"I guess we'll all find out how factual the author's words are."
We already know that the exact opposite of what the author claimed is true (as is usually the case with that particular author).
Compassionate use of an investigational drug (aka Expanded Access) requires pre-approval by FDA on a case-by-case basis and the outcomes need to be appended to the IND:
"The FDA must determine the following:
The patient (or patients) to be treated has a serious or life-threatening disease or condition. There is no comparable or satisfactory therapy to diagnose, monitor, or treat the disease or condition. The patient cannot get the medical product under another investigational medical product study or protocol. The possible benefits to the patient justify the possible risks of the treatment, and those possible risks are not unreasonable given the disease or condition to be treated. Providing the investigational medical product will not interfere with the clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access product. FDA will determine whether the expanded access request may proceed. If the investigational medical product treatment is not allowed to proceed, FDA will inform the licensed physician or the company (whoever submitted the request) of this decision. FDA will communicate what issues need to be resolved in order for treatment to move forward."
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