What, does the FDA demand less expenditure on studies if the marketer of the drug only plans to charge a low price for it?
(That’s what your comment sounds like.)
Funding is an issue for all “orphan” diseases and syndromes.
The FDA committee makes a “cost versus benefit” decision implicitly and/or explicitly with all of its decisions.
AIDS activists, notably the recently deceased activist Spencer Cox, made their name by beating up FDA to waive the normal rules and approve half-baked drugs given the high death rates back in the 1980S.
CFS activists have been trying the same argument with the FDA based on the severe debilitation of CFS, in some cases leading to suicide. “A marginal drug is better than no drug” is the argument.
If FDA approved Ampligen, the hard-pressed US health “insurance” system, especially under Obamacare, might be required to reimburse the $25,000/year Ampligan treatment, as it has with expensive MS infusion drugs, for example. Cost IS a consideration in drug approvals.
In the case of the MS infusion drugs, the benefits were much clearer and the patients that would benefit could be identified with greater accuracy than CFS (no accuracy actually, in CFS it seems). So Ampligen failed both the cost and benefit sides of the cost/benefit analysis, except for the four members of the panel who still thought it did!