Sarcoma Foundation calls for radical change in FDA review process

Mark Thornton, a former medical officer at the FDA and current president of the Sarcoma Foundation of America, uses the recent Provenge approval to illustrate why the FDA needs to reverse its position on the cancer drug Mepact. Back in 2007 the FDA decided that both Provenge and Mepact should go back to the clinic for a new study. Dendreon was able to afford that because it was pursuing a mega-blockbuster approval for prostate cancer. But the developers of Mepact were essentially...