Mark McClellan - Role in Center For Reproductive Rights Lawsuit

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

Famous quotes containing the words role in, role, center, reproductive and/or rights:

    Always and everywhere children take an active role in the construction and acquisition of learning and understanding. To learn is a satisfying experience, but also, as the psychologist Nelson Goodman tells us, to understand is to experience desire, drama, and conquest.
    Carolyn Edwards (20th century)

    The role of the stepmother is the most difficult of all, because you can’t ever just be. You’re constantly being tested—by the children, the neighbors, your husband, the relatives, old friends who knew the children’s parents in their first marriage, and by yourself.
    —Anonymous Stepparent. Making It as a Stepparent, by Claire Berman, introduction (1980, repr. 1986)

    The question of whether it’s God’s green earth is not at center stage, except in the sense that if so, one is reminded with some regularity that He may be dying.
    Edward Hoagland (b. 1932)

    The blind conviction that we have to do something about other people’s reproductive behaviour, and that we may have to do it whether they like it or not, derives from the assumption that the world belongs to us, who have so expertly depleted its resources, rather than to them, who have not.
    Germaine Greer (b. 1939)

    The rights of persons, and the rights of property, are the objects, for the protection of which Government was instituted.
    James Madison (1751–1836)