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JUDGE PERMITS CENTER TO SUBPOENA WHITE HOUSE DOCUMENTS IN LAWSUIT AGAINST THE FDA, CITES "STRONG SHOWING OF BAD FAITH" BY GOVERNMENT

November 6, 2006 -- U.S. Magistrate Judge Viktor Pohorelsky ruled that the Center for Reproductive Rights can subpoena White House documents as part of its lawsuit against the Food and Drug Administration for its failure to make Plan B available without a prescription for women of all ages. Concluding that the Center demonstrated a "strong showing of bad faith" by the FDA in its decision-making around Plan B, Judge Pohorelsky also rejected the government’s request to block the deposition of former White House policy aide Jay Lefkowitz, and granted the Center’s request to depose deputy director of the FDA’s Office of New Drugs, Dr. Sandra Kweder.

The Center subpoenaed the White House for the following documents: communications between the Domestic Policy Office of the White House and select employees of the FDA regarding Plan B between April 2003 and September 2006.

Two Hearings Held in Center’s Case Against the FDA

October 11, 2006 -- Chief Judge Edward R. Korman and Magistrate Judge Viktor V. Pohorelsky held status conferences in Tummino v. von Eschenbach, the Center’s case against the FDA over Plan B. The hearings were held at the U.S. District Court for the Eastern District of New York.

No decisions were reached in either hearing and no dates were set for subsequent hearings.

"Intricate Cover Up" Behind Restrictive FDA Plan B Decision

Agency Decision Comes Weeks after Center Sought to Subpoena White House Documents

August 25, 2006 --Responding to the FDA’s announcement that it would make Plan B available to adult women 18 and over without a prescription by placing it behind the pharmacy counter, Center President Nancy Northup pointed out that months of testimony and discovery in the Center’s lawsuit "show that the agency never intended to fairly consider the scientific evidence that Plan B is safe and effective for women of all ages and that high-level officials engaged in an intricate cover-up that culminated with [today’s] decision."

Media coverage of the FDA’s decision that it would grant restrictive access to Plan B emergency contraception has been quick to recognize the role played by the Center’s lawsuit in the Agency’s decision.

According to The New York Times, "Sworn depositions taken by lawyers from the Center for Reproductive Rights, a legal advocacy organization, show that some of the agency’s staff members were convinced that no amount of scientific evidence would have persuaded the F.D.A.’s political appointees to approve the application."

The Center fully intends to continue to vigorously pursuit its case against the FDA, to fight to true, unrestricted over-the-counter availability by women of all ages.

Depositions Indicate Bush Administration Exerted Political Influence on FDA During Plan B Review Process

Center for Reproductive Rights Requests White House Subpoena

August 3, 2006— Depositions released today by the Center for Reproductive Rights in its lawsuit against the Food and Drug Administration (FDA) indicate that the Bush Administration sought to unduly influence the agency during the Plan B application review process. One senior FDA scientist, Dr. Florence Houn, testified in July that she was told by Dr. Janet Woodcock, then acting deputy commissioner of the FDA, of the need to appease the "administration’s constituents" by rejecting over-the-counter (OTC) status for women of all ages and then approving it down the road with an age restriction. This testimony directly contradicts the testimony of Dr. Woodcock, who earlier testified that she was not aware of any political pressure.

Press Commentary

Center Asks President Bush To Walk the Walk When It Comes to Plan B...

Bush Administration's Recently Stated Position on Contraception is at Odds with Non-Action on "Morning-After Pill"

July 18, 2006--In a letter to the White House this month, the Center urged the Bush administration to reconcile its recently stated position on contraception with the five-year long refusal by the FDA to make Plan B, known as the "morning-after pill," available without a prescription. After keeping silent on the subject of contraception for more than one year, the administration conveyed in a letter to Representative Carolyn B. Maloney (D-NY) that it supports "...safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception."

Center Sends Bush Letter, Urging President To Put Position On Contraception To The Test

July 6, 2006--The Center for Reproductive Rights today urged the Bush administration to reconcile its recently stated position on contraception with the five-year long refusal by the Food and Drug Administration to make Plan B, known as the "morning-after pill," available without a prescription. After keeping silent on the subject of contraception for more than one year, the administration conveyed in a letter to Representative Carolyn B. Maloney (D-NY) that it supports "...safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception."

