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04.05.13 - (PRESS RELEASE) In a landmark decision, a federal judge has ordered the U.S. Food and Drug Administration to lift longstanding restrictions that impede and delay women's access to emergency contraception.
U.S. District Court Judge Edward Korman has ordered the FDA to make levonorgestrel-based emergency contraception available over-the-counter without age or point of sale restriction-citing the actions by the U.S. Department of Health and Human Services Secretary Kathleen Sebelius as "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."
Today's order was issued in response to the Center for Reproductive Rights' renewed lawsuit against the agency seeking to expand over-the counter access to all brands of the morning-after pill, such as Plan B One-Step and Next Choice, to women of all ages.
"Today science has finally prevailed over politics," said Nancy Northup, president and CEO for the Center for Reproductive Rights. "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.
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.
"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 the Center.
Currently, emergency contraceptives (EC) are available to women 17 and older without a prescription, with young women under 17 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 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 posing as a 17-year-old and another time as a physician. The study found that there was misinformation regarding who can take EC, and at what age it is available without a prescription was common-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.
The Center filed Tummino v. Hamburg along with Andrea Costello of the Partnership for Civil Justice Fund and Kirsten Clanton of Southern Legal Counsel on behalf of grassroots feminist activists with National Women's Liberation and 15-year-old Anaya Kelly. The Center also represents the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and parents who seek over-the-counter access for their daughters in the case.
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.