The FDA tries to practice medicine

Scott Gottlieb explains the folly of this:

When it comes to trying to manage drug risks and encourage safe prescribing, the FDA has plenty of reason to worry about how drugs get used. Many practitioners have a hard time explaining remote risks to their patients, and many patients a harder time understanding them. But the FDA can’t rationalize the diversity of peoples’ medical decision-making or the fact that some doctors, and patients, will simply choose to reject the agency’s medical practice advice or its computations when benefits justify certain risks.

Nor will any amount of regulation on how medicines are used defuse the risk that comes from medical care, or the uncertainty that inevitably lingers around new treatments. When it comes to medical practice, the agency’s job isn’t to find reasons to keep effective drugs from patients by actively managing prescribing decisions, but to surface obtainable information about risks and benefits so that patients can make informed choices for themselves.

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