“Some members of the advisory committee pointed to a downside in today’s decision to strip the drug of its breast cancer label: This could undermine the accelerated approval process under which Avastin first got FDA’s blessing. Accelerated approval is a way to get drugs to the sickest patients more quickly, with less clinical data. It’s virtually unheard of for FDA to reverse such an approval. In this case, FDA did so, agency officials said, after subsequent studies showed that the benefit was much less than initially thought.”
I’ve been following pharmacoepidemiology quite a lot lately, mostly because one of the product we sell (and I market) is used to look the effectiveness of drugs, help understand if there might be some off-label uses, and help drugs like Avastin succeed in their selected market and others that might also work. Of course, I’m now going to see how this deregulation can be avoided with better data analysis.
