To speed access to compassionate use, look beyond the FDA

Health Affairs Blog

10 August 2017 - In mid-July, the nonpartisan research arm of the federal government, the Government Accountability Office, released its long-awaited verdict on how the FDA is handling compassionate use. 

As anyone who saw Dallas Buyers Club knows, compassionate use (also known as pre-approval access and expanded access) is when a drug company allows a patient who has no other treatment options to try a drug that is still in development and not FDA approved for use or sale. 

These patients are generally too sick to participate in a clinical trial—which has inclusion and exclusion criteria to try to keep the trial data from getting too “messy”—but if their physician, the drug company, the FDA, and their physician’s institution (in that order) all permit the effort, they can try these drugs in development through compassionate use.

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Michael Wonder

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Michael Wonder