Court Orders FDA to Make Emergency Contraception Available Over-the-Counter for All Ages


VIDEO: The Science of ‘Plan B’ – Emergency Contraception

What happens when the condom breaks? Find out what’s behind “Plan B” – otherwise known as emergency contraception.

In a long-awaited decision released early this morning, U.S. District Court Judge Edward Korman ordered the U.S. Food and Drug Administration (FDA) to make emergency contraception available over-the-counter to women of all ages, marking a major win for public health and women’s rights in a year that has seen science otherwise buried under an avalanche of anti-choice politics. In his decision, Judge Korman orders the FDA to make levonorgestrel-based emergency contraception available over-the-counter without an age or point-of-sale restriction.

Today’s order was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the agency seeking to expand over-the-counter access to all brands of the morning-after pill, including Plan B One-Step and Next Choice, to women of all ages.

The court has ordered the FDA to make emergency contraception available without a prescription and without point-of-sale or age restrictions within 30 days, with the option to limit the change to only Plan B One-Step if the agency “actually believes there is any significant difference between the one- and two-pill products” and to require new labeling if necessary.

Women’s rights groups are celebrating the decision.

“Today science has finally prevailed over politics,” said Nancy Northup, president and CEO of CRR, which brought this and other lawsuits. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods. “Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception. It’s a true victory for all women, especially young women, women without government-issued identification, and those who live in areas with limited pharmacy hours,” she added.

Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project, which has been a leading advocate for emergency contraception, concurred: “Today we celebrate a long overdue victory for all women. Our decade long struggle is finally over. Emergency contraception will now sit on store shelves allowing timely access to this important product used to prevent unintended pregnancy. We urge Secretary Sebelius and the FDA to move swiftly to put emergency contraception on store shelves and into the hands of women and couples who need it.”

In a statement, the National Latina Institute for Reproductive Health applauded the ruling:

For Latinas in particular, expanded access to emergency contraception is critical for making the best decisions for our families and ourselves. For too long, this important backup birth control method has been kept behind the counter and out of reach. Immigrant women and new Americans of all ages have been hit particularly hard, since they are less likely to have government identification. This decision removes one barrier for Latinas who need contraception—though others, like poverty, discrimination, language and immigration status, remain.

This victory came after a long and unnecessarily difficult battle that was marred by politics, irrespective of the political party in charge. (See timeline following article.)

The FDA first approved emergency contraception (EC) for prescription use in 1999. Subsequently, study after study showed the safety of EC for women of all ages seeking to prevent an unplanned pregnancy after unprotected sex or contraceptive failure. In 2003, the first application was made to the FDA to approve EC for over-the-counter (OTC) sales. And thus began a long game of politics that has spanned both the Bush and Obama administrations. First, the Bush administration refused to act to make EC available OTC, resulting in the first successful lawsuit by advocates to ensure that science, rather than politics, governed women’s access to this method of basic preventive reproductive health care. EC was first made available OTC for women ages 18 and older, though the science clearly affirmed its safety for younger women.

After years of advocacy and further scientific proof of efficacy and safety, it seemed that finally EC would be made available over the counter for all women. However, in a deeply controversial move in December 2011, Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), overruled the decision by FDA Commissioner Margaret Hamburg to approve over-the-counter sales of Plan B One-Step. President Obama publicly supported Sebelius’ decision, in what was widely seen as a political move. Public health, medical, and legal groups went into overdrive, conducting a wide-ranging public education campaign, launching a citizen’s petition, releasing statements in support of EC OTC, and filing the lawsuit that led to today’s decision, in which Judge Korman called Sebelius’s actions “politically motivated, scientifically unjustified, and contrary to agency precedent.” Said Judge Korman, “The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable.”

“It’s shameful it has taken over a decade and a federal court order for the U.S. government to implement in policy what studies and experience have proven time and time again—emergency contraception is safe and effective and should be available for women of all ages,” said Janet Crepps, senior counsel for CRR.

Currently, EC is available to women ages 17 and older without a prescription; young women under 17 are required to obtain a prescription from a physician. Even for women 17 and older, however, the medication is available only at health clinics or pharmacies, upon request and with adequate identification.

