www.fdanews.com/articles/149213-pharma-blog-watch
Pharma Blog Watch
September 5, 2012
Speed or Safety? (Drug Wonks blog)
Thomas J. Moore and Curt D. Furberg, in a new Journal of the American Medical Association article, accuse the FDA of compromising safety for speed. As usual, blogger Peter Pitts writes, CDER Director Janet Woodcock places the matter in the appropriate perspective. “I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,” Woodcock said. “The cancer community in particular says we haven’t used accelerated approvals enough.” There is no truly safe drug. “Here’s the truth,” Pitts writes. “There is no such thing as a ‘safe’ drug. It’s the patient who must understand the risks required to achieve the benefit.”
Thomas J. Moore and Curt D. Furberg, in a new Journal of the American Medical Association article, accuse the FDA of compromising safety for speed. As usual, blogger Peter Pitts writes, CDER Director Janet Woodcock places the matter in the appropriate perspective. “I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,” Woodcock said. “The cancer community in particular says we haven’t used accelerated approvals enough.” There is no truly safe drug. “Here’s the truth,” Pitts writes. “There is no such thing as a ‘safe’ drug. It’s the patient who must understand the risks required to achieve the benefit.”