never before has HHS overruled the FDA on a product that had been as thoroughly vetted and researched as EC. To the extent the concern about teens accessing EC was something the Obama Administration didn’t want to have to deal with during the election, they should clearly understand now that the women, young voters, and communities of color who stood in line at the polls did so in part because access to contraception, and the choice it represents in all our lives, is important.

For example, today 82 percent of teen pregnancies are unintended. Seventy percent of  teens in New York City who became pregnant between 2011-2012, dropped out of school. Increased, evidence-based access to EC  could give these teens a second chance to prevent pregnancy and stay in school. But research reveals that because of widespread confusion, 50 percent of teens seeking EC were told the wrong age requirements for buying it. 

The science supporting EC hasn’t changed, but the politics sure have. We need to send a clear signal to Secretary Sebelius that women’s reproductive health and medical science should be the driving force behind public policy. A broad coalition of medical professionals and advocates is launching a petition today to urge Secretary Sebelius to revisit the evidence and remove the restrictions.

Please sign it and share it with your friends. Engage people in conversation about the important issues on social media and help demonstrate the strong consensus for common sense public policy that puts health and science over political ideology. We want to get as many signatures as possible before the one-year anniversary of the Sebelius decision on December 7th, please sign, share, and continue to make your voice heard.

News Contraception

Native American Women Still Don’t Have Access to OTC Emergency Contraception

Martha Kempner

It's been two years since the FDA made certain types of emergency contraception available without a prescription to women of all ages, but Indian Health Service has yet to update its policy.

When the Food and Drug Administration (FDA) in 2013 approved over-the-counter access to certain emergency contraceptive pills without any age restrictions, Indian Health Service (IHS) promised that it would update its policies to make this pregnancy-prevention method available in the pharmacies it runs.

Two years later, the IHS policy remains the same, and a group of U.S. senators last week sent a letter to the secretary of Health and Human Services, Sylvia Mathews Burwell, urging her to look into the matter.

Emergency contraception (EC) is a high dose of hormones that can prevent pregnancy by preventing ovulation if taken within three to five days of unprotected intercourse. The sooner it is taken, the better it works, which is why immediate access without a prescription is so important.

Efforts to win FDA approval for over-the-counter status, however, took the better part of a decade with opponents falsely suggesting that emergency contraception causes abortions (it will not, in fact, affect an established pregnancy) and arguing that making it readily available—especially to teens and young women—will increase promiscuity.

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

The age restriction was dropped to 15 in April 2013. Finally, in June 2013 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.

At the time, a group of lawmakers led by Sen. Barbara Boxer (D-CA) reached out to then U.S. Secretary of Health and Human Services (HHS) Kathleen Sebelius urging her to create a long-term solution that would ensure EC was available over the counter in pharmacies run by the IHS.

Sebelius and her staff replied, promising that they were already working on updates to IHS pharmacy policy. So far, however, no policy has been released.

Boxer’s staff recently conducted a survey of 20 IHS pharmacies and found that EC was not readily available. Some pharmacies did not offer EC at all, others still required a prescription, and others wouldn’t provide it to certain women based on their age.

A similar survey by the Native American Women’s Health Education Resources found that access to EC varied widely at 69 IHS centers.

This is particularly disturbing because Native American women who rely on these health centers often live in rural areas where access to other health care and even pharmacies is limited. As the American Civil Liberties Union (ACLU) points out, “The nearest commercial pharmacy may be hundreds of miles away.”

The ACLU also notes that access to EC is particularly important to Native American women because they face rates of sexual assault that are more than twice as high as other women in this country. EC is often given to sexual assault survivors to reduce the chance that they will become pregnant from their attack.

Last week, to try to spur action, Sens. Boxer, Patty Murray (D-WA), Jon Tester (D-MT), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), and Maria Cantwell (D-WA) wrote another letter to HHS.

“We request that you share the steps your Department has taken towards updating its policy and provide a clear timeline for when that process will be completed,” the letter reads. “Further, we ask that you share with us data from surveys of pharmacies the IHS has undertaken in order to assess access to emergency contraception and the steps that the Department and IHS plan to take to monitor patient access moving forward. We appreciate your consideration of this request.”

“Native American women have waited too long for access to emergency contraception, which is now much more easily available to women across the country,” the ACLU wrote. “The federal government is legally and morally obligated to ensure that these women and communities are not left behind.”

Commentary Contraception

Health Care in Our Hands: Celebrating a Decade of Work to Get Emergency Contraception on Store Shelves

Jessica Arons

August 1 is the one-year anniversary of the Affordable Care Act regulation requiring no cost-coverage of women’s preventive services—including contraception—going into effect. Now we can also celebrate the fact that Plan B One-Step is finally on store shelves across the country.

