Role in Center For Reproductive Rights Lawsuit
During McClellan's tenure as Commissioner of the FDA, the makers of Plan B emergency contraception applied for over-the-counter status.
In May 2004, FDA commissioner Steven Galson rejected over-the-counter status for Plan B. The Center for Reproductive Rights then filed a lawsuit, and deposed Dr John Jenkins, director of the FDA's Office of New Drugs. Jenkins alleges that he learned in early 2004 that McClellan, then Commissioner of the FDA, had decided against approval even before the staff could complete their analysis. "I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins stated. He later said he did not know if anyone outside FDA influenced the decision.
McClellan said in his deposition that he was not involved in the decision to reject the initial Plan B application for non-prescription sales; he left the FDA in February 2004 to head the agency that runs Medicare and Medicaid. He also said that he was never told by anyone higher up in the Bush administration what to do about the application, although he did say that he "briefed" two White House domestic-policy advisors. The litigation is ongoing; no finding has been made for either side.
Read more about this topic: Mark McClellan
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