Timeline: The Battle For Plan B
2013-06-12
By Alexandra Sifferlin
On Monday, the Obama administration announced it is ending its fight to keep age restrictions on the morning-after pill. The Department of Justice will no longer appeal the ruling by Judge Edward Korman of the District Court of Eastern New York that overturned Health and Human Services (HHS) Secretary Kathleen Sebelius’ decision to keep the age limit of 17 on obtaining Plan B without a prescription.
Instead, it plans to move forward on making the morning-after pill available to girls of all ages, over-the-counter and without a prescription.
For over a decade, reproductive rights advocates, politicians, the FDA, and Plan B manufacturers have clashed in a back and forth of regulation and restriction with advocates for the pill pushing for the greater availability and opponents arguing for limiting access for girls considered by some to be too young to understand the risks.
Here is a timeline of the key legal moments in the battle to get Plan B over-the-counter:
1999: The FDA approves Teva Pharmaceutical Industries Ltd to market the emergency contraceptive drug levonorgestrel as Plan B, and offer it as a prescription-only drug. At the time, Plan B was two tablets. The first tablet was taken within 72 hours of unprotected sex and another was taken 12 hours later.
2001: The Center for Reproductive Rights and over 70 other public-health groups file a citizen petition to make Plan B available over-the-counter and without a prescription.
2003: Teva files an FDA application to make the drug available over-the-counter. This spurred political conflict over wether the drug should be easily accessible to minors.
2005: The Center for Reproductive Rights files a lawsuit in Brooklyn federal court to force the FDA to respond to their petition. They argue the FDA is holding Plan B to stricter standards compared to other drugs and not embracing evidence.
2006: The FDA denies the Center for Reproductive Rights’ citizen petition. But a few months later, the federal agency gives the OK for Plan B to be sold without a prescription to women ages 18 years and older. Minors still need a prescription.
2009: U.S. District Judge Edward Korman in Brooklyn rules that FDA acted without good faith in denying the petition, and orders morning-after drugs to be made available to women 17 and older. Korman says the FDA should think about lowering the age and access restrictions.
The FDA also approves Plan B One-Step, which allows women to take only one pill instead of two pills.
August 28, 2009: The FDA approves Next Choice, a generic version of Plan B. Next Choice is also available over-the-counter for women ages 17 and older and with a prescription for anyone younger.
February 2011: Teva files an application with the FDA to move Plan B from “dual label” status–which requires it to be sold under over-the-counter and prescription-drug regulations– to a full over-the-counter status without age limits. This would make the drug easier to buy off the shelves, like condoms and other medications. The FDA has until Dec. 7 to make a decision.
December 7, 2011: After reviewing Teva’s application and available research, the FDA‘s Center for Drug Evaluation and Research (CDER) determined the drug was safe and effective for girls of all ages, and concluded that adolescents were capable of using and understanding the risks of Plan B without their doctor’s aid. In a statement, FDA commissioner Margaret Hamburg says there is adequate evidence that the morning-after pill is for “all females of child-bearing potential.”
But, the FDA ultimately rejects Teva’s application after receiving a memorandum from Sebelius that overruled the recommendation, saying TEVA failed to provide research showing that young girls could use the drug safely. President Obama, backed up Sebelius’ decision, saying, “As I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way,” according to the New York Times.
December 12, 2011: The FDA dismisses the Center for Reproductive Rights’ citizen petition again [PDF], stating that there is still not enough research on whether users comprehend labeling and usage for the two-dose Plan B version.
February 2012: The Center for Reproductive Rights re-opens their lawsuit against the FDA for its restrictions against morning-after drugs. This time, they also add Sebelius as a defendant for her overruling on the FDA’s decision to make Plan B available over-the-counter in 2011.
April 5, 2013: Judge Korman overturns Sebelius’ decision to have age limits for getting Plan B without a prescription. Korman says the ruling was made in “bad faith and improper political influence.” Writing in his decision he states that, “it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.”
April 30, 2013: FDA announces that the Plan B morning-after pill will move out from behind the counter and be available for girls ages 15 and older without a prescription. The FDA says the new approval was independent of Judge Korman’s April 5 order, and was for an already pending application from Teva that requested its product be made available over-the-counter for women aged 15 or older. A spokesperson for the HHS told TIME that Commissioner Hamburg briefed Sebelius about the review process and the amended Teva application, and Sebelius felt the new decision met her concerns.
May 1, 2013: The Obama administration announces it is appealing Koman’s order to lift all age limits on buying Plan B without a prescription.
June 5, 2013: The 2nd U.S. Circuit Court of Appeals in Manhattan permits girls of all ages to purchase generic versions of morning-after drugs without a prescription.
June 10, 2013: The Department of Justice announces it will no longer seek an appeal. The federal group alerted Judge Korman that it plans to submit a compliance plan and if the judge he approves it, the Department of Justice will drop its appeal.