October 9, 2006
Seek White House Subpoena
in Morning-After Pill Case
**Court Hearing in Brooklyn on October 11th, 2006, 2:30pm**
After nearly three long years of delay, the FDA finally approved behind-the-counter sales of the Morning-After Pill (brand name Plan B) for some women 18 years and older. The FDA has touted its recent decision as a final step to expand access to the Morning-After Pill. However, feminists and health advocates have deep concerns about the restrictions being placed on the pill. The FDA's decision goes against the advice of its own scientific advisory committee, which recommended over-the-counter sales for women of all ages in December, 2003.
"We already have evidence of White House influence over the decision making process," said Annie Tummino, lead plaintiff in the lawsuit, Tummino v. von Eschenbach, charging the FDA with holding Plan B to a different standard than it does other drugs. "Isn't it curious that the FDA finally made a ruling right as the Center requested a subpoena of White House documents?"
In July, a senior FDA scientist testified under oath that Deputy Commissioner Dr. Janet Woodcock informed her of the need to appease the "administration's constituents" by rejecting over-the-counter status for women of all ages and then approving it later on with an added age restriction. (The depositions can be found online at http://www.reproductiverights.org/). This contradicted Woodcock's own testimony that she wasn't aware of any political pressure.
In order to uncover the full extent of the Bush administration's influence on the Plan B application, the plaintiff's attorneys are requesting a subpoena of White House documents. They also seek to depose Jay Lefkowitz, a former White House domestic policy advisor, regarding his conversations with former FDA Commissioner Marc McClellan during the FDA's review process of Plan B. Government attorneys are resisting the subpoena.
Tummino v. von Eschenbach was filed in January 2005 in U.S. District Court for the Eastern District of New York by the Center for Reproductive Rights and Southern Legal Counsel. The suit was filed on behalf of 9 women associated with the Morning-After Pill Conspiracy, a grassroots feminist organization, as well as the National Latina Institute for Reproductive Health and the Association of Reproductive Health Professionals. The suit charges the FDA with discrimination against women and failing to follow normal agency procedures in their handling of the Plan B application.
"Feminists will continue to mobilize against the restrictions on the Morning-After Pill," said Tummino, Lead Plaintiff and Chair of the NY based Women's Liberation Birth Control Project. "Women of all ages need immediate access."
What: Morning-After Pill Court Hearing
Where: Court House, 225 Cadman Plaza East in Brooklyn. Take 2/3 to Clark St Station, 4/5 to Borough Hall or M/R to Court St./Borough Hall. (Bring ID)
When: Wednesday, October 11th: 2:30 pm in front of Chief Judge Korman, followed by hearing in front of Magistrate Judge Pohorelsky (3:30 or when 1st
For More Information, Contact:
Annie Tummino, Lead Plaintiff, at 917-842-5306
Center for Reproductive Rights at 917-637-3649
****** UPDATE ******
US Judge Likely to Allow Discovery in Plan B Suit
Wed Oct 11, 2006 6:48pm ET
by Anna Driver
NEW YORK, Oct 11 (Reuters) - A federal judge said on Wednesday he was inclined to let evidence gathering continue in a lawsuit over the morning-after contraceptive pill, but stopped short of ruling whether the plaintiffs can subpoena documents and testimony from the White House.
A lawsuit filed by the The Center for Reproductive Rights on behalf of plaintiffs alleges the U.S. Food and Drug Administration has repeatedly broken its own regulations in denying women of all ages increased access to the Plan B contraceptive.
The rights group also claims that testimony from depositions it has taken so far show agency officials planned to drag out the approval process for the contraceptive for political reasons.
Evidence gathering in the case has stalled as Magistrate Judge Viktor Pohorelsky mulls whether the plaintiffs can subpoena White House documents and testimony from former White House policy aide Jay Lefkowitz and deputy FDA director Dr. Sandra Kweder.
"I'm inclined the to permit discovery be completed," Magistrate Judge Viktor Pohorelsky said in U.S. District Court in Brooklyn. "How much, I don't know."
The Center for Reproductive Rights filed its first complaint in January 2005 over the FDA's failure for make Plan B available without a prescription for women of all ages.
But in August, officials from the agency ruled the Plan B contraceptive could be sold to adults without a prescription, which some saw as ending the three-year fight over wider access and use by teenagers.
Franklin Amanat, who represents the FDA in the case, said they plan to file a motion to have the case dismissed in light of the agency's decision to allow the "vast majority who would purchase the drug" over-the-counter access to it.
But the rights group argued their claim is still valid because the agency's entire decision making process on Plan B was marred by politics, a sentiment with which another judge appeared to agree.
In another hearing on the case held earlier in the day before Chief Judge Edward Korman in Brooklyn, the judge repeated a sentiment he expressed earlier, saying the entire case "reeks with bad faith" on the part of the FDA.
Barr Pharmaceuticals Inc. applied for over-the- counter status for Plan B in 2003.
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