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, center, reproductive and/or rights:
“Whether or not you have children yourself, you are a parent to the next generation. If we can only stop thinking of children as individual property and think of them as the next generation, then we can realize we all have a role to play.”
—Charlotte Davis Kasl (20th century)
“Every beloved object is the center point of a paradise.”
—Novalis [Friedrich Von Hardenberg] (1772–1801)
“In the nineteenth century ... explanations of who and what women were focused primarily on reproductive events—marriage, children, the empty nest, menopause. You could explain what was happening in a woman’s life, it was believed, if you knew where she was in this reproductive cycle.”
—Grace Baruch (20th century)
“... the constructive power of an image is not measured in terms of its truth, but of the love it inspires.”
—Sarah Patton Boyle, U.S. civil rights activist and author. The Desegregated Heart, part 1, ch. 15 (1962)