WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Wednesday approved the wider sale of Barr Pharmaceuticals Inc’s morning-after contraceptive pill without a prescription to 17-year-olds.
The drug, called Plan B, helps prevent pregnancy if taken within 72 hours of sexual intercourse. Barr was recently acquired by Teva Pharmaceutical Industries Ltd.
Following are some key dates in the drug’s U.S. history:
*July 28, 1999 - The FDA approves Plan B as a prescription drug to prevent pregnancy.
*April 21, 2003 - Women’s Capital Corp, which later sells Plan B to Barr, submits an application to the FDA seeking approval to sell the drug without a prescription, or “over the counter” to consumers of all ages.
*December 16, 2003 - An FDA panel of outside advisers overwhelmingly recommends the agency approve Plan B for nonprescription use, voting 23-4.
*May 6, 2004 - The FDA rejects wider sales of Plan B, citing concerns about use of the product by young girls. The agency suggests Barr provide data showing young girls can use the pill safely, or seek permission to sell the product without a prescription only to females age 16 and older.
*July 22, 2004 - Barr resubmits its application, this time asking to sell the drug over the counter to females 16 and older.
*April 6, 2005 - Democratic Sens. Hillary Clinton and Patty Murray say they will block a Senate vote on U.S. President George W. Bush’s nominee to head the FDA, acting FDA Commissioner Lester Crawford, until a decision is made whether to approve nonprescription sales of Plan B.
*January 21, 2005 - The Center for Reproductive Rights sues the FDA for failing to make a decision on over-the-counter access to Plan B.
*July 15, 2005 - Clinton and Murray drop their objections to a Senate vote on Crawford after receiving assurances the FDA will act on Plan B by September 1.
*August 26, 2005 - Crawford indefinitely delays action on Barr’s revised application, saying he needs public input on legal issues surrounding how to regulate a drug that would be available both with and without a prescription. FDA says Plan B is safe and effective when used by females age 17 and older.
*August 31, 2005 - Susan Wood, FDA assistant commissioner for women’s health, resigns to protest the agency’s failure to approve over-the-counter sales of Plan B.
*September 23, 2005 - Crawford resigns from the FDA.
*March 15, 2006 - Bush picks acting FDA Commissioner Andrew von Eschenbach to hold the job permanently. Clinton and Murray say they will block a Senate vote on von Eschenbach until the agency decides whether to ease access to Plan B.
*July 31, 2006 - In a letter to Barr one day ahead of his Senate confirmation hearing, von Eschenbach says he is willing to consider nonprescription sales for those 18 and older as long as the drug is kept behind the pharmacy counter.
*August 18, 2006 - Barr and the FDA say the company has refiled its application but declined to give details.
*August 24, 2006 - The FDA approves sales of Plan B from behind pharmacy counters to consumers aged 18 and older without a prescription. Those 17 and younger still need a prescription.
*March 23, 2009 - The U.S. District Court for the Eastern District of New York rules that the FDA allowed politics to interfere with its usual decision-making process in reviewing Plan B. In siding with the Center for Reproductive Rights, it orders the FDA to allow nonprescription sales of Plan B to 17-year-olds and reconsider its previous decision.
*April 22, 2009 - The FDA allows nonprescription sales of Plan B to 17-year-olds.
Reporting by Susan Heavey; Editing by Richard Chang
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