This unique and unnecessary dual scheme, notes CRR, has impeded access even for women who are allowed to obtain the drug without a prescription, as evidenced by several studies, including one published in the journal Pediatrics earlier this year. A total of 943 pharmacies in five major cities were contacted twice by researchers at Boston University—once the researchers posed as a 17-year-olds and another time as physicians. The study found that there misinformation was common regarding who can take EC and at what age it is available without a prescription, creating barriers to timely access. According to the research, nearly 20 percent of the drugstores contacted denied the “17-year-olds” access to the pill.

With the court’s ruling today, drug companies can now apply to make EC available to women of all ages and at stores other than just pharmacies—eliminating human error in determining who can and cannot purchase the medication.

#####

CRR Emergency Contraception Case Timeline

July 28, 1999: The U.S. Food and Drug Administration (FDA) approves Plan B, an emergency contraceptive medication, for prescription use.

February 14, 2001: The Center for Reproductive Rights files a Citizen Petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available without a prescription or over-the-counter (OTC).

April 21, 2003: Women’s Capital Corporation, the manufacturer of Plan B, files an application with the FDA to make Plan B available OTC.

Late December 2003/January 2004: After a panel of FDA experts recommends approval of the Plan B application, Dr. Steven Galson, the head of the office responsible for making the final decision, informs his staff that the regular procedures won’t be followed this time, and that that office won’t make the final decision. (Jenkins deposition)

December 2003 to Jan 17, 2004: Galson confesses to a co-worker that he has to reject the Plan B application because he’s afraid he’ll lose his job. (Jenkins deposition) Dr. Janet Woodcock, the second in command at the FDA, tells a colleague that the agency first has to reject the application, then approve the drug later with an age restriction in order to “appease the administration’s constituents.” (Houn deposition)

May 6, 2004: The FDA denies the manufacturer application and suggests Barr, the drug’s new manufacturer, amend the application to request an OTC switch only for women 16 and older. (Barr revises the application; the FDA schedules a decision for January.)

January 21, 2005: After the FDA fails to meet its deadline, the Center files a lawsuit against the agency for ignoring science and holding Plan B to a different standard than other drugs.

August 26, 2005: The FDA misses its second deadline to rule on Barr’s application. In a peculiar move, the agency requests the public provide input over an indefinite period of time on how to dispense the drug.

February 24, 2006: The Center is cleared to depose high-level FDA officials. The New York magistrate judge cites strong showing of “bad faith and improper behavior” by the FDA.

June 9, 2006: FDA denies Citizen Petition for the first time.

August 24, 2006: The FDA agrees to make Plan B available without a prescription, but only to women 18 and older who can provide government issued identification. The FDA also requires that Plan B be sold behind pharmacy counters.

March 30, 2007: Center files for summary judgment in the case, arguing that the undisputed facts found in evidence gathered through discovery make it unnecessary for the court to hold a trial, and that the court should order the FDA to make Plan B available without a prescription to women of all ages.

March 23, 2009: Court orders the FDA to approve Plan B for those 17 and older without a prescription and to reconsider the Citizen Petition and all age and other restrictions on OTC access.

July 10, 2009: The FDA approves Plan B OTC for those 17 and older. The FDA also approves Plan B One-Step, which is a product that consists of the same drug as Plan B but in one pill rather than two. Both Plan B and Plan B One Step are OTC for those 17 and older and prescription-only for those 16 and younger.

August 28, 2009: The FDA approves Next Choice, a generic version of Plan B, under the same regime: OTC for those 17 and older and prescription-only for those 16 and younger.

November 16, 2010: The Center files a motion for contempt of court against the FDA for failing to reconsider the Citizen Petition and the current restrictions on OTC access to Plan B.

December 1, 2010: After receiving FDA approval for prescription-only use, Watson Pharmaceuticals launches ella, another form of emergency contraception (ulipristal acetate).

February 7, 2011: Teva Pharmaceuticals, the manufacturer of Plan B One-Step, files a supplemental new drug application (sNDA) with the FDA so that the drug will be available OTC for women of all ages.

