Timeline: The Debate over Plan B
An overview of the political and regulatory battle to allow over-the-counter sales of the emergency contraceptive known as the "morning-after" pill:
July 28, 1999: The FDA approves Plan B as a prescription-only medication.
Feb. 14, 2001: More than 60 medical and consumer groups file a "citizen's petition" with the FDA to make emergency contraception available over the counter, arguing that the two-pill regimen is safe enough, effective enough and simple enough to be sold without physician supervision.
April 16, 2003: Women's Capital Corporation files an application to change the status of Plan B from prescription-only to over the counter for all age groups.
Oct. 2, 2003: Barr Pharmaceuticals announces it has agreed to purchase Plan B and other assets from Women's Capital Corporation.
Dec. 16, 2003: Two FDA advisory committees, meeting jointly, vote 23-4 that Plan B should be made available without prescription to all age groups. The committees also vote 27-1 that Plan B can be used safely by all age groups.
Feb. 13, 2004: A week before a decision is due, the FDA announces it will taken an additional 90 days to decide on the over-the-counter application. It originally had 10 months from the April 2003 filing to decide.
Feb. 26, 2004: Barr completes its purchase of Women's Capital Corporation.
May 6, 2004: The FDA rejects the application to make Plan B over the counter for all age groups. In a letter to the company, the FDA says the company had not presented enough data to ensure the drug can be used safely by girls under age 16 without a doctor's supervision. But the agency did suggest the company could reapply -- if it could propose a way to make the product available over the counter for those 16 and older -- while still requiring younger teens to get a prescription.
July 22, 2004: Barr submits a revised application to the FDA that would allow Plan B to be sold without a prescription to those age 16 and over. For those younger, the drug would remain available by prescription only.
Jan. 21, 2005: The FDA misses its statutory deadline to rule on the revised application. The Center for Reproductive Rights files suit in federal district court to force the agency to approve the original application for over-the-counter availability for all ages.
Feb. 14, 2005: Lester Crawford is nominated as commissioner of the FDA, to replace Mark McClellan, who left in 2004 to head the agency that runs Medicare and Medicaid.
April 8, 2005: Sens. Patty Murray (D-WA), and Hillary Rodham Clinton (D-NY) announce they will block a vote on Crawford's nomination until the FDA rules on Barr's Plan B application.
July 15, 2005: Sens. Murray and Clinton release their hold on Crawford's nomination when HHS Secretary Michael Leavitt writes a letter promising a ruling on the application by September 1.
July 18, 2005: Crawford is confirmed as FDA commissioner after Murray and Clinton release their hold.
Aug 26., 2005: The FDA announces it will file an "advance notice of proposed rulemaking" -- providing 60 days of public comment -- rather than render a final decision on Barr's application. Crawford says the prospect of restricting sales of an over-the-counter medicine based on age raises "novel questions" that might require new regulations.
Aug. 31, 2005: Susan Wood, director of the FDA's Office of Women's Health, resigns over the agency's failure to approve the Barr application, saying the agency's latest action "is denying all women the appropriate access to this product, which is clearly safe and effective for its use."
Sept. 23, 2005: FDA Commissioner Lester Crawford resigns abruptly, just two months after his confirmation, for reasons never made clear publicly. Andrew Von Eschenbach, a Bush family friend and head of the National Cancer Institute, is named acting commissioner.
Nov. 14, 2005: The Government Accountability Office says in a report that the FDA failed to follow its own procedures in its deliberations over the Plan B over-the-counter application.
March 15, 2006: President Bush formally nominates Von Eschenbach to be permanent head of the FDA. Clinton and Murray say they will not allow a Senate vote on the nomination until Barr's Plan B application gets a yes or no answer.
June 9, 2006: The FDA formally denies the 2001 citizen's petition to allow over-the-counter sales of Plan B, citing a lack of data on safe use by younger women.
July 31, 2006: In the FDA's first action on drugmaker Barr's application in nearly a year, acting commissioner Von Eschenbach sends a letter to the company saying he has decided no new regulations will be necessary, but that any over-the-counter sales should be restricted to those age 18 and over. The letter comes a day before Von Eschenbach's confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.
Aug. 1, 2006: Von Eschenbach refuses at his confirmation hearing to say when a decision will be made on the Plan B application. Sens. Murray and Clinton renew their hold on Von Eschenbach's nomination until a decision is made.
Aug. 23, 2006: The FDA approves sale of Plan B without a prescription only to those age 18 and over. To ensure enforcement of the age restrictions, the drug will be sold only in pharmacies, clinics, or other facilities staffed by a health care professional, and kept "behind the counter," so it can be dispensed only to individuals with either a prescription or proof of age. In the Senate, Murray and Clinton announce they will drop their hold on the Von Eschenbach nomination.