5 ms·

I don't think think this has to do with "culture of bending rules". This just seems an excuse to me of what is evident every where in the world - greedy corpor

I don't think think this has to do with "culture of bending rules". This just seems an excuse to me of what is evident every where in the world - greedy corporates will always test the boundaries of the law to the maximum, to maximise their profits, testing the limits of the government to see what they can get away with. As the article itself highlights, once the FDA started being more strict complaints from India decreased and compliance increased. (And India was more responsive than China.) In fact, if the article is right, there seems to be an opportunity here for outsourcing FDA's inspection to a third party, as FDA seems to be finding it difficult to get its staff to stay in India (and possibly other asian countries) for inspection.

renholder 8y ago
>...as FDA seems to be finding it difficult to get its staff to stay in India (and possibly other asian countries) for inspection. The staff works for the FDA, which is a part of the government, yeah? In other words, it's not a for-profit business that can register itself it in India and, thereby, sponsor visas to live in India. I imagine that this is the principal reason why they can't "get its staff to stay in India".
- lotsofpulp 8y ago
  I doubt it, especially with the weight a US government agency would have in getting visas. On the other hand, professionals who have options, such as those working for the FDA, would probably need a sizeable premium to give up the comforts of living in a nicer place and instead have to live in a poorer, more crowded, dirtier, foreign country with increased risks.
  - walshemj 8y ago
    Exactly I looked at going expat for a large company and you basically got everything provided and you usually arranged your tax affairs to do very well out of it.
  - MrMorden 8y ago
    A US government employee stationed in a foreign country receives allowances that pay for the full cost of housing and utilities. In Mumbai, the housing allowance is relatively small as such things go ($1500ish/mo depending on grade level and family size), but there's also a 25% hardship allowance and an education allowance sufficient to send your K-12 children to an eye-wateringly-expensive private school. Other benefits include four to six weeks a year of vacation, three weeks a year of home leave, most likely both US and Indian holidays, and they probably have authority to throw in a 25% relocation incentive on top of that. FDA is also allowed to pay in excess of the usual federal pay cap for some positions. If they really can't find people willing to take that deal, they've got some major organizational issues that need to be addressed. (Source: I work in a different part of the federal government, but most of these rules are set by State.)
    - lotsofpulp 8y ago
      Organizational issues could also be a part, but there exists some number that would attract people. Personally, I wouldn’t give up my lifestyle in the US for a few hundred thousand a year, but make it $500k+ for 4 day workweeks and I might think about. There might be people qualified for the position that will do it for less, but the employer just needs to keep raising the number until people bite.
- webmobdev 8y ago
  They actually considered setting up offices in India and China, which would have meant that they don't even need to travel if they were posted there. But FDA officials just weren't keen to move there. Quoting from the article: "To help Indian factories change their culture in the wake of the Ranbaxy scandal, FDA leadership originally planned to put more inspectors on the ground. This proved harder than expected. Instead, the number of India staff shrank from a high of 12, in 2013. to only four at one point in 2017. Eight FDA employees are stationed at the India outpost now, including two drug inspectors, the agency said." "The original argument for having foreign offices was that staff would have a chance to learn the customs of the country and build key relationships with government officials to instill best practices, said the FDA’s Woodcock. Inspectors based in-country also don’t need a visa for each round of inspections, while those based in the U.S. do ..." "The problem is that the FDA can’t find people who want to live in India, Woodcock said. Difficulty hiring forced the agency to close its Mumbai office in 2016." "Because of those challenges, the agency has largely ditched plans to build up offices in India and China and is instead relying on a U.S.-based cadre of inspectors who fly overseas for a few weeks at a time, she said. This cadre was supposed to number as high as 20 people, but 12 were serving in its ranks as of December."
extrapickles 8y ago
Just as long as they have enough staff to rotate through, it will make the inspectors less likely to be corrupted as its much harder to successfully bribe new people frequently.
dgzl 8y ago
> greedy corporates will always test the boundaries of the law to the maximum, to maximise their profits, testing the limits of the government to see what they can get away with. I don't deny that penny-pincher execs are looking for loopholes, but how much of that is triggered from ignorance and not greed?
- GVIrish 8y ago
  It's always greed. I can guarantee you that if the FDA was defanged in the United States you'd see a massive spike in food and drug safety failures and counterfeiting. If a company can profit significantly from cutting corners inevitably someone will try it. The market may punish some of that behavior to the point that a new equilibrium would be reached but it would certainly be a more dangerous baseline. For many things the only thing that keeps greed and misconduct in check is a robust regulatory regime. They vast majority of people in any society neither has the time not expertise to check products for safety and authenticity.

