FDA Scientist Was Told Nonprescription Plan B Application Would Be Rejected "To Appease The Administration's Constituents," Deposition Says

FDA Deputy Commissioner for Operations Janet Woodcock in January 2004 said it was necessary for the agency to reject Barr Laboratories application for nonprescription sales of its emergency contraceptive Plan B in order "to appease the [Bush] administration's constituents," agency scientist Florence Houn testified in a deposition, which was released Thursday by the Center for Reproductive Rights, Reuters reports (Heavey, Reuters, 8/3). The deposition comes in a lawsuit brought by CRR -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others. CRR filed a lawsuit against FDA in a U.S. District Court in New York, claiming the agency did not follow procedure when it denied the original nonprescription Plan B application. FDA in May 2004 issued a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse. Women's Capital later was purchased by Barr. The agency cited inadequate data on Plan B's use among girls younger than age 16. After FDA rejected Barr's first application, the company submitted a revised application to make the drug available only to girls and women ages 16 and older (Kaiser Daily Women's Health Policy Report, 8/1).

Depositions
Houn in a July sworn deposition said Woodcock told her that nonprescription Plan B access had to be rejected for girls and women of all ages but that it eventually could be approved with an age restriction (CRR release, 8/3). CMS Administrator Mark McClellan in a sworn statement taken in June said he gave the White House updates of the application's process but said White House officials did not give "any direction on how I should act" on it (Reuters, 8/3).

White House Request
Federal Magistrate Viktor Pohorelsky, who is hearing arguments in the lawsuit, during a hearing on Thursday gave federal attorneys until Aug. 11 to file an official appeal to block CRR's request for White House records related to Barr's application, the AP/San Diego Union-Tribune reports (Hays, AP/San Diego Union-Tribune, 8/3). CRR in a July 21 letter to Pohorelsky requested that the White House provide any letters, e-mails or records of conversations its staff exchanged with FDA in regard to Barr's application (Kaiser Daily Women's Health Policy Report, 8/1). Federal attorneys earlier this week asked Pohorelsky to "quash these requests in their entirety, or, in the alternative, to strictly limit the scope of discovery which plaintiffs are allowed to take from the White House." Pohorelsky said, "It's a question of whether these areas of inquiry into the White House are appropriate" (AP/San Diego Union-Tribune, 8/3). CRR also is seeking to depose White House official Jay Lefkowitz. CRR attorney Bonnie Jones in May told Pohorelsky that McClellan, while head of FDA, had a discussion with a White House official about Plan B. A copy of McClellan's appointment calendar for April 21, 2003, a few days after Women's Capital's application submission, reads, "Conference call w/Jay Lefkowitz re: Plan B submis." Lefkowitz is the former deputy assistant to President Bush on domestic policy and currently serves as special envoy on human rights in North Korea (Kaiser Daily Women's Health Policy Report, 8/1). The government has said it will seek to prevent a subpoena of Lefkowitz (AP/San Diego Union-Tribune, 8/3).

NPR on its Web site published the depositions released Thursday (Rovner, NPR, 8/3). Expanded NPR coverage, including transcripts of the depositions by FDA officials from June and July, is available online.

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