5 ms·

Okay, this is a serious question. We just saw a report about how the SEC is too close with banks, and this shows the FDA not doing a good job regulating drug c

Okay, this is a serious question. We just saw a report about how the SEC is too close with banks, and this shows the FDA not doing a good job regulating drug companies. Can someone point to a good US regulatory agency? Like one that operates well, isn't scared to use it's powers aggressively, and so on? The closest I can think of is the Justice Department going after voter surpression.

tokenadult 12y ago
Regulatory capture happens to every regulatory agency, as a general rule. Hiring zealous staff who want to maintain the mission of the regulatory agency is not easy to do. http://faculty.haas.berkeley.edu/dalbo/Regulatory_Capture_Published.pdf http://faculty.haas.berkeley.edu/dalbo/Regulatory_Capture_Pu... http://www.tobinproject.org/books-papers/preventing-capture http://www.tobinproject.org/books-papers/preventing-capture
- epicureanideal 12y ago
  Perhaps the regulators should be rewarded with the kind of money that they'd never need to work again if they uncover significant violations, and the company should be fined a similar amount and shut down, with involved people put in prison? Seems like a solution. Also, you'd get a lot of very zealous people applying for those jobs. Heck, you could probably quadruple the inspection teams just with people willing to take low salary and treat it like playing the lottery.
  - zaroth 12y ago
    You do see the occasional case like Thalidomide, which is an amazing story of how Dr. Kelsey saved Americans from a very dangerous drug (prescribed for morning sickness, but caused terrible birth defects) which had a hand in transforming the FDA into the agency it is today. She was awarded the President's Award for Distinguished Federal Civilian Service, but I don't know about any cash windfall for doing such great work. Doctors and regulators in the FDA who protect the public from these drugs / drug companies are heroes. Perhaps it's not just the whistle blowers who should be getting 1/3rd of the settlement, but another portion should be set aside for performance awards for key people who made the case. Frankly though $500m wasn't enough. $5b would have properly shuttered this rotten steaming pile of a company.
    - CaptainZapp 12y ago
      While the consequences where certainly devastating don't be so fast to demonize Thalidomide. It's currently having a comeback and showing huge promise for cancer treatment: http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/thalidomide/art-20046534 http://www.mayoclinic.org/diseases-conditions/cancer/in-dept...
      - zaroth 12y ago
        It wasn't my intention to demonize thalidomide, or any of its many derivatives. You're right it's an effective (although very expensive) cancer treatment. At least a prescription now comes with a strict program to try to prevent exposing any fetuses. A far cry from a treatment for morning sickness. I can't get over the audacity of Gruenenthal (the German company who sold it). At least they finally got around to apologizing: http://www.bbc.com/news/health-19443910 http://www.bbc.com/news/health-19443910
- rurounijones 12y ago
  I am waiting for someone to pour out the cons here. But why not align incentives with expertise. Allow companies to test others' products, if they find serious problems then any fines resulting from a resulting FDA investigation are split between the govt and the company that found the issues. With generics there cannot be that much "This is a trade secret" since it is already in the open. I am sure they would be falling over each other to cripple the competition. Fire away.
  - lsiebert 12y ago
    Then you are shifting regulation to cover testing for collusion. I think one of the issues is that fines need to be huge, penalties painful, and decisions punishing to companies who get caught doing wrong.
    - a3n 12y ago
      CEOs need to be held responsible in the same way that Navy Captains are held responsible: they're responsible for everything that happens under their command. If they don't govern to prevent this, then they need the probability of jail and ending their careers. "Accountability" is paraded around a lot these days when dressing up a commpany in buzzwords. Our employees are accountable. I'm accountable. You're accountable. Starting sending CEOs and CXXs to jail, and it will stop.
MichaelGG 12y ago
I dunno but doesn't the FAA do a fairly good job? I suppose failures in air flight result in obvious, immediate, disasters so it's a bit easier to keep everyone accountable. I am pretty surprised that this Indian company got away with so much and just kept going. What did the FDA have to lose? Was this big in the mainstream news?
- karlkatzke 12y ago
  The FAA does a pretty good job, but internally they treat their employees pretty poorly, which in turn results in quite a bit of slip. You just don't always see it because it's caught by employees who ARE invested in their careers and in flight safety in general.
- lmm 12y ago
  There was a story here not so long ago about how the FAA relies on voluntary reporting of near misses, and so fail to act before an outright disaster occurs.
wpietri 12y ago
I've always had respect for the FDIC. Its former director, Sheila Bair, wrote a good book about the 2008 financial crash, "Bull By The Horns", and in there she has a lot to say about what makes for good regulation. I think one the problems the US has had in the last couple decades is a lot more talk along the lines of "government isn't the solution, government is the problem". This can be a useful critique in particular instances. But when it's a general slogan of people in charge of government, it becomes a self-fulfilling prophecy.
kjs3 12y ago
The article is about an Indian drug company operating in India. Why the specious attempt to make this about the US?

