Former FDA commissioner Mark McClellan had a discussion with a White House official about Barr’s emergency contraceptive Plan B while the drug’s application for non-prescription sales was still pending, Long Island, NY, newspaper Newsday reported.
Bonnie Jones, an attorney for the New York City based Center for Reproductive Rights (CRR) told a federal judge last Thursday, “It has come to our attention that Mark McClellan at some point had a meeting with someone from the White House about Plan B.”
A copy of McClellan’s appointment calendar while he was FDA commissioner contains an April 21, 2003, entry: “conference call with Jay Lefkowitz re:Plan B submis.,” the article said. The entry appears to refer to the application for nonprescription sales submitted to the FDA a few days earlier by Women’s Capital Corp., which then owned Plan B, later purchased by Barr.
Lefkowitz is former deputy assistant to the president for domestic policy and now serves as a special envoy on human rights in North Korea.
Calls to McClellan and Lefkowitz seeking comment were not immediately returned, according to the Newsday article.
In May 2004, the FDA issued a non-approvable letter to Barr’s request to allow OTC sales of Plan B. In January 2005, the FDA announced a delay in its decision on a revised application.
Jones was in federal court in New York last week to represent CRR and others in a lawsuit against the FDA claiming the agency did not follow procedure when it first denied the Plan B application. The lawsuit also said that by not approving nonprescription sales of Plan B, the FDA violated women’s rights to equal protection and privacy as guaranteed by the US Constitution.
McClellan is scheduled to testify in the case on June 13 in Washington, DC.
Another former FDA commissioner, Lester Crawford, recently refused to be deposed in the case. His attorney said he would have to invoke the Fifth Amendment. Crawford is scheduled to testify on May 24.