Dec. 7, 2011: HHS Secretary Sebelius takes an unprecedented step to block FDA Commissioner Hamburg’s approval of Plan B One-Step manufacturer’s application for OTC status, which included additional data that confirmed its safety for all-ages use. The next day, President Obama publicly supports Sebelius’s decision, “as a father of two daughters.”

Dec. 12, 2011: On the eve of a court hearing on the Center’s motion for contempt, the FDA denies the Citizen Petition for a second time based on a lack of teen-specific data for the two-dose medication, despite the volume of data before the FDA on two-pill emergency contraception products, which data for one pill products of emergency contraception confirmed.

Dec. 13, 2011: Judge denies contempt motion because FDA had ruled on the Citizen Petition the night before, but invites CRR to reopen the case. Judge notes striking similarities between recent actions and 2005-2009.

Feb. 8, 2012: CRR reopens its case, filing a motion for preliminary injunction and summary judgment for immediate relief that would allow OTC access for all levonorgestrel-based emergency contraceptives (both one and two pill versions) without any age or point of sale restrictions. CRR also adds Sebelius as a defendant and supplements the complaint.

February 16, 2012: Judge Korman issues Order to Show Cause to Defendants “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 due.”

March 9, 2012: Teva Women’s Health, Inc., the manufacturer of Plan B One-Step, files a motion to intervene in the case.

April 27, 2012: Hearing held on Court Order to Show Cause and Motion of Teva Women’s Health to Intervene.

April 5, 2013: Judge Korman orders FDA to make levonorgestrel-based emergency contraception available over the counter without age or point of sale restriction.

Like this story? Your $10 tax-deductible contribution helps support our research, reporting, and analysis.

To schedule an interview with contact director of communications Rachel Perrone at rachel@rhrealitycheck.org.

Follow Jodi Jacobson on twitter: @jljacobson

  • Rdzkz

    If you do not want or need this, then do not buy any. Leave it alone. If you are a woman, and do not have/not planning to have 13-17 pregnancies during your lifetime — then support this; if you are a man and not planning ANY of your women to have 13–17 pregnancies to pay and support during your lifetime, then support this! If you have 13-17 and more children that you are directly supporting –with no government assistance — from birth to a productive adulthood, then you can disagree with this.

    • pasha19

      While I agree with the sentiment, I have to tell you that your use of the phrase “your women” is a little discomfiting.

    • funkzillabot

      ….and if you are a man who has not placed a ring on YOUR WOMEN’s finger. Then you DON’T get a say or an opinion in this subject at all. Mind your business.

  • Bruce Sikkema

    Buy your plan “B” ahead of time and freeze it. It should be effective for 40 to 80 years. Hormonal birth control legally has a shelf life in the U.S. of 1 year, but the same medication in Canada has a shelf life of 5 years, and the shelf life doubles for every 20 degrees F colder that it is. Talk to your chemestry teacher.

    • Lindsay

      Speak to any pharmaceutics professor at your local pharmacy school and he/she will disagree. Shelf life of pharmaceutical products is MUCH more complicated than shelf life of simple chemistry reagents. In fact, keeping tablets for longer than their approved shelf life, frozen or not, can result in changes in the excipient materials (the materials used to make the tablets, not the active drug) that can cause the drug’s administration and absorption in the body to be slower than intended. This means your emergency birth control won’t actually prevent the pregnancy! Also, just because Canada has a shelf life of 5 years doesn’t mean the drug distributed in the U.S. has the same shelf life. Canada has different regulations regarding manufacturing practices, so even if it’s from the same company, the manufacturing process can differ greatly!

  • mvpel

    Hopefully cashiers in stores which sell this will be trained on child sexual abuse mandatory reporting laws. Some states impose criminal penalties on failure to report.

    • http://twitter.com/JenGStarr Jennifer Starr

      What does this have to do with anything? And exactly how is the cashier supposed to know that a child is being abused? Just because the child is a minor does not mean they’re having sex with an adult. It’s more likely to be another minor.

  • Bruce Sikkema

    Lindsay:

    Ouch! Point quite possibly well taken. However, it is still better to have purchased it ah

  • Bruce Sikkema

    Lindsay:

    Ouch! Point quite possibly well taken. However, it is still better to have purchased it ahead of time, and if your Plan “B” doesn’t keep you un-pregnant, there are still many other options open to you, and you should have plenty of time to use them. I have been quite careful this way, and I have never made anyone pregnant.

