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Tummino, et al. v. von Eschenbach

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Synopsis

CCR represents several feminist activists from the “Morning-After Pill Conspiracy” in a lawsuit to challenge the Food and Drug Administration’s failure to approve the Morning-After Pill (also known as “emergency contraception” or “Plan B”) with unrestricted over-the-counter access for all women in the U.S. regardless of age. The case, and the related MAP Conspiracy organizing campaign, expose how the FDA’s actions relied on anti-birth control politics, not women’s rights or scientific evidence, in the decision making process.

Status

On March 23, 2009, Judge Edward Korman ruled that the FDA must reconsider its decisions regarding the Plan B switch to OTC use. The FDA was further ordered to permit Barr Pharmaceuticals, Inc. to make Plan B available to 17 year olds without a prescription within 30 days. Scroll down to read the full memorandum and order.

Description

CCR represents several feminist activists from the “Morning-After Pill Conspiracy” in a lawsuit against the Food and Drug Administration to challenge the failure to approve the Morning-After Pill (also known as “emergency contraception” or “Plan B”) with unrestricted over-the-counter access for all women in the U.S. regardless of age. The case, and the MAP Conspiracy organizing campaign, expose how the FDA’s actions relied on anti-birth control politics, not women’s rights or scientific evidence, in the decision making process.

The plaintiffs are asking the court to order the FDA to make Plan B available without a prescription for women of all ages. Decades of scientific research and women’s life experience show that Plan B is effective and safe for self-medication. For example, an internal FDA memo acknowledges that the clinic data before the agency “clearly supports” making Plan B available without a prescription “for all age groups,” and that such approval would be “consistent” with previous decisions on other products. Another internal agency memo indicates that the FDA has not previously “distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women,” and there is no “compelling scientific reason” for such a distinction in this case. By ignoring scientific facts and holding Plan B to a different and higher standard than used for other over-the-counter drugs, the FDA is failing to follow its own procedures and statutory and regulatory mandates. (From “Key Points of the Lawsuit,” of the Center for Reproductive Rights.)

The plaintiffs also assert that the FDA has violated women’s constitutional rights to privacy and equal protection by unlawfully restricting access to contraception and discriminating against women who are the exclusive users of Plan B.

After years of unexplained delays and inaction, on August 23, 2006, the FDA approved the switch of Plan B from prescription only to over-the-counter availability for individuals age 18 and over. In practice, this means that Plan B can only be obtained from behind a pharmacy counter for women 18 and older, but only if they show identification. In the position paper, “Morning-After Pill Age Restrictions Restrict All Women: FDA Tries to Divide Women by Age to Deny Us Our Rights,” plaintiff Jenny Brown of Gainesville Women exposes the anti-woman politics in the FDA’s position to restrict young women’s access to Plan B. Since the FDA’s decision in August 2006 is only a partial victory, the fight for reproductive rights and access to contraception moves forward.

The Court has concluded that there is a “strong showing of bad faith” on the part of the FDA and testimony from high-level FDA officials and documents obtained in discovery show the agency’s decision was not based on science, but, rather, due to improper political influence. The lawsuit seeks to ensure that Plan B is granted true over-the-counter status and made widely available to women of all ages.

 

Timeline

The lawsuit was filed on January 21, 2005, in the U.S. District Court for the Eastern District of New York. CCR represents several feminist activist Plaintiffs in the lawsuit. The case is in cooperation with the Center for Reproductive Rights as lead counsel and Natalie Maxwell of Southern Legal Counsel as co-counsel for the MAP Conspiracy plaintiffs. Other Plaintiffs include: the Center for Reproductive Rights, the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and young women and their parents.

On December 22, 2005, Judge Edward Korman heard arguments on the agency’s motion to dismiss the lawsuit and refused to do so.

The Court, in an Order issued on February 24, 2006, found that the plaintiffs should be permitted to seek additional discovery concerning the FDA’s decision-making process and to take the depositions of high-level FDA officials.

The plaintiffs filed an Amended Complaint on October 10, 2006.

On November 6, 2006, the Court issued an Order allowing plaintiffs to conduct discovery into the White House’s role in the Plan B decision. The agency filed objections to this Order and the Court granted a stay and extension to allow the plaintiffs to proceed with their motion for summary judgment and to revisit the White House discovery issue, if necessary.

In February 2007, the Court granted the plaintiffs’ request for further discovery of additional FDA documents.

On March 30, 2007, the plaintiffs filed for summary judgment 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 agency to make Plan B available without a prescription to women of all ages.

On May 26, 2007, the agency filed a Motion to Dismiss the Fifth Amended Complaint or in the alternative for summary judgment.

The parties are waiting for the Court’s decision on their pending summary judgment motions.

(* The organizing campaign timeline compiled by the MAP Conspiracy is also included. For more information about the organizing campaign go to www.mapconspiracy.org)