# FDA creates new drug safety board



## jjohnson (Apr 29, 2004)

Fortunately, for those of us here, the proposed office is considerably more watered-down and a good deal less independent than what some critics were clamoring for. Don't get me wrong, I'm not for lax oversight, but I do support the right of patients to make informed decisions about what level of risk is acceptable to them, as with Lotronex, a drug I have never used but support 100%. Under the proposed system, I don't think there should be any threat of the drug being pulled again (as might have been possible if the Office of Drug Safety had been taken out of CDER completely), undoing all the hard work of many people here and bringing back the nightmare of 2000, as well as raising possible threats to newer treatments that may carry some level of risk but that many people with this horrible disorder find acceptable. Anyway here is the article, complete with predictable grumbling from Dr. Wolfe, who mercifully isn't having his way.







http://www.newscientist.com/article.ns?id=dn7017


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