February 14, 2001: The Center for Reproductive Rights files a citizens’ petition with the FDA on behalf of over 70 other medical and public heath organizations to make Plan B available over-the-counter (OTC).

Late 2002/Early 2003: In anticipation of Plan B OTC application, a political deal is made at the FDA to delay action on the drug for as long as possible and then, when push comes to shove, grant restricted access. (source: Houn, Jenkins & Wood depositions)

April 21, 2003: Women's Capital Corporation files an application with the FDA to change status of Plan B from prescription-only to OTC for all ages (Barr Pharmaceuticals later buys Plan B).
Simultaneously, then-FDA Commissioner Mark McClellan holds 5:30pm meeting about Plan B with White House domestic policy advisor Jay Lefkowitz.

December 16, 2003: An independent FDA panel of experts recommends Plan B for OTC status by a vote of 23 of 4. The panel makes a unanimous finding that Plan B is safe and effective.

Late December 2003/January 2004: Dr. Steven Galson, Director of the FDA’s Center for Drug Evaluation & Research, informs members of the scientific review staff that typical procedures will be changed and that the staff will be completely shut out of the final decision concerning Plan B. (Jenkins deposition)

Dec-Jan 15, 2004: Galson confesses to Dr. John Jenkins, Director of the FDA’s Office of New Drugs, that he "didn't have a choice" but to reject Barr's application because he was afraid he would lose his job. (Jenkins deposition)

January 15, 2004: Galson holds a meeting with the review staff, making it clear that Commissioner McClellan has already decided to reject application, then grant access with an age restriction. (Jenkins & Houn depositions)

January 15-17, 2004: During a phone conversation, Dr. Janet Woodcock, then-Acting Deputy Commissioner for Operations, divulges to Dr. Florence Houn, Director of the FDA’s Office of Drug Evaluation III, that denying Barr’s application, then granting limited approval is "the only way to go" to "appease the administration's constituents." (Houn deposition)

May 4 or 5, 2004: Galson tells Dr. Susan Wood, Director of the FDA’s Office of Women's Health, that denying Barr's application was necessary in order for him to keep his job. (Wood deposition)

May 6, 2004: The FDA denies the Barr application, overriding the recommendations of its professional staff, and suggests Barr amend the application for women ages 16 and older.

July 22, 2004: Barr Pharmaceuticals submits a revised "dual label status" proposal that would make Plan B available with a prescription for women aged 16 and older.

January 2005: Galson prepares approval of Barr application with a 17 & older age restriction. (Jenkins deposition) But, according to the Galson deposition, Acting Commissioner Lester Crawford (who succeeds McClellan) mysteriously yanks Galson's authority in the process and informs Galson that he will take over.

January 21, 2005: The FDA fails to issue a decision on the Plan B application within the previously scheduled time. The Center for Reproductive Rights files a lawsuit against the agency on behalf of reproductive health groups and activists for its continued failure to grant Plan B OTC status. The suit claims that the FDA broke its own rules and regulations by ignoring science and holding Plan B to a different standard than other OTC drugs.

April 6, 2005: Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) place a "hold" on Crawford's nomination as FDA Commissioner due to the agency's failure to make any decision on Plan B.

July 15, 2005: Senators Murray and Clinton lift the "hold" on Crawford's nomination in exchange for a promise from Health and Human Services (HHS) that the FDA would act on the Plan B application by September 1, 2005.

August 26, 2005: Despite HHS’ promise, the FDA once again delays action on Plan B — this time indefinitely. The agency announces a request for public input on dispensation of the drug — something the agency has never done. The process has no incorporated timelines.

October 12, 2005: The Government Accountability Office (GAO) releases a report on the Plan B controversy, finding that the decision-making around the drug was highly unusual and made with atypical involvement from high-level officials.
Read the GAO Report > >

December 22, 2005: A federal judge denies an earlier Department of Justice request to dismiss the Center's lawsuit, calling the FDA inaction on Plan B "an administrative agency filibuster."

February 24, 2006: The Center is cleared to depose high-level FDA officials. The New York magistrate judge cites strong showing of "bad faith and improper behavior" by the FDA.

March 15, 2006: Acting Commissioner Andrew von Eschenbach is nominated to head the FDA. Senators Murray and Clinton block his confirmation vote.

June 13, 2006: In sworn deposition, former Commissioner McClellan claims that he did not make the decision about Plan B’s over-the-counter status or direct Galson to act in any particular way on Plan B - directly contradicting the testimony given by Jenkins, Houn, and Wood. (see January 15, 2004)

July 18/19, 2006: Dr. Curtis Rosebraugh, Deputy Director of the FDA’s Division of OTC Drug Products, is deposed. He confirms that scientists involved in the process believe that the decision was influenced by political considerations.

July 21, 2006: The Center asks the court to subpoena White House documents and to depose former White House aid, Jay Lefkowitz, on the mysterious April 21, 2003 meeting with McClellan. Thirteen days later, in response to government requests, the hearing is postponed until September 21st.

July 31, 2006: Von Eschenbach announces the plan to make Plan B available without a prescription to women age 18 and older.

August 1, 2006: The Senate holds a hearing for von Eschenbach wherein Senators renew their "hold" on confirmation until the FDA acts on Plan B.

August 23, 2006: The FDA agrees to make Plan B available without a prescription, but only to women 18 & older and behind pharmacy counters. In response, the Center releases a statement that the FDA engaged in intricate cover-up that culminated with the decision. The Center vows to continue the lawsuit.

November 6, 2006: Federal judge rules that the Center can subpoena White House documents as part of its lawsuit and concludes that the Center demonstrated a "strong showing of bad faith" by the FDA in its decision-making around Plan B.

November 16, 2006: The Center issues subpoenas to the White House in its case against the FDA, asking to see communications between the Domestic Policy Office of the White House regarding Plan B between April 2003 and September 2006. As expected, the government objects to the subpoena request.

February 13, 2007: Federal judge grants Center's request for further discovery of additional FDA documents. He also issues stay on the White House documents, saying he will consider that request once he has seen all of the evidence.

March 30, 2007: Center files for summary judgment in case, arguing that the undisputed facts found in evidence gathered through discovery make it unnecessary for the court to hold a trial, and that the court should order the FDA to make Plan B available without a prescription to women of all ages.