No, says Andrew von Eschenbach, it's not business-as-usual at the FDA. A thousand times no. The agency commish got peeved during an appearance at the American Enterprise Institute when someone suggested that appointing Janet Woodcock (photo [1]) to her former post at the top of CDER [2] was a return to the "old ways" at the agency. Au contraire, he said. She's "going back as a very, very strong change agent," he responded.
Is von Eschenbach worried that folks inside the FDA are misinterpreting his choice of Woodcock? He told the audience at AEI that he'd been "emphatic" about explaining his view on Woodcock's role: that she will create a CDER "nothing like the CDER that she left." He may also, In Vivo points out, be worried about his legacy at the agency. And he could be sensitive to charges that Woodcock can't be much of a change agent if she's a lame duck with only a few months to serve before a new president might bring in his or her own people into the FDA. Or maybe he saw the question a veiled criticism of his own leadership. Which, given all the fires [3] FDA is trying to put out these days, might be understandable.
- see the item [4] at In Vivo
Related Articles:
FDA's Woodcock handed back the reins at CDER. Report [2]
FDA taps new-yet-old drug chief. Report [5]
The FDA: Caught between a rock and a hard place. Report [6]
FDA moves to allay drug-import fears. Report [7]
FDA can't guarantee drug safety. Report [3]
Links:
[1] http://www.fiercebiotech.com/pages/janet-woodcock
[2] http://www.fiercebiotech.com/story/fda-s-woodcock-handed-back-the-reins-at-cder/2008-03-11?utm_medium=rss&utm_source=rss
[3] http://www.fiercepharma.com/story/fda-cant-guarantee-drug-safety/2007-11-02
[4] http://invivoblog.blogspot.com/2008/03/fdas-janet-woodcock-change-agent.html
[5] http://www.fiercepharma.com/story/fda-taps-new-yet-old-drug-chief/2007-09-24
[6] http://www.fiercebiotech.com/story/the-fda-caught-between-a-rock-and-a-hard-place/2007-11-09?utm_medium=nl&utm_source=link
[7] http://www.fiercepharma.com/story/fda-moves-to-allay-drug-import-fears/2008-03-17?utm_medium=rss&utm_source=rss