[url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.104]'Emergency use' clause[/url] -- you're looking at point (c), though the rest should give you an idea of the context of these sorts of exceptions and what they mean.

'Compassionate use' is not governed by a specific code (that I've found anyway). [url=http://www.research.ucsf.edu/chr/guide/chrEmerUse.asp]This UCSF page[/url] breaks down some of the different categories and respective criteria for 'compassionate use,' and here's the one that (I think) applies here:

[quote=UCSF]Treatment INDs or Individual Patient Access to Investigational Drugs/Devices for Serious Diseases: [i]These mechanisms are primarily intended to give seriously ill patients access to experimental drugs or devices where no comparable or satisfactory alternative treatment is available.[/i] Although the test article sponsor is expected to continue conventional clinical trials and pursue marketing approvals with due diligence, expanded access studies involve systematic use of experimental treatments, and , with very rare exceptions, [b]require the same review and approval as research, including both CHR approval and FDA approval in the form of an IDE (medical device) or an IND (drug/biologic).[/b][/quote]

It's still an approval process, much like getting a drug cleared by the FDA in the first place, only now you're putting your product up [i]before[/i] it's actually ready to go, which becomes a [u]huge[/u] consideration when the FDA is making its judgments on final approvals and shit. In other words, you've got a really hungry guy who's going to starve to death unless you feed him right this second, so you give him your undercooked noodles and he throws up. Now when you want to open your restaurant and sell noodles, that incident becomes.... bad. All you were trying to do was the right thing, and you screwed *everybody* out of getting delicious noodles.

Terrible analogy. Let's get back to data.

[quote]Consequences of Noncompliance with Federal Regulations

As mentioned in the “Brief Overview” of these guidelines, the University and the FDA wish to support a physician's obligation to treat a seriously ill patient with all available modalities. If, however, the strict emergency use requirements are not met, both the physician and the institution may suffer strong sanctions.

•	Physician noncompliance may result in termination or suspension from treating patients in any and all FDA-regulated studies.
•	If the institution fails to provide guidance to physicians and to establish clear procedures, the institution's ability to conduct FDA-regulated research may be restricted.[/quote]

TLDR: In the interest of public health and safety, we maintain a boogeyman on a leash called the FDA, which gobbles up all the harmful things and keeps us safe. But it is a monster we've got here. Those who don't want to get eaten, aren't greedy -- they're smart. Unfortunately our zeal for safety has created a barrier by which the smart course of action is not the one that helps people in the short term. I don't know if there is any legal approach that gets this kid the help he needs, and I can identify with that a little, with my struggles lately.... I mean you could steal the drug, and then Chimerix is off the hook and you can feed the kid his pills and maybe he gets better. That's a way to go. Weeee're not talking about data anymore, which means it's time for MDK to shut up and find a coloring book. Carry on. If I get a chance I'll send them a pizza.... There's only so much I can do.