August 1 has become an important day for women’s health. Not only does it mark the one-year anniversary of the Affordable Care Act regulation requiring no-cost coverage of women’s preventive services—including contraception—going into effect, but now we can also celebrate the fact that Plan B One-Step emergency contraception is finally on store shelves across the country and more accessible than ever before.

Reproductive health, rights, and justice advocates work hard every single day to ensure that women and men are equipped with the tools and information they need to plan pregnancies and determine the course of their own lives. But we seldom take the time to celebrate our victories when they do occur—or to acknowledge and learn from the work that makes victories like August 1 possible.

In the case of emergency contraception (EC), advocates, activists, lawyers, lawmakers, researchers, and health-care providers have been working for more than a decade to make safe and effective back-up birth control available to all—without a prescription, age limits, or delays. Here are some of the highlights from that history:

  • 1995 – Reproductive Health Technologies Project (RHTP) board members Felicia Stewart and Charlotte Ellertson champion an “idea” for a product that would prevent pregnancies after intercourse.

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  • 1997 – Sharon Camp, also an RHTP board member at the time, starts the Women’s Capital Corporation, responsible for the development and commercialization of Plan B emergency contraception.

  • 1999 – James Trussell and Marie Bass launch a hotline and a groundbreaking television and radio campaign to educate the public about EC.

  • 2001 – RHTP, the Center for Reproductive Rights (CRR), and groups including the American Academy of Pediatrics and the Association of Reproductive Health Professionals, submit a Citizen’s Petition to the Food and Drug Administration (FDA).

  • 2003 – Two FDA advisory committees overwhelmingly recommend the sale of Plan B over the counter (OTC) without a prescription.

  • 2004 – Despite its experts’ own recommendations, the FDA denies approval of Plan B OTC.

  • 2005 – CRR files a lawsuit, using the Citizen’s Petition and leaked FDA staff review memos.

  • 2005 – After months of internal and external wrangling, Dr. Susan Wood resigns from the FDA in protest of the Bush administration’s disregard for scientific and clinical evidence.

  • 2005 – National Women’s Liberation protests the FDA’s delay in New York City—a tradition that continues into 2013.

  • 2006 – Thanks to the efforts of Sens. Hillary Rodham Clinton and Patty Murray, the Bush administration is forced to concede OTC access for those 18 and older in order to get the next FDA commissioner confirmed.

  • 2009 – Judge Edward Korman finds that politics had trumped science, orders the age restriction on OTC access to be lowered to 17, and demands that the FDA revisit its decision on EC.

  • 2009 – The National Latina Institute for Reproductive Health publishes a primer on birth control and emergency contraception aimed at Latina women, available in English and Spanish.

  • 2009 – Elizabeth Raymond and colleagues publish research demonstrating that people ages 12 to 17 can use EC safely without assistance from a gatekeeper like a physician or pharmacist.

  • 2011 – In an unprecedented move, Department of Health and Human Services Secretary Kathleen Sebelius overrules the FDA’s decision to grant OTC access to Plan B One-Step, and CRR reopens its lawsuit against the FDA.

  • 2012 – Tina Raine and colleagues publish findings showing that young people can use EC safely in an over-the-counter context.

  • 2012 – The American College of Obstetricians and Gynecologists releases a statement calling for the removal of unnecessary restrictions on EC.

  • 2012 – RHTP and other women’s health advocates keep the pressure on with a nationwide social media campaign calling on the Obama Administration to remove restrictions on EC.

  • 2013 – The American College of Clinical Pharmacy issues its support for the elimination of barriers to EC.

  • 2013 – Finally, after Judge Korman kicks up the heat and rules that the FDA must make EC available without restrictions, and the Department of Justice loses an important part of its appeal, we cry “Victory!” as the headlines read, “Feds Cave on EC Age Restrictions.”

Now, because of those efforts and the efforts of so many others, anyone will be able to walk into a pharmacy or grocery store and grab EC from the store shelf. They won’t have to wait or come back when the pharmacy counter is open. They won’t have to be embarrassed to ask for it in front of others or be shamed about needing to use it. They won’t have to show identification or find someone who has identification to buy it for them. Finally, our health care is in our hands.

But while we can claim “victory,” we cannot claim “mission accomplished.” The FDA granted Teva Pharmaceuticals, the maker of Plan B One-Step, three-year market exclusivity for an over-the-counter EC product for all ages—which means that until April 2016, all generic versions of EC will continue to have cumbersome and unnecessary age restrictions. Additionally, the average price of generic EC is $41, only $7 less than the average cost of $48 for Plan B One-Step. Clearly, there is a lot more work to do.

Even so, on Thursday we celebrate. And we honor the hard work, the vision, the creativity, and the perseverance of those who put EC in women’s hands. To them we say, thank you.

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To help us celebrate, please share photos and videos of EC in your hands. Learn more at http://ecotc.tumblr.com.