My read of the article makes this sound more like a natural failure than a regulatory one. The anti-venoms are very expensive to make and very rarely needed.

I see no reason that these drugs should get a pass on FDA testing that other drugs are held to, so it doesn't seem like a regulatory failure. It seems like some body acting for the general good (ie, government or nonprofit, maybe some life/health insurance?) should pay for the FDA trials to help get the alternative drugs to market.

Fascinating. I had no idea that government regulation is the force which drives companies to stop manufacturing products which are expensive to manufacture and for which there's little demand in the market. You've truly opened my eyes to this hitherto-unseen lurking evil.