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FDA Debate: Is Agency Really Doing Its Job?

Dr.Andrew von Eschenbach
AP
Dr.Andrew von Eschenbach

In an editorial today,USA Today calls on the Food and Drug Administration to let dying patients get quicker, easier access to promising, potentially lifesaving or life-extending, developmental drugs.The paper argues that thousands of people in "dire circumstances" deserve "the chance to take a last-ditch gamble".

And in a rare public forum (for example, I haven't interviewed him in nearly a year-and-a-half), FDA Commissioner Dr. Andrew von Eschenbach writes the counterpoint "opposing view" piece: "As a two-time cancer survivor and a cancer specialist, I have witnessed patients struggle to find a solution for their disease and place their hope in an experimental drug. There is, and always must be, a pathway for such options. Nonetheless, allowing mass marketing and promotion of unproven therapies would have serious consequences: false hope and lack of real medical progress that could ultimately lead to control and cure of devastating illnesses."

The FDA is coming under more media and analyst scrutiny regarding its recent drug approval record and the agency is the target of an ongoing protest by investors and patient advocates over its delay in approving Dendreon's Provenge for prostate cancer. In addition, The Wall Street Journal in recent weeks has published two op-ed pieces about the situation. I wonder if the gathering critical mass is what prompted Dr. von Eschenbach to pen the item in today's USA Today.

Questions? Comments? Pharma@cnbc.com