TIMELINE-Key dates in legal battle over 'morning-after' pill
NEW YORK, April 5
NEW YORK, April 5 (Reuters) - A federal judge in Brooklyn, New York, on Friday directed the U.S. Food and Drug Administration to make emergency contraception available over-the-counter to women of all ages.
The ruling is the result of a more than decade-long legal fight by reproductive-rights and public-health groups to remove barriers to the drug. Here are some key dates in that fight:
1999: Teva Pharmaceutical Industries Ltd receives FDA approval to market Plan B, the first emergency contraceptive drug for prescription-only use in the United States.
2001: Center for Reproductive Rights and more than 70 medical and public-health groups file a citizen petition seeking to strike restrictions on Plan B.
2005: Reproductive-rights groups file lawsuit in Brooklyn federal court seeking to force FDA to respond to their petition.
2006: FDA denies the groups' petition. However, several months later, the FDA said Plan B could be sold without a prescription to women 18 years and older who present government-issued identification at pharmacy counters.
2009: U.S. District Judge Edward Korman in Brooklyn rules that FDA acted in "bad faith" in denying the petition, orders emergency contraceptives be made available to women 17 and older, and directs FDA to reconsider whether the age and access restrictions can be lowered even further.
February 2011: Teva files a petition to make Plan B One-Step, a one-pill version of Plan B, available over-the-counter without age or access restrictions.
December 7, 2011: FDA rejects Teva's petition. The rejection is accompanied by two statements: one from FDA Commissioner Margaret Hamburg, saying there is scientific evidence to support the drug's safe use in younger girls. The other, from HHS Secretary Kathleen Sebelius, says there is not.
December 12, 2011: FDA rejects the citizen petition. They say that since Teva's petition was not accepted, it could not justify lower restrictions for two-pill versions of the drug, when the one-pill version was not proven sufficiently safe.
February 2012: Reproductive-rights groups re-open their lawsuit and add Sebelius as a defendant. Korman orders the defendants to show why the FDA shouldn't be directed to revise age and access restrictions on Plan B and other emergency contraception.
April 5, 2013: Korman directs FDA to grant the citizen petition and make emergency contraception available over-the-counter to women of all ages.
Sources: Reuters, court filings (Reporting by Jessica Dye; editing by Andrew Hay)
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