4 ms·

While it's done a lot of good for making things safe to eat and is a necessary public service I'm going to have to say that currently: ...The FDA sucks... You

by fjabre 16y ago

While it's done a lot of good for making things safe to eat and is a necessary public service I'm going to have to say that currently: ...The FDA sucks... You need millions in legal/preparation fees just to get your foot in the door and the level of bureaucratic bullshit you have to deal with still blows my mind. My company has had a lot of experience in this sorry to say. Again. Going to reiterate here: The FDA sucks and needs to be completely overhauled. Lots of PhDs and government bureaucrats spending too much time behind a desk with no real world experience and dictating arcane rules to the rest of us - that's the FDA I know.

Retric 16y ago
I don't think the FDA is the real problem on this one. There is a known treatment whose patents have expired, however for now nobody is willing to manufacture it.
- atlbeer 16y ago
  It's just not profitable to manufacture the currently known solutions. If someone discovers a new, better antivenin you would still have to spend millions of dollars and wait years to pass the FDA guidelines. That alone probably destroys the profitability margins of most discoverable solutions due to the small demand.
  - deleted 16y ago
    [deleted]
fnid2 16y ago
You know, when you boil it all down, most things in life are about the approval process. Money has become the defacto standard for approval. If the FDA requires millions of dollars to be approved, then the people, law, and pharmacies believe that organization getting approval must be approve worthy. If you are a guy in a shed with a couple thousand bucks and a cancer cure, ... hmm... you're just a guy in a shed. If you were smart enough to cure cancer, obviously you'd have more than a couple thousand bucks -- right? So that's how society works. A series of gate keepers who have become persuasive enough to acquire "convincing wealth". Wealth is all you need to convince others that whatever you have and whatever you may have in the future is worth buying into, either in thought, or as a product. Many times, this convincing is as easy as an advertisement on television or some clever lawyers who can figure out that all you have to do is change the name of your product and market it to another segment to extend your patent.
- infinite8s 16y ago
  You do know why it costs so much to have a drug approved? Running 3 phase clinical trials (the last 2 with people) aren't cheap.
go37pi 16y ago
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/ORAElectronicReadingRoom/UCM210772.pdf 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.

by fjabre 16y ago

Retric 16y ago

I don't think the FDA is the real problem on this one. There is a known treatment whose patents have expired, however for now nobody is willing to manufacture it.

atlbeer 16y ago
It's just not profitable to manufacture the currently known solutions. If someone discovers a new, better antivenin you would still have to spend millions of dollars and wait years to pass the FDA guidelines. That alone probably destroys the profitability margins of most discoverable solutions due to the small demand.
- deleted 16y ago
  [deleted]

fnid2 16y ago

You know, when you boil it all down, most things in life are about the approval process. Money has become the defacto standard for approval. If the FDA requires millions of dollars to be approved, then the people, law, and pharmacies believe that organization getting approval must be approve worthy. If you are a guy in a shed with a couple thousand bucks and a cancer cure, ... hmm... you're just a guy in a shed. If you were smart enough to cure cancer, obviously you'd have more than a couple thousand bucks -- right? So that's how society works. A series of gate keepers who have become persuasive enough to acquire "convincing wealth". Wealth is all you need to convince others that whatever you have and whatever you may have in the future is worth buying into, either in thought, or as a product. Many times, this convincing is as easy as an advertisement on television or some clever lawyers who can figure out that all you have to do is change the name of your product and market it to another segment to extend your patent.

infinite8s 16y ago
You do know why it costs so much to have a drug approved? Running 3 phase clinical trials (the last 2 with people) aren't cheap.

go37pi 16y ago

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/ORAElectronicReadingRoom/UCM210772.pdf 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.