FDA chief's secret 'Plan B' meeting

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FDA chief's secret 'Plan B' meeting

By Kathleen Kerr, Newsday, May 12, 2006

An attorney for a women's rights group told a Brooklyn federal magistrate yesterday that while a controversial emergency contraceptive was pending before the Food and Drug Administration, it was the topic of discussion by a White House official and the then-FDA commissioner.

Advocates of Plan B, the so-called "morning-after" pill, have long suggested the White House influenced the FDA's decision not to allow over-the-counter sales of the pill, which the agency had determined is safe. White House consultations seldom, if ever, are part of the FDA drug approval process.

The Manhattan-based Center for Reproductive Rights is in court seeking to force the FDA to approve over-the-counter sales of Plan B. Two FDA officials have resigned in protest over the agency's refusal to allow such sales.

Yesterday, Bonnie Jones, an attorney for the reproductive rights group, told federal Magistrate Viktor Pohorelsky: "It has come to our attention that Mark McClellan at some point had a meeting with someone from the White House about Plan B." McClellan, now administrator of the Centers for Medicare and Medicaid Services, worked as senior policy director for health care in the Bush White House in 2001 and 2002.

A copy of McClellan's appointment calendar while he was FDA commissioner contains an April 21, 2003 entry: "Conference call w/Jay Lefkowitz re: Plan B submis." The entry appears to refer to an application for non-prescription sales submitted to the FDA a few days earlier by Women's Capital Corp., which then owned Plan B. Barr Laboratories of Pomona, N.Y., later bought the company.

Lefkowitz, popular with conservative groups, is the former deputy assistant to the president for domestic policy and now serves as special envoy on human rights in North Korea.

McClellan and Lefkowitz did not immediately return telephone calls for comment. A Barr spokeswoman had no comment.

Jones was in court seeking to obtain deleted FDA e-mails as well as permission to depose five agency officials who favored non-prescription Plan B sales. Assistant U.S. Attorney Franklin Amanat asked Pohorelsky to block the depositions; the judge refused and did not rule on the e-mail request. "These are, at best, all low- to mid-level managers within the agency," he argued.

Another former FDA commissioner, Lester Crawford, recently refused to be deposed; his attorney said he would have to invoke the Fifth Amendment. Crawford is expected to testify on May 24. McClellan is scheduled to testify in Washington, D.C., on June 13.

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