The Center for Reproductive Rights has engaged in a decade long battle with the U.S. Food and Drug Administration (FDA) to make emergency contraception available without restrictions for all women. From a Citizen Petition filed in 2001 to a suit in federal court, the Center has been relentless in asking the FDA to approve Plan B for over-the-counter use. The timeline below follows the journey from our first legal action in 2001 through the present.
Timeline of Events
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: The 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: The 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 on Court Order to Show Cause and Motion of Teva Women’s Health to Intervene is scheduled.
April 5, 2013: Judge Korman orders FDA to make levonorgestrel-based emergency contraception available over the counter without age or point of sale restriction within 30 days.
April 30, 2013: FDA approves Teva's application to make Plan B One Step available OTC to women 15 years and older.
May 1, 2013: Defendants file a Notice of Appeal with the Second Circuit Court of Appeals and a Motion for Stay with Judge Korman.
May 10, 2013: Judge Korman denies the Defendants' Motion for Stay.
May 13, 2013: Defendants file Motion for Stay with the Second Circuit.
June 5, 2013: 2nd Circuit partially denies the stay, holding that the Government must make two-pill, but not one-pill, products available immediately.
June 10, 2013: FDA grants Citizen Petition, promising to make Plan B One Step available OTC without age or point-of-sale restrictions. The Defendants indicate that they will withdraw their appeal.
June 12, 2013: Judge Korman approves the FDA's plan to make Plan B One Step available OTC without age or point-of-sale restrictions as satisfying the requirements of his April 5 order.
June 20, 2013: The FDA approves Teva's application to make Plan B One Step available over the counter, thus coming into compliance with the order of April 5. Plan B One Step becomes available in pharmacies and grocery stores, including those without a pharmacy on-site.
July 23, 2013: Defendants dismiss their appeal of Judge Korman's April 5 decision to the Second Circuit.