Red Tape Roadblocks - Two Physicians Can Barely Get P.A. Drug for Very Sick Child

In an essay in Annals of INternal Medicine, dated 1/21/2025, two physicians can barely, after weeks of effort, get a key drug for their very sick child.  The denials were repetitive and had to do with the exact verbiage on the FDA label.

https://www.acpjournals.org/doi/10.7326/ANNALS-24-02781

One connection I made would be when a specialty drug requires "XYZ" diagnostic test on the labeling, but an innovator lab has an LDT that provides superior performance, or a new generation of technology, but is not on-label.