FDA clarifies when sponsors' expanded access policies need to be made public
When the Right to Try Act was born, regulatory critics relayed the inaccurate message that the FDA and its onerous regulations were getting in the way of providing very sick people with life-saving cures.
In reality, sponsors of an investigational drug (for various reasons) are usually the only barrier to what are often last-ditch efforts to find something/anything still under clinical trials to prolong a life. The FDA signs off on more than 99% of these requests, known as expanded access requests, but cannot compel a sponsor to provide expanded access to its drug.
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