Milestones on Road to Over-the-Counter Plan B:

• July 1999: The U.S. Food and Drug Administration approves Plan B, a levonorgenstrel-only emergency contraceptive (EC) pill, finding it safe and effective for women of all ages to use as a prescription product.

• February 2001: RHTP and the Center for Reproductive Rights, on behalf of more than 70 medical and public health organizations, file a Citizen's Petition with the U.S. Food and Drug Administration to make EC available over-the-counter (OTC).

• April 21, 2003: The manufacturer of Plan B files an application with the FDA to make it available over-the-counter.

• December 16, 2003: FDA independent panel of experts votes 23 to 4 to recommend Plan B be made available OTC, with no age restriction. The panel also voted unanimously that Plan B is safe for nonprescription use.

• May 6, 2004: Dr. Steven Galson, Acting Director of the Center for Drug Evaluation and Research overrides FDA professional staff recommendations and issues a “not approvable” letter to Plan B’s manufacturer, citing concerns about young teens using the drug.

• July 22, 2004: Plan B manufacturer submits a revised over-the-counter proposal to FDA, which would make it available to women 16 and older without a prescription while requiring one for women 15 and under.

• January 21, 2005: FDA fails to issue a decision on the Plan B application by the deadline imposed under the federal law governing performance standards for drug approvals.

• March 17, 2005: Members of the Senate HELP Committee question FDA Acting Commissioner Lester Crawford about the agency’s inaction on the Plan B OTC application during hearings on his nomination to permanently head the FDA. Unsatisfied with Crawford’s answers, Sens. Clinton (D-NY), Murray (D-WA) and Kennedy (D-MA) request a closed-door meeting with him.

• April 6, 2005: Following the closed-door meeting, Sens. Clinton (D-NY) and Murray (D-WA) announce their intention to place a “hold” on Crawford’s nomination, citing the FDA’s failure to act on a host of public health issue—including the Plan B OTC application—during Crawford’s tenure as acting commissioner as the reason for the hold.

• May 15, 2005: News reports indicate that David Hager, a controversial member of the FDA’s Reproductive Health Drugs Advisory Committee, was asked to author an unprecedented minority opinion opposing FDA approval of OTC access for Plan B — after the advisory panel voted overwhelmingly to support the application.

• July 15, 2005: Senators Clinton and Murray lift the “hold” on Crawford’s nomination to head the FDA after receiving assurances from Health and Human Services Secretary Mike Leavitt that the FDA will act on the Plan B OTC application by September 1.