Despite this view, the Bush administration has taken no constructive action to compel the FDA to increase access to Plan B – a safe and effective medication proven to reduce the risk of pregnancy by approximately 89 percent when it is taken within 72 hours of unprotected intercourse, according to a study published in Obstetrics and Gynecology.

"It is long past time for the FDA to stop the delays, obfuscation and outright refusal to acknowledge what basic science demonstrates," said Nancy Northup, President of the Center for Reproductive Rights in a letter sent yesterday to President Bush. Ms. Northup urged Mr. Bush to put its position on contraception to the test and direct the FDA to immediately approve Plan B for over-the-counter use, "If the administration indeed supports safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception, then there is no reason for its failure to support the availability of emergency contraception."

WHAT'S GOING ON AT THE FDA???

June 20, 2006-- Experts estimate that easy access to the Morning-After Pill could reduce the number of abortions in the U.S. by half. In 2003 FDA’s own panel of experts voted 23-4 in favor of over-the-counter status. Nonetheless, the FDA refuses to make it available to women without a prescription. On Thursday, June 22 at 6:30pm in New York City, legal, medical and feminist advocates will gather to discuss the battle to make the Morning-After Pill an over-the-counter drug in the United States. There will be a panel discussion and a Q and A.

FORMER HEAD OF FDA, DR. MARK McCLELLAN, TO BE DEPOSED ON TUESDAY, JUNE 13

Deposition Comes as FDA Rejects Citizen's Petition Filed Five Years Ago

June 12, 2006--This Tuesday, attorneys from the Center for Reproductive Rights plan to question former FDA Commissioner Dr. Mark B. McClellan in a court-ordered deposition about the FDA’s continued failure to make the emergency contraceptive Plan B available without a prescription. The deposition follows testimony given by three other high level officials and comes just as the agency rejected a citizen's petition filed by the Center in 2001.

WOODCOCK AND GALSON DEPOSITIONS RELEASED

Ex-FDA Chief Yanked Authority from Senior Staff in "Morning-After Pill" Decision, Officials Testify

May 25, 2006-- On May 24, the Center deposed former Commissioner for the Food and Drug Administration Dr. Lester Crawford. The deposition lasted for 8 hours. We will be reviewing the transcripts once they're released. According to previous testimony from the FDA's Deputy Commissioner, Dr. Janet Woodcock, and the Director of the FDA’s Center for Drug Evaluation and Research, Dr. Steven Galson, Crawford repeatedly yanked decision-making powers on Plan B from all other high-level officials. The Center released transcripts from those depositions this week.

AND THE PLOT THICKENS IN FDA "MORNING-AFTER PILL" DECISION. . .

Deposition for Former Head of FDA Rescheduled Amid Astounding Revelations

May 2, 2006--The deposition for the former FDA Commissioner Lester Crawford has been rescheduled for May 24. The change of plans follows revelations that Dr. Crawford is under federal criminal investigation and since January 2005, he cut all other high-level officials out of deciding whether or not to make Plan B available without a prescription--yet another major departure from the agency's usual procedures.

Dr. Crawford's attorney said she had just recently learned about the deposition and needed to determine whether the Center's case might encroach upon the investigation. The New York Times is reporting that the criminal investigation involves financial improprieties and false statements to Congress.

In the meantime, the Center did depose Dr. Steven Galson, Director of the FDA's Center for Drug Evaluation and Research, and Janet Woodcock, the Deputy Commissioner. The Center's attorneys learned that since January 2005, both Galson and Woodcock had been cut out of the decision-making process around Plan B and Crawford served as the sole decision-maker. This is yet another major departure from the agency's typical procedures around determining whether a drug should be made available without a prescription.

Click here to read about the Government Accountability Office's assessment of the FDA's "unusual" decisions surrounding Plan B > >

During January 2005, the FDA was scheduled to decide whether the emergency contraceptive could be sold over-the-counter to women 16 and older. Instead, the agency announced that it would delay making a decision--yet again.

Dr. Crawford's deposition has now been rescheduled for May 24. We'll keep you posted.

Court Finds Strong Showing of "Bad Faith or Improper Behavior by the FDA in "Morning-After Pill" Lawsuit.

