Background information on the Morning-After Pill Litigation

Background information on the Morning-After Pill Litigation

The PCJF represents grassroots feminist activists with National Women’s Liberation (NWL) and 15-year-old Anaya Kelly in a lawsuit against the Food and Drug Administration (FDA) and Health and Human Services (HHS) to remove all restrictions on over-the-counter access to the Morning-After Pill (also known by trade name Plan B One-Step and as “emergency contraception”) for all women and girls in the United States.

The lawsuit seeks to ensure that the Morning-After Pill is granted true over-the-counter status and made widely available to women and girls of all ages.

For the first time in U.S. history, in 2011, the Obama Administration’s HHS overruled a decision by the FDA that would have made the Morning-After Pill available to all persons over-the- counter and without restrictions. Years of litigation combined with grassroots feminist political organizing had finally overturned the FDA’s efforts to withhold and restrict this critical contraception, but the Obama Administration made a political decision to continue to restrict access to this safe and effective form of birth control.

Background Information on the Litigation

The lawsuit, now spanning both Republican and Democratic administrations, was originally filed on January 21, 2005, after years of unexplained delay by the FDA to respond to requests by feminist, women’s health and reproductive rights organizations – including through a Citizen Petition – to switch emergency contraception drugs from prescription-only to over-the-counter.

The litigation uncovered evidence that the Bush Administration pressured FDA scientists to enact an age limit on the pill for political reasons. Testimony from high-level FDA officials and documents obtained in discovery showed the agency’s decision was not based on science but, rather, due to improper political influence. While the lawsuit was pending, the FDA finally made a decision that it would only allow women 18 or older, who could produce government-issued ID to prove age, to get the Morning-After Pill from behind a pharmacy drug counter. All along, the FDA’s decisions were against the recommendations of its own scientific review staff and women’s experience that this is a safe and effective form of birth control.

On March 23, 2009, the Court ruled that the FDA “acted in bad faith and in response to political pressure,” “departed in significant ways from the agency’s normal procedures,” and engaged in “repeated and unreasonable delays.”  The Court ordered the FDA to make Plan B available over-the-counter to 17 year olds (the drug was previously limited to women ages 18 and up). The Court also ruled that the FDA had to reconsider whether to approve the Citizen Petition asking for unrestricted over-the-counter status for women and girls of all ages.

In November 2010, Plaintiffs filed a motion for contempt against the FDA for continually failing to follow the Court’s March 2009 Order and rule on the Citizen Petition.

In February 2011, the manufacturer of Plan B One-Step (a one-pill product), filed an application with the FDA requesting over-the-counter access without age restrictions. In December 2011, the FDA finally decided to eliminate the unnecessary age restriction for Plan B One-Step, but in an unprecedented move, HHS blocked the change with President Obama’s support. The FDA then denied the Citizen’s Petition for reasons similar to its first denial, which the court had found were arbitrary and capricious, the result of improper political influence and significant departures from normal agency procedures.

On February 8, 2012, Plaintiffs moved to re-open the case, add HHS Secretary Kathleen Sebelius as a Defendant and to supplement the Complaint. Plaintiffs also filed a Motion for a Preliminary Injunction and Summary Judgment seeking immediate relief that would allow over-the-counter access for all levonogestrel-based emergency contraception products (both one and two-pill versions) with no restrictions on age or how they are sold. The Court issued an Order to Show Cause asking the FDA to explain why it should not 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 July 2012, the Defendants filed a cross-motion for Summary Judgment. These motions are pending.

Andrea Costello is PCJF lead counsel in the case. She has over 12 years of experience as a civil rights litigator and movement attorney working on issues including reproductive justice and defending the right to dissent. She has been a community organizer for women’s rights and social justice for over 20 years. Prior to law school, she worked at the Gainesville Women’s Health Center, the first feminist abortion clinic founded in the South after Roe v. Wade.

This case is in cooperation with the Center for Reproductive Rights and Kirsten Clanton of Southern Legal Counsel. Plaintiffs include: the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and a number of young women and their parents.

Why is the Morning-After Pill So Important to Women’s Freedom?

Restricting the Morning-After Pill to females ages 17 and older makes it physically inaccessible to everyone because it is kept “behind-the-counter” at pharmacies and an ID must be shown to buy it. The Morning-After Pill is already available without a prescription in at least 63 other countries, including the United Kingdom, France, Denmark and Ghana. 

National Women’s Liberation has led the grassroots fight for unrestricted access to the Morning-After Pill in the United States.  From sitting in at the FDAdemonstrating in front of HHSorganizing speakouts and filing a lawsuit against the agencies, NWL members have been at the forefront of this struggle, winning a huge victory in 2006 when the FDA decided to eliminate the prescription requirement for women ages 18 and up, and another victory in the Tummino case in 2009 when the Judge ordered the FDA to also eliminate the prescription requirement for girls aged 17. 

Feminist organizing – in the streets and in the courts – has forced the FDA to grant over-the-counter access to the Morning-After Pill for women ages 17 and up. The position of NWL has been uncompromising in this fight: any female old enough to get pregnant is old enough to decide that she doesn’t want to be pregnant. For more information about NWL and how to join the campaign for unrestricted access to the Morning-After Pill, go to: