Health care is cheap; health care regulation is expensive crony capitalism.
Um... no. At least, not necessarily.
I worked for a blood bank for several years, and because blood banks by definition supply both pharmacologics (plasma fractions, IIRC) and biologics (practically everything else), they are subject to FDA regulation as defined in the CFR for those types of agents. My particular blood bank was under a consent decree with FDA for failing to follow those regulations in whole and/or in part, and that failure to follow can have real consequences for the patient -- accidental infections with things like CMV become a whole lot easier when your controls over CMV status labeling are lax, for example. In that case, an otherwise healthy adult might just get flu symptoms. In someone who is ill (or someone who is not yet an adult, or even an adolescent), which a recipient would generally be, the consequences can be significantly more dire.
Why does that matter?
It's truly amazing just how many corners blood banks like mine were willing to cut in the name of building product numbers, because ultimately, they're really just manufacturers pushing a product for maximum profit -- sure, any time we'd send letters to anyone we'd play up the non-profit jag and ask them to use their own stamps on the SAE we'd send them for their reply, but all management really ever cared about was pumping up profits. If the regulations weren't in place to cover things like labeling, it's a fair bet the manufacturers wouldn't bother to enact those policies on their own. If they're not held to a given standard, they won't expend the money to maintain that standard. Labelers, training, equipment, testing supplies, testing contracts, and other related recurring expenses are exactly the type of expenses management doesn't want to incur. Patient health really only matters if it could bring legal ramifications, and if there's no law being violated or regulatory standard in place, it's actually fairly easy for the manufacturers to get off scot-free -- even in a civil trial. Regulatory infractions come up in civil trials all the time.
Blood banks in particular demonstrated this fairly clearly in the early 1980's, when HIV started to show up on the scene. HIV itself wasn't immediately apparent, but a tremendous uptick in Hepatitis B cases was -- and at the time, the technology did indeed exist to test for that virus. Blood banks advised that testing for Hepatitis B was not acceptable... because of cost. Bayesian false positives didn't come into it. Faults with the general theory of testing didn't come into it. Fears of HIV infection didn't come into it (at least, at the testing phase). The reason blood banks didn't want to test for HepB was the cost to institute a testing program, and it was FDA's mandate that ultimately got them to start testing and getting the bad blood out of the supply. (It was also FDA's regulation that pegged Abbott Laboratories, I think, with bad HepB testing supplies... here again, without regulation, nothing would've been done, because nothing would've been illegal.)
The expense of regulation isn't a 100% honest deal, because there are always going to be corrupt regulators. At the same time, I would much rather have legitimate regulators working from a pool that includes a few corrupt ones, and dealing with that, than to have the corporate health care industries strictly regulate themselves, because as has been proven numerous times (blood banks, contaminated food cases, contaminated drug cases, improperly tested drug cases, I could go on...), they will do no such thing with that inherent conflict of interest.