Testimony made by another high-ranking FDA official may bolster the Center for Reproductive Rights' allegations of inappropriate White House involvement in FDA's review process for the Plan B switch.

FDA's 2003 decision to reject Barr's Plan B OTC application "was not one that [former FDA Commissioner Mark] McClellan had made on his own," FDA's Office of New Drugs Deputy Director Sandra Kweder, M.D., stated in her Dec. 11 deposition.

"The White House was involved in what we were told, and that it was made very clear that there were a lot of constituents who would be very unhappy with...an over-the-counter Plan B," Kweder says in a court transcript released by CRR Dec. 22.

CRR filed suit against FDA in 2001 in the U.S. District Court for the Eastern District of New York to make the emergency contraceptive available to women of all ages without a prescription.

In November, Barr started shipping Plan B to pharmacies for over-the-counter sale to individuals 18 and over. Minors must obtain prescriptions to lawfully obtain the drug.

CRR subpoenaed the White House Nov. 16 for records of communications between the Executive Office and FDA about the Plan B review process, a move the Justice Department characterized as a "fishing expedition" in a Nov. 30 request to stay the subpoena (¹ Also see "CRR Granted Subpoena For White House/FDA Plan B Communications" - Pink Sheet, 13 November, 2006., p. 7 and ² Also see "Court Lets FDA Off Plan B Subpoena Hook; White House Says No To CRR" - Pink Sheet, 4 December, 2006., p. 5).

"The government may continue to fight against our efforts to expose the truth, but as this latest deposition confirms - the White House's involvement in this process is highly suspicious and improper," Simon Heller, the lead attorney for CRR, states in a Dec. 22 release.

The group says it plans to continue seeking "pertinent documents and take the appropriate steps to compel the White House to turn over documents."

CRR seeks to depose former White House policy aide Jay Lefkowitz, but it must wait for a court ruling on FDA's appeal to shield Plan B related documents from release.

- Jessica Lake

Kweder Deposition Strengthens Link Between White House, Plan B – CRR

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