  • jen

    Women have been told they can ‘obtain EC OTC’ before (only to be standing at counter being told “No!”)… I don’t see anything specifically stating any of the barriers have been removed..? Is it still ‘only’ in cases of sexual assault? Do the stores still have the right to ‘morally object’? Will we be expected to pay cash, or will we be able to use our insurance coverage (that says its covered??)

    • jen

      How about in the ER? Who decides what constitutes an emergency…? The patient requesting it, or the on-call physician?

  • Jenny Hanniver

    HURRAH for a truly MORAL decision! I’m 20 years past menopause, but I’m glad for you, sisters!

  • http://www.facebook.com/people/Margaret-Whitestone/100001682409207 Margaret Whitestone

    It’s about time.

  • Jac

    I don’t support this bc its abortion. Call me ‘narrow minded’ but animals are treated better than human babies. I have had an unwanted pregnancy, but I didn’t take the easy out. If you get yourself in a situation to get pregnant, that’s your fault, not the babies. If you can’t take care of a baby at this time in your life, there are plenty of people ready and willing to give anything for a child.

    • Jodi Jacobson

      Except it doesn’t cause abortion. That is a lie you have been fed and apparently haven’t checked out. As the science we have cited here and elsewhere shows, EC prevents ovulation and affects sperm motility, and therefore prevents fertilization. You can not have an abortion if you are not pregnant.

    • http://twitter.com/JenGStarr Jennifer Starr

      No, it is not abortion, not in any sense of the word.

    • http://www.facebook.com/ella.warnock.7 Ella Warnock

      1. No, it’s not abortion. It’s scare-mongering and you’ve bought into the lie hook, line, and sinker.

      2. You made your choice to have a child. If you willingly hand over to government the decision to ban abortion, you must might eventually end up with a government that FORCES abortion. You’d better be glad you were able to make that choice freely. As far as “easy,” well easy is in the eye of the beholder, isn’t it?

      3. Women with unwanted pregnancies are not obligated to provide infants for those who can’t make their own.

    • cjvg

      I guess nobody told you that careless irresponsible sluts like you should have abortions , you have no right to force a decent responsible woman to follow your example!

      Yes we know that misery loves company, however it is not acceptable to force another woman into the same irresponsible selfish choice you made just to make you feel better about your choice!

      See how ridiculous your slut shaming, take your punishment for having sex tactics are, not so pleasant when someone with a pro-choice opinion applies them to you, now is it?!

    • http://www.facebook.com/Feral.9.Hex Carla Clark

      Humans ARE animals. No babies are involved in abortion, unless you wanna talk Lina Medina. Fetuses of other animals are treated the SAME as human fetuses.

      Why are you equating a fetus with a born animal? The whole fucking point is that NO ONE gets the right to co-opt someone else’ organs against their wishes, not even to save their life. So, PLEASE, tell me how that comparison was in ANY way equitable. Oh, right, I forgot, you’re an anti-choicer, one of those who lacks the skill of critical thinking.

      So, are you saying that a woman who consented to sex, initially, has no right to use lethal force, because it’s her fault she consented to sex and did not revoke that consent BEFORE the other entered a fugue state?

      If yes, you are sick. If no, you are a hypocrite. In my books there
      isn’t much worse than a hypocrite. It’s really sad, though, that antis
      like you haven’t learned their lesson and realized just how repugnant to
      ACTUALLY moral human beings their position is.

      Are you saying that a rapist is only killed because they are at fault, rather than because they are violating someone’s bodily autonomy? Then you don’t understand that rape does NOT require intent or guilt to occur. Then you don’t understand that the use of self-defense is NOT determined by who is at fault (OBVIOUSLY).

      Abortion is the easy way out? With people like YOU, who stigmatize, harass, shame, threaten, kill and MURDER them for it? Please, you don’t know what the easy out IS.

  • funkzillabot

    Excellent. A small win for reason and normality, against the morons who can’t mind their own business.

  • xve298

    Yeah but who can afford it? These cost 40-70 dollars!