What should be the role of government in regulating pharmaceuticals and medical devices?
It’s common for critics to refer to the monetary costs to pharmaceutical companies that result from FDA’s long review times and rejection of promising new drugs. However, the far more important social cost of this agency risk aversion is often prolonged exposure by patients to disease, and sometimes death. Different patients will have vastly different tolerances for risk. While some would willingly forgo a promising new treatment when it poses even a remote risk of injury, others would be willing to use a highly risky new product knowing that it poses a substantial health risk. Unfortunately, while individual patients and their doctors can choose not to use approved drugs and devices that are known to have certain safety risks, patients are denied the choice to take a calculated risk with unapproved products. Unfortunately, this problem is inevitable in a government-managed safety agency because the way in which FDA balances the risks and benefits of new medicines will necessarily be i
