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:
“If women’s role in life is limited solely to housewife/mother, it clearly ends when she can no longer bear more children and the children she has borne leave home.”
—Betty Friedan (20th century)
“All of the assumptions once made about a parent’s role have been undercut by the specialists. The psychiatric specialists, the psychological specialists, the educational specialists, all have mystified child development. They have fostered the idea that understanding children and promoting their intellectual well-being is too complex for mothers and requires the intervention of experts.”
—Elaine Heffner (20th century)
“Placing the extraordinary at the center of the ordinary, as realism does, is a great comfort to us stay-at-homes.”
—Mason Cooley (b. 1927)
“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)
“We hold these truths to be sacred and undeniable; that all men are created equal and independent, that from that equal creation they derive rights inherent and inalienable, among which are the preservation of life, and liberty, and the pursuit of happiness.”
—Thomas Jefferson (1743–1826)