tokenadult 12y ago

Regulatory capture happens to every regulatory agency, as a general rule. Hiring zealous staff who want to maintain the mission of the regulatory agency is not easy to do. http://faculty.haas.berkeley.edu/dalbo/Regulatory_Capture_Published.pdf http://faculty.haas.berkeley.edu/dalbo/Regulatory_Capture_Pu... http://www.tobinproject.org/books-papers/preventing-capture http://www.tobinproject.org/books-papers/preventing-capture

epicureanideal 12y ago
Perhaps the regulators should be rewarded with the kind of money that they'd never need to work again if they uncover significant violations, and the company should be fined a similar amount and shut down, with involved people put in prison? Seems like a solution. Also, you'd get a lot of very zealous people applying for those jobs. Heck, you could probably quadruple the inspection teams just with people willing to take low salary and treat it like playing the lottery.
- zaroth 12y ago
  You do see the occasional case like Thalidomide, which is an amazing story of how Dr. Kelsey saved Americans from a very dangerous drug (prescribed for morning sickness, but caused terrible birth defects) which had a hand in transforming the FDA into the agency it is today. She was awarded the President's Award for Distinguished Federal Civilian Service, but I don't know about any cash windfall for doing such great work. Doctors and regulators in the FDA who protect the public from these drugs / drug companies are heroes. Perhaps it's not just the whistle blowers who should be getting 1/3rd of the settlement, but another portion should be set aside for performance awards for key people who made the case. Frankly though $500m wasn't enough. $5b would have properly shuttered this rotten steaming pile of a company.
  - CaptainZapp 12y ago
    While the consequences where certainly devastating don't be so fast to demonize Thalidomide. It's currently having a comeback and showing huge promise for cancer treatment: http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/thalidomide/art-20046534 http://www.mayoclinic.org/diseases-conditions/cancer/in-dept...
    - zaroth 12y ago
      It wasn't my intention to demonize thalidomide, or any of its many derivatives. You're right it's an effective (although very expensive) cancer treatment. At least a prescription now comes with a strict program to try to prevent exposing any fetuses. A far cry from a treatment for morning sickness. I can't get over the audacity of Gruenenthal (the German company who sold it). At least they finally got around to apologizing: http://www.bbc.com/news/health-19443910 http://www.bbc.com/news/health-19443910
rurounijones 12y ago
I am waiting for someone to pour out the cons here. But why not align incentives with expertise. Allow companies to test others' products, if they find serious problems then any fines resulting from a resulting FDA investigation are split between the govt and the company that found the issues. With generics there cannot be that much "This is a trade secret" since it is already in the open. I am sure they would be falling over each other to cripple the competition. Fire away.
- lsiebert 12y ago
  Then you are shifting regulation to cover testing for collusion. I think one of the issues is that fines need to be huge, penalties painful, and decisions punishing to companies who get caught doing wrong.
  - a3n 12y ago
    CEOs need to be held responsible in the same way that Navy Captains are held responsible: they're responsible for everything that happens under their command. If they don't govern to prevent this, then they need the probability of jail and ending their careers. "Accountability" is paraded around a lot these days when dressing up a commpany in buzzwords. Our employees are accountable. I'm accountable. You're accountable. Starting sending CEOs and CXXs to jail, and it will stop.

MichaelGG 12y ago

I dunno but doesn't the FAA do a fairly good job? I suppose failures in air flight result in obvious, immediate, disasters so it's a bit easier to keep everyone accountable. I am pretty surprised that this Indian company got away with so much and just kept going. What did the FDA have to lose? Was this big in the mainstream news?

karlkatzke 12y ago
The FAA does a pretty good job, but internally they treat their employees pretty poorly, which in turn results in quite a bit of slip. You just don't always see it because it's caught by employees who ARE invested in their careers and in flight safety in general.
lmm 12y ago
There was a story here not so long ago about how the FAA relies on voluntary reporting of near misses, and so fail to act before an outright disaster occurs.

wpietri 12y ago

I've always had respect for the FDIC. Its former director, Sheila Bair, wrote a good book about the 2008 financial crash, "Bull By The Horns", and in there she has a lot to say about what makes for good regulation. I think one the problems the US has had in the last couple decades is a lot more talk along the lines of "government isn't the solution, government is the problem". This can be a useful critique in particular instances. But when it's a general slogan of people in charge of government, it becomes a self-fulfilling prophecy.

kjs3 12y ago

The article is about an Indian drug company operating in India. Why the specious attempt to make this about the US?