July 31, 2006

An activist group that is suing the FDA over its handling of the controversial contraceptive Plan B is asking to subpoena all White House documents related to the issue after a top agency official allegedly acknowledged that its decision on the drug was made to "appease the administration's constituents," according to documents obtained by FDAnews.

The Center for Reproductive Rights (CRR) is asking a federal court to allow it to subpoena all written communication between the White House, the FDA and HHS on Plan B. CRR also wants all records of oral communications between White House employees and agency officials, along with any documents "memorializing direction or suggestion by the White House" to any agency officials on Plan B.

This new request springs from CRR's discovery that a high-ranking FDA official is alleged to have said that the White House directly influenced the agency's decision on Plan B. To date, the agency has denied that the White House played any role in this issue.

Janet Woodcock, currently the agency's deputy commissioner for operations, told Florence Houn, the deputy director of the CBER's Office of Vaccines Research and Review, that the agency could not approve Plan B for political reasons, Houn said at a July 20 deposition. Woodcock told Houn in January 2004 that "the only way to go [was] to issue a non-approval letter to appease the administration's constituents, and then later [the Plan B OTC switch] could be approved," according to the deposition transcripts.

CRR needs the subpoena because the revelation about the White House's alleged role makes the documents necessary to determine whether "the agency's bad faith and improper behavior" is the reason for its handling of Plan B, CRR wrote in a July 21 letter to Magistrate Judge Viktor Pohorelsky of the U.S. District Court for the Eastern District of New York. The group is also requesting the court's permission to depose Jay Lefkowitz, President Bush's former assistant for domestic policy, to determine if he influenced the agency's decision to delay OTC approval.

The judge is planning a hearing Aug. 7 to decide on these requests, Todd Glass, a spokesman for CRR, said.