While I can agree that jumping through hoops to meet regulations sucks, the cost of failure and the potential for unintended consequences justifies the high market entry costs. To be fair, the FDA is constantly making decisions (with regards to approval) that ethicists have struggled with for millenia. Furthermore, its not readily apparent what constitutes an effective drug in many cases due to the placebo effect.
For an example of the FDA's good work, if you have the chance, take a look at the FDA's 483 for the McNeil plant that recently got shut down (the children's Tylenol, Benadryl, etc. recall). Its kind of horrifying: http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORA...
Perhaps a more relevant example would be the case of United States v. Caputo (7th Cir. 2008). Caputo had gotten clearance to sell a small sterilizer of surgical equipment without tubes or hinges. His customers, being satisfied with that equipment, requested a larger sterilizer instrument that could sterilize equipment with tubes or hinges. Caputo, meaning well, and believing that the changes between the two equipments were trivial (as it would seem at first glance) produced what his customers requested and sold and marketed it. Turns out that one of the opthalmic instruments being sterilized had brass joints that reacted to the peracetic acid being used to sterilize. It resulted in numerous people being blinded. Of course, he later failed to report the cases of blindness to the FDA, which resulted in further problems. But I still believe that the point can be made that the possibility for unintended consequences and the high costs of mistakes justifies the high barrier to entry that the FDA imposes.
In the case of the snake antivenin, its a long process to produce antivenin in general. Its made by injecting a sheep or horse (older antivenins used horses, newer ones tend to use sheep) with the venom and then gathering and purifying the antivenin that the sheep or horse produces in response (Animal rights groups have historically protested in locations where antivenin is made). Hopefully the government or some public interest organization will fund further production of the antivenin, its unfortunate that antivenin is not more durable.
For an example of the FDA's good work, if you have the chance, take a look at the FDA's 483 for the McNeil plant that recently got shut down (the children's Tylenol, Benadryl, etc. recall). Its kind of horrifying: http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORA...
Perhaps a more relevant example would be the case of United States v. Caputo (7th Cir. 2008). Caputo had gotten clearance to sell a small sterilizer of surgical equipment without tubes or hinges. His customers, being satisfied with that equipment, requested a larger sterilizer instrument that could sterilize equipment with tubes or hinges. Caputo, meaning well, and believing that the changes between the two equipments were trivial (as it would seem at first glance) produced what his customers requested and sold and marketed it. Turns out that one of the opthalmic instruments being sterilized had brass joints that reacted to the peracetic acid being used to sterilize. It resulted in numerous people being blinded. Of course, he later failed to report the cases of blindness to the FDA, which resulted in further problems. But I still believe that the point can be made that the possibility for unintended consequences and the high costs of mistakes justifies the high barrier to entry that the FDA imposes.
In the case of the snake antivenin, its a long process to produce antivenin in general. Its made by injecting a sheep or horse (older antivenins used horses, newer ones tend to use sheep) with the venom and then gathering and purifying the antivenin that the sheep or horse produces in response (Animal rights groups have historically protested in locations where antivenin is made). Hopefully the government or some public interest organization will fund further production of the antivenin, its unfortunate that antivenin is not more durable.