Is a rising tide of risk aversion at a post-Vioxx FDA behind the agency's anemic approval record [1]? No way, say the FDA's Janet Woodcock (photo [2]). It's all about the science. And the science, she insists, is pointing to troubling indicators about some of these new drugs.
"We have a different story from the companies," Woodcock told the Financial Times. "We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions."
The length and size of clinical trials are growing, Woodcock acknowledges, but that's because regulators know more about what they need by way of data. And new efforts to standardize trials--à la Henry Ford--should help matters. "We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it."
- check out the article [3] in the Financial Times
Related Articles:
2007 FDA approvals. Report [1]
More mixed messages from the FDA. Report [4]
FDA: Hyper-cautious or simply vigilant? Report [5]
Links:
[1] http://www.fiercebiotech.com/special-reports/2007-fda-approvals
[2] http://www.fiercebiotech.com/pages/janet-woodcock
[3] http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html
[4] http://www.fiercebiotech.com/story/more-mixed-messages-from-the-fda/2008-01-02?utm_medium=nl&utm_source=linkhttp://www.fiercebiotech.com/story/more-mixed-messages-from-the-fda/2008-01-02?utm_medium=nl&utm_source=link
[5] http://www.fiercepharma.com/story/fda-hyper-cautious-or-simply-vigilant/2007-12-21?utm_medium=nl&utm_source=link