renholder 8y ago

>...as FDA seems to be finding it difficult to get its staff to stay in India (and possibly other asian countries) for inspection. The staff works for the FDA, which is a part of the government, yeah? In other words, it's not a for-profit business that can register itself it in India and, thereby, sponsor visas to live in India. I imagine that this is the principal reason why they can't "get its staff to stay in India".

lotsofpulp 8y ago
I doubt it, especially with the weight a US government agency would have in getting visas. On the other hand, professionals who have options, such as those working for the FDA, would probably need a sizeable premium to give up the comforts of living in a nicer place and instead have to live in a poorer, more crowded, dirtier, foreign country with increased risks.
- walshemj 8y ago
  Exactly I looked at going expat for a large company and you basically got everything provided and you usually arranged your tax affairs to do very well out of it.
- MrMorden 8y ago
  A US government employee stationed in a foreign country receives allowances that pay for the full cost of housing and utilities. In Mumbai, the housing allowance is relatively small as such things go ($1500ish/mo depending on grade level and family size), but there's also a 25% hardship allowance and an education allowance sufficient to send your K-12 children to an eye-wateringly-expensive private school. Other benefits include four to six weeks a year of vacation, three weeks a year of home leave, most likely both US and Indian holidays, and they probably have authority to throw in a 25% relocation incentive on top of that. FDA is also allowed to pay in excess of the usual federal pay cap for some positions. If they really can't find people willing to take that deal, they've got some major organizational issues that need to be addressed. (Source: I work in a different part of the federal government, but most of these rules are set by State.)
  - lotsofpulp 8y ago
    Organizational issues could also be a part, but there exists some number that would attract people. Personally, I wouldn’t give up my lifestyle in the US for a few hundred thousand a year, but make it $500k+ for 4 day workweeks and I might think about. There might be people qualified for the position that will do it for less, but the employer just needs to keep raising the number until people bite.
webmobdev 8y ago
They actually considered setting up offices in India and China, which would have meant that they don't even need to travel if they were posted there. But FDA officials just weren't keen to move there. Quoting from the article: "To help Indian factories change their culture in the wake of the Ranbaxy scandal, FDA leadership originally planned to put more inspectors on the ground. This proved harder than expected. Instead, the number of India staff shrank from a high of 12, in 2013. to only four at one point in 2017. Eight FDA employees are stationed at the India outpost now, including two drug inspectors, the agency said." "The original argument for having foreign offices was that staff would have a chance to learn the customs of the country and build key relationships with government officials to instill best practices, said the FDA’s Woodcock. Inspectors based in-country also don’t need a visa for each round of inspections, while those based in the U.S. do ..." "The problem is that the FDA can’t find people who want to live in India, Woodcock said. Difficulty hiring forced the agency to close its Mumbai office in 2016." "Because of those challenges, the agency has largely ditched plans to build up offices in India and China and is instead relying on a U.S.-based cadre of inspectors who fly overseas for a few weeks at a time, she said. This cadre was supposed to number as high as 20 people, but 12 were serving in its ranks as of December."

extrapickles 8y ago

Just as long as they have enough staff to rotate through, it will make the inspectors less likely to be corrupted as its much harder to successfully bribe new people frequently.

dgzl 8y ago

> greedy corporates will always test the boundaries of the law to the maximum, to maximise their profits, testing the limits of the government to see what they can get away with. I don't deny that penny-pincher execs are looking for loopholes, but how much of that is triggered from ignorance and not greed?

GVIrish 8y ago
It's always greed. I can guarantee you that if the FDA was defanged in the United States you'd see a massive spike in food and drug safety failures and counterfeiting. If a company can profit significantly from cutting corners inevitably someone will try it. The market may punish some of that behavior to the point that a new equilibrium would be reached but it would certainly be a more dangerous baseline. For many things the only thing that keeps greed and misconduct in check is a robust regulatory regime. They vast majority of people in any society neither has the time not expertise to check products for safety and authenticity.