To judge the FDA's recent revocation of approval for Avastin for breast cancer, let's go back to basics. What is the job of the FDA?
To find out, you need only to look at the FDA's home page, where the tag line is "Protecting and Promoting Your Health." (Their italics)
As an agency within the US Department of Health and Human Resources, the FDA is charged with many responsibilities. A limited list includes assuring the safety, effectiveness, and security of human drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements and products that give off radiation.
The FDA is also responsible for helping to speed product innovations and helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health.
The FDA walks a tightrope: If the approval process is lax, they put patients at risk. But if it's too stringent, they deprive patients of desperately needed therapies.
If after FDA approval a therapy is found to cause serious problems, patients often blame the FDA. If patients are denied therapies they want, the FDA is blamed.
To see where problems may lie and if we can do better, in my next post, we'll look briefly at what's involved in obtaining approval.
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