3 ms·

Greed? It's not like the drug companies are writing the Government a $100 million dollar check (which, you realize, is a pittance to the US Government, who's bu

by Sebguer 10y ago

Greed? It's not like the drug companies are writing the Government a $100 million dollar check (which, you realize, is a pittance to the US Government, who's budget is 3.8 TRILLION DOLLARS) Yes, there are a lot of heavy, potentially onerous requirements to releasing a drug. Sometimes these requirements result in drugs taking a long time to be publicly available. But the goal of this process is public safety, not making a quick buck.

goodells 10y ago
Government 'greed' may not be the best way to put it, but there is something there. This extremely high barrier to entry may not be completely necessary, and in some cases may be interpreted as deliberate suppression of competition effected by vested interests in the pharmaceutical and healthcare industries. If such a product can be proven safe using the same active ingredient and a comparable delivery mechanism, it shouldn't require millions of dollars to be approved.
- manicdee 10y ago
  The regulation is necessary because of the number of bad actors in the industry. From experimenting on people under the guise of vaccination programs through cherry picking of results, drug and technology companies have proven time and time again that they can not be trusted to put human welfare ahead of profits. How do you prove a new product from a hostile industry safe, without having regulations covering the types of tests and acceptable reporting necessary?
  - jacobr1 10y ago
    The problem isn't "should we have regulation at all," but rather what is the right level of regulation. It is quite possible that the current burden of proof is too high in many cases. If drugs were made more broadly available sooner, it would likely save many lives. But also it would also likely cost some. Do we currently use the correct threshold? There is certainly evidence that since regulatory bodies get tons of flack for letting through bad drugs, but aren't imposed on that much for slowing down the process, they incline to being risk adverse. We also have evidence of outcomes in Europe where the regulatory regimes differ and seem to approve things faster with outcomes that aren't generally worse than the US. I highly doubt we have the optimal regulatory solution at present and could do much better. And if anything we have standards that are too high.
    - daurnimator 10y ago
      Perhaps it's a situation where there is no outcome where the barrier to entry is too high for bad actors while simultaneously being low for good actors. The current solution seems to be to increase the barrier until the bad actors are gone; as this means there is less finger pointing. Going the other way would seem to take active effort from a political representative, and the outcome will end in deaths directly attributable to them.... which would be career suicide.
- fredsmith220 10y ago
  The phrase you're looking for is "Regulatory Capture"
- rayiner 10y ago
  There are accelerated approval processes for precisely what you're describing. Section 505(b)(2), for example, allows an applicant to rely on studies conducted for a previously-approved drug with the same active ingredient. And of course the whole ANDA generic approval process.
- Thriptic 10y ago
  Part of the issue is the incentive system at work. The FDA isn't really rewarded for getting a drug to market quickly, but they are punished politically when they approve a drug that is later found to have problems. This means that they are incentivized to be cautious, sometimes excessively so.
red_blobs 10y ago
Okay, then expect expensive drugs for decades when it costs billions in R and D and the drug companies need to recoup the
red_blobs 10y ago
Okay, then expect expensive drugs for decades when it costs billions in R and D and the drug companies need to recoup the costs (in addition to the red-tape involved in releasing the drugs). Many countries with cheap drugs never had to pay all of the research and development costs. If it's not government greed, it's government ineptness and the inability to understand how the market actually works. The generic company in this article, for instance, never had to pay any R&D costs for the proprietary epipen applicator and can easily charge a much lower amount of money for a generic version (which is different). The high cost of FDA approval also creates monopolies, because it's very difficult to get anything to market. To get better and cheaper drugs, we need to change this at the government level.

by Sebguer 10y ago

goodells 10y ago

Government 'greed' may not be the best way to put it, but there is something there. This extremely high barrier to entry may not be completely necessary, and in some cases may be interpreted as deliberate suppression of competition effected by vested interests in the pharmaceutical and healthcare industries. If such a product can be proven safe using the same active ingredient and a comparable delivery mechanism, it shouldn't require millions of dollars to be approved.

manicdee 10y ago
The regulation is necessary because of the number of bad actors in the industry. From experimenting on people under the guise of vaccination programs through cherry picking of results, drug and technology companies have proven time and time again that they can not be trusted to put human welfare ahead of profits. How do you prove a new product from a hostile industry safe, without having regulations covering the types of tests and acceptable reporting necessary?
- jacobr1 10y ago
  The problem isn't "should we have regulation at all," but rather what is the right level of regulation. It is quite possible that the current burden of proof is too high in many cases. If drugs were made more broadly available sooner, it would likely save many lives. But also it would also likely cost some. Do we currently use the correct threshold? There is certainly evidence that since regulatory bodies get tons of flack for letting through bad drugs, but aren't imposed on that much for slowing down the process, they incline to being risk adverse. We also have evidence of outcomes in Europe where the regulatory regimes differ and seem to approve things faster with outcomes that aren't generally worse than the US. I highly doubt we have the optimal regulatory solution at present and could do much better. And if anything we have standards that are too high.
  - daurnimator 10y ago
    Perhaps it's a situation where there is no outcome where the barrier to entry is too high for bad actors while simultaneously being low for good actors. The current solution seems to be to increase the barrier until the bad actors are gone; as this means there is less finger pointing. Going the other way would seem to take active effort from a political representative, and the outcome will end in deaths directly attributable to them.... which would be career suicide.
fredsmith220 10y ago
The phrase you're looking for is "Regulatory Capture"
rayiner 10y ago
There are accelerated approval processes for precisely what you're describing. Section 505(b)(2), for example, allows an applicant to rely on studies conducted for a previously-approved drug with the same active ingredient. And of course the whole ANDA generic approval process.
Thriptic 10y ago
Part of the issue is the incentive system at work. The FDA isn't really rewarded for getting a drug to market quickly, but they are punished politically when they approve a drug that is later found to have problems. This means that they are incentivized to be cautious, sometimes excessively so.

red_blobs 10y ago

Okay, then expect expensive drugs for decades when it costs billions in R and D and the drug companies need to recoup the

red_blobs 10y ago

Okay, then expect expensive drugs for decades when it costs billions in R and D and the drug companies need to recoup the costs (in addition to the red-tape involved in releasing the drugs). Many countries with cheap drugs never had to pay all of the research and development costs. If it's not government greed, it's government ineptness and the inability to understand how the market actually works. The generic company in this article, for instance, never had to pay any R&D costs for the proprietary epipen applicator and can easily charge a much lower amount of money for a generic version (which is different). The high cost of FDA approval also creates monopolies, because it's very difficult to get anything to market. To get better and cheaper drugs, we need to change this at the government level.