3 ms·

The leakiest incentive is that the FDA gets in a huge amount of trouble if it lets through a drug that has unforseen negative side effects, but faces essentiall

The leakiest incentive is that the FDA gets in a huge amount of trouble if it lets through a drug that has unforseen negative side effects, but faces essentially zero consequences for holding up the approval of a worthwhile drug indefinitely, and requiring billions of dollars to be spent on its development.

anigbrowl 10y ago
What wonder drugs are on the market in other developed countries that US consumers are dying to get hold of? If this is a big problem it should be easy to name several.
- snrplfth 10y ago
  I didn't say they were on the market in other developed countries, since the drug approval bodies in those countries tend to face similar incentives. My point is that the process which requires drugs, even many existing generics, to go through extremely extensive testing for each possible application, is a problem because it means that only very large companies have the financial wherewhithal to get drugs through approval, and there is a strong incentive to focus on drugs which will be big sellers in a large market, rather than drugs for smaller markets. The trouble is that one does not see what was prevented from existing.
  - anigbrowl 10y ago
    Then I'd say the primary problem is to reduce the cost of an access to clinical trials or improved flexibility in the trial requirements proportional to the size and plight of the patient population. The 'similar incentives' you mention are wanting to avoid public-health crises of the sort we have experienced many times in the past. The trouble is that one does not see what was prevented from existing. Opportunity cost is a basic fact of economics. It seems to me that people put a higher premium on reliability than novelty in this sphere; that is to say, the cost to society of people dying from terminal disease is less than that of people dying unexpectedly after treatment for less deadly conditions. Also, your statement assumes those cures will never be discoverable.
daveguy 10y ago
> but faces essentially zero consequences for holding up the approval of a worthwhile drug indefinitely, and requiring billions of dollars to be spent on its development. The FDA does not hold up worthwhile drugs indefinitely. It does take time and money to scientifically confirm the safety and efficacy of drugs. The whole point is to make sure drugs are safe and effective -- the FDA does a pretty good job of that. Sure the pharma industry would have you believe it's just a bunch of pointless roadblocks. I would like for you to point out a regulation or requirement of the FDA that you think should be eliminated.
- snrplfth 10y ago
  The problem is that the pharma industry wouldn't have you believe it's a bunch of pointless roadblocks. The pharmaceutical industry, as currently constituted, generally thinks the FDA's system is great, because it means that not only are smaller, novel, and foreign competitors easily closed out of the market, but that they have long-term sole approval for their drugs. The large drug companies find this an extremely comfortable relationship - it's stable, predictable, and they are well-practiced at it. I think that it's not a problem to have an FDA which reviews and approves drugs, and even one which determines which drugs are qualified for Medicaid/Medicare payments. But what I would like to see is an "opt-out" system, where patients could sign a waiver declaring that they are aware that the drugs they would like have not been approved by the FDA and that they may be hazardous, to access otherwise-unapproved drugs. I think there are genuine costs to the current system that are too commonly dismissed: http://www.jpands.org/vol15no4/kazman.pdf http://www.jpands.org/vol15no4/kazman.pdf I'm not saying "abolish the FDA", I'm just saying "allow people to bypass its judgement if they really feel that they have to".

anigbrowl 10y ago

What wonder drugs are on the market in other developed countries that US consumers are dying to get hold of? If this is a big problem it should be easy to name several.

snrplfth 10y ago
I didn't say they were on the market in other developed countries, since the drug approval bodies in those countries tend to face similar incentives. My point is that the process which requires drugs, even many existing generics, to go through extremely extensive testing for each possible application, is a problem because it means that only very large companies have the financial wherewhithal to get drugs through approval, and there is a strong incentive to focus on drugs which will be big sellers in a large market, rather than drugs for smaller markets. The trouble is that one does not see what was prevented from existing.
- anigbrowl 10y ago
  Then I'd say the primary problem is to reduce the cost of an access to clinical trials or improved flexibility in the trial requirements proportional to the size and plight of the patient population. The 'similar incentives' you mention are wanting to avoid public-health crises of the sort we have experienced many times in the past. The trouble is that one does not see what was prevented from existing. Opportunity cost is a basic fact of economics. It seems to me that people put a higher premium on reliability than novelty in this sphere; that is to say, the cost to society of people dying from terminal disease is less than that of people dying unexpectedly after treatment for less deadly conditions. Also, your statement assumes those cures will never be discoverable.

daveguy 10y ago

> but faces essentially zero consequences for holding up the approval of a worthwhile drug indefinitely, and requiring billions of dollars to be spent on its development. The FDA does not hold up worthwhile drugs indefinitely. It does take time and money to scientifically confirm the safety and efficacy of drugs. The whole point is to make sure drugs are safe and effective -- the FDA does a pretty good job of that. Sure the pharma industry would have you believe it's just a bunch of pointless roadblocks. I would like for you to point out a regulation or requirement of the FDA that you think should be eliminated.

snrplfth 10y ago
The problem is that the pharma industry wouldn't have you believe it's a bunch of pointless roadblocks. The pharmaceutical industry, as currently constituted, generally thinks the FDA's system is great, because it means that not only are smaller, novel, and foreign competitors easily closed out of the market, but that they have long-term sole approval for their drugs. The large drug companies find this an extremely comfortable relationship - it's stable, predictable, and they are well-practiced at it. I think that it's not a problem to have an FDA which reviews and approves drugs, and even one which determines which drugs are qualified for Medicaid/Medicare payments. But what I would like to see is an "opt-out" system, where patients could sign a waiver declaring that they are aware that the drugs they would like have not been approved by the FDA and that they may be hazardous, to access otherwise-unapproved drugs. I think there are genuine costs to the current system that are too commonly dismissed: http://www.jpands.org/vol15no4/kazman.pdf http://www.jpands.org/vol15no4/kazman.pdf I'm not saying "abolish the FDA", I'm just saying "allow people to bypass its judgement if they really feel that they have to".