Scott Gottlieb, MD, in a Forbes opinion, opines the Food and Drug Administration’s increasingly cautious approach to the approval of new medicines. Previously, the FDA rejected the testosterone patch Intrinsa and recommended against over-the-counter status for the cholesterol-lowering drug Mevacor. Now, the FDA’s Oncology Drug Advisory Committee (ODAC) may delay approval of new drugs.
Apparently, the chair of the FDA’s cancer drug advisory committee rejected the idea that cancer drugs should be allowed onto the market if they are reasonably safe and have some degree of effectiveness ("efficacy") with the understanding that oncologists will determine their value through routine use of the drug, as is now customary.
This doesn’t bode well for biotech companies working on cancer drugs, most of whom are already suffering from a high burn rate. Currently, the approval process can take as long as ten years and cost nearly half a billion dollars.
This begs the question: Shouldn’t patients who are dying have some say on the cost:benefit ratio they are willing to accept? As Dr. Gottlieb states, "A fresh crop of caution inside the FDA may keep the agency out of the news, but it won’t keep my cancer patients from dying."