Perhaps those at the Food and Drug Administration (FDA) who are responsible for more delays in the approval of the drug Eteplirsen were inspired by the imaginative approach of their colleagues at the Department of Veterans Affairs, who compared the long delays in treating veterans to waiting in line at Walt Disney World. It is "the quality of the overall experience" that the VA says we should consider, not the time it takes. . . . [ full article ]
First, Do No Harm: A Few Simple Rules for the FDA
April 22, 2016
Top management recently changed at the Food and Drug Administration (FDA), with a new commissioner, Robert M. Califf, in the top spot. Therefore this is a good time to review the basic principles upon which the FDA should base its decisions.
The first principle is not that the FDA is in charge of American medicine but rather that patients and their physicians are in charge of their care.
From that follows "First, do no harm."
You and your physician should not have to ask the FDA for permission to use a medication. If you have a terminal illness, you should especially not have to ask the FDA for permission to live. Unfortunately current law says that you do. The U.S. Supreme Court has ruled that you must comply with that law. . . . [ full article ]
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