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

Center for Reproductive Rights Requests White House Subpoena

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 aware of political pressure.

The Center for Reproductive Rights' request to subpoena the White House, discussed at a hearing at U.S. District Court for the Eastern District of New York today, was, in part, based upon the revelations disclosed in the depositions of Dr. Mark McClellan and Dr. Florence Houn which the Center released today. The Center also released the depositions of two FDA scientists, Dr. Curtis Rosebraugh and Dr. Donna Griebel, who testified to the unusual involvement from senior FDA management at the earliest stages of the Plan B review process.

Based on testimony given in June by former FDA Commissioner Dr. McClellan, who now serves as Administrator for the Centers for Medicare and Medicaid, the Center for Reproductive Rights is also seeking to depose Jay Lefkowitz, a former White House domestic policy advisor, regarding conversations he had with Dr. McClellan during the FDA's review process of Plan B. Deposing Mr. Lefkowitz would allow the Center to test the veracity of Dr. McClellan's testimony that his conversations with Mr. Lefkowitz were merely "updates" related to press inquires and to see what other uses the White House made of these updates.

"The evidence we have uncovered in the course of deposing a number of FDA scientists and officials reveals that the FDA submitted to political pressure from the Bush Administration in rejecting over-the-counter status for Plan B," said Simon Heller, the lead attorney for the Center of Reproductive Rights in its case against the FDA. "Only by subpoenaing the White House will we be able to fully explore the extent of this improper influence exerted by the Administration over the FDA during the Plan B application review."

Mr. Heller also noted that new requirements, such as showing how a dual marketing program will be enforced, the FDA placed on Barr Pharmaceuticals in order to gain over-the-counter status for Plan B would have absolutely no effect on the lawsuit. The requirements, announced just prior to this week's Senate nomination hearing of Dr. Andrew C. von Eschenbach to head the FDA, would still violate the constitutional rights of women in need of emergency contraception and would perpetuate the agency's non-scientific reasons for denying over-the-counter access for younger women.

BACKGROUND:

The lawsuit Tummino v. von Eschenbach was filed on January 21, 2005, by the Center for Reproductive Rights in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy.

Since 2001, medical, public health, and reproductive rights organizations have been requesting the FDA to make the ‘morning-after pill' available without a prescription. Unfortunately, the agency has repeatedly denied those requests while at the same time claiming that it was still actively considering them. Last month, the agency finally acknowledged that it had denied the Center for Reproductive Rights' citizen petition for granting emergency contraception over-the-counter status. But it took this step only in response to the lawsuit and as a means to try to evade judicial review of the agency's actions.

Every 10.5 seconds, an unplanned pregnancy occurs in the United States-an estimated three million such pregnancies every year. And each year, 1.29 million end in abortion. Researchers at the Guttmacher Institute, a nonprofit reproductive health research organization, have concluded that better access to emergency contraception could prevent half of those pregnancies, including those that now end in abortion. Had the FDA approved emergency contraceptives for over-the-counter use when we submitted the citizen's petition, many of the 16 million unplanned pregnancies-and subsequent abortions-that occurred in the five years since could have been avoided.