February 24 -- The U.S. District Court for the Eastern District of New York issued an order finding that plaintiffs represented by the Center for Reproductive Rights made a strong preliminary showing of the FDA’s "bad faith or improper behavior" in denying over-the-counter status for the emergency contraceptive, Plan B. The Court therefore, denied the government's request for a protective order to block all discovery by the plaintiffs.

This decision means that the plaintiffs have passed a second obstacle to discovery erected by the Department of Justice. In addition to requiring the government to supply documents not previously disclosed, the magistrate judge allows the Center’s attorneys to take depositions (interviews under oath) of high level FDA officials such as former FDA Commissioners Mark McClellan and Lester Crawford.

In January, the federal judge presiding over the entire case denied the government's request to reconsider his December 22nd ruling lifting a stay on discovery. And during an oral argument in December, he questioned whether the agency was acting in good faith, commenting that the case had all the earmarks of an "administrative agency filibuster."

Additional Links

JUDGE DENIES FDA'S LATEST REQUEST IN "MORNING-AFTER PILL" LAWSUIT
Center Entitled to Seek Discovery

Tuesday, January 17-- New York federal district court Judge Edward Korman forcefully denied the government's request to reconsider his December 22nd ruling lifting a stay on discovery. This means the Center is entitled to seek additional information beyond the internal memos we already have received from the FDA -- including email exchanges, office memos, and depositions.

In his order, Judge Korman also said that he would be prepared to rule on our claims that there is an unreasonable delay by the FDA in responding to the 2001 Citizen's Petition submitted by the Center on behalf of 67 medical and public health organizations. The petition asked the agency to grant over-the-counter status to emergency contraception. Read the Judge's Order > >


Lawsuit Against FDA Over "Morning-After" Pill Still Alive
Court Refuses to Dismiss Case after Oral Argument

On Thursday, December 22, a New York federal judge refused to dismiss the Center's lawsuit against the Food and Drug Administration, questioning whether the agency had been acting in good faith by repeatedly refusing to make Plan B available without a prescription. Read the full transcript.

During the oral argument, Judge Edward Korman questioned the FDA's failure to make a decision on Plan B, commonly known as the "morning-after pill." "This has all the earmarks of an administrative agency filibuster," he said. "There's a serious issue here as to whether they're acting in good faith."

The Center's lawsuit asks the court to order the FDA to make Plan B available without a prescription for women of all ages and argues that the agency broke its own rules by ignoring medical fact and holding Plan B to a different standard than other over-the-counter contraceptives. Thursday's oral argument focused on the government's request that the court dismiss the case entirely.


Oral Argument Scheduled for December 22 in Center’s Case Against the FDA

The FDA has already put off making a decision on whether emergency contraception should be made available over the counter for 4 years, and on August 26 the agency called for a 60 day public comment period on its regulatory processes. During that period, which ended November 1, the agency asked the public to comment on whether it should establish rules for dispensing drugs, such as Plan B, that would be made available to some people only by prescription, and to others over-the-counter. Considered by many to be simply another stalling tactic, the public comment period resulted in the resignations of two medical experts working for the FDA. The FDA, they say, is putting politics before women’s health.

We agree. Our case against the FDA is moving forward. We filed suit last January on behalf of a national organization of reproductive health providers, several individual women activists, and a national organization dedicated to improving Latinas’ reproductive health. All of these groups strive to reduce unintended pregnancy rates, including teen pregnancies, by educating women about EC and increasing access to it. According to the plaintiffs, by denying women access to Plan B without a prescription, and by failing to follow its own procedures and statutory and regulatory mandates, the FDA violated the Administrative Procedures Act and the U.S. Constitution. On October 27, a federal judge issued a ruling, asking our lawyers for additional information on our claims against the FDA. That means the case is moving ahead. An oral argument is scheduled to take place in New York City on December 22, 2005.

GAO Report Confirms Center's Lawsuit Against FDA: Agency Not Only Broke Its Rules, but Held Morning-After Pill to Higher Standard

On November 14, 2005, the Government Accountability Office released a report finding that the Food and Drug Administration’s refusal to make the emergency contraceptive, Plan B, available without a prescription was "unusual" and "not typical" of previous decisions on other over-the-counter drugs.

  • Read the Report > >