Why the FDA should take more chances on riskier drugs
October 6, 2015
Imagine you are diagnosed tomorrow with pancreatic cancer. Odds are you have a 6 percent chance of surviving more than five years. But if you had prostate cancer, a disease with many more treatment options, the likelihood of being alive in five years skyrockets to 99 percent.
But the FDA has not adjusted the drug approval process to raise the possibility of bringing life-changing drugs to patients. Instead, the agency will not approve a drug if there is more than a 2.5 percent chance that it doesn’t work — no matter which disease or how poor the prognosis. And in a new paper, an MIT professor takes the FDA to task for not being more flexible
No Comment