kallend 2,182 #1 November 13, 2012 So companies like these can continue selling contaminated pharmaceuticals to Americans.... The only sure way to survive a canopy collision is not to have one. Quote Share this post Link to post Share on other sites
lawrocket 3 #2 November 13, 2012 Problem, John - they WERE regulated. Still are. Yet problems keep occurring. Think MORE regulations would help? My wife is hotter than your wife. Quote Share this post Link to post Share on other sites
kallend 2,182 #3 November 13, 2012 QuoteProblem, John - they WERE regulated. Still are. Yet problems keep occurring. Think MORE regulations would help? Unenforced "regulations" are not regulations. However, they have been finally caught, better late than never. The solution is better enforcement, not scrapping the regulations.... The only sure way to survive a canopy collision is not to have one. Quote Share this post Link to post Share on other sites
airdvr 210 #4 November 13, 2012 Quote“F.D.A. inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients,” Sarah Clark-Lynn, a spokeswoman for the agency, said in an e-mail. So far, Ms. Clark-Lynn said, no infections have been linked to Ameridose, but all its products have been recalled, and its operations have been suspended since early October at the request of state regulators, who say they need more time to investigate. So, there is already regulations in place but you think we need more regulations? Let me re-arrange the quote for you to see if you're OK with it this way. Quote“F.A.A. inspectors observed conditions and practices at (insert DZ here) which demonstrated that the firm could not consistently assure that their operations were safe for use by the public,” Sarah Clark-Lynn, a spokeswoman for the agency, said in an e-mail. So far, Ms. Clark-Lynn said, no deaths have been linked to (insert DZ here), but all its rigs have been recalled, and its operations have been suspended since early October at the request of state regulators, who say they need more time to investigate. This is where liberals and conservatives will never see eye to eye. I knew we had crossed the line when the big orange stickers started showing up on rigs.Please don't dent the planet. Destinations by Roxanne Quote Share this post Link to post Share on other sites
billvon 3,132 #5 November 13, 2012 We don't need less and we don't need more. We just need to enforce the ones we have. Quote Share this post Link to post Share on other sites
lawrocket 3 #6 November 13, 2012 QuoteThe solution is better enforcement, not scrapping the regulations. Okay. What is your proposal for better enforcement? A bidding war between taxpayers and private companies on the regulators to see who can pay the regulators more? My wife is hotter than your wife. Quote Share this post Link to post Share on other sites
beowulf 1 #7 November 13, 2012 Clearly someone needs to regulate the regulators!!! Quote Share this post Link to post Share on other sites
kallend 2,182 #8 November 13, 2012 Quote So, there is already regulations in place but you think we need more regulations? Your strawmen are pretty feeble. Where did I call for more?... The only sure way to survive a canopy collision is not to have one. Quote Share this post Link to post Share on other sites
CarpeDiem3 0 #9 November 13, 2012 News: "6,125 Proposed Regulations and Notifications Posted in Last 90 Days--Average 68 per Day" http://cnsnews.com/news/article/6125-proposed-regulations-and-notifications-posted-last-90-days-average-68-day Well, if more regulation is better, than Obama is doing a great job! So, all of these Obama regulations are worthless without a new legion of cops to enforce them? Maybe that's why the government is buying all those bullets. I sure hope so, because if you disobey Obama, you should suffer the consequences for it. Quote Share this post Link to post Share on other sites
lawrocket 3 #10 November 13, 2012 Quote Clearly someone needs to regulate the regulators!!! It's absolutely something that I call for. My wife is hotter than your wife. Quote Share this post Link to post Share on other sites
blueblur 0 #11 November 13, 2012 QuoteQuote So, there is already regulations in place but you think we need more regulations? Your strawmen are pretty feeble. Where did I call for more? Is not posting a thread with a sarcastic title and in that thread linking an instance where regulation failed an indirect call for more regulation and not less as the title says? Not an attack just a question.In every man's life he will be allotted one good woman and one good dog. That's all you get, so appreciate them while the time you have with them lasts. - RiggerLee Quote Share this post Link to post Share on other sites
kallend 2,182 #12 November 13, 2012 QuoteQuoteQuote So, there is already regulations in place but you think we need more regulations? Your strawmen are pretty feeble. Where did I call for more? Is not posting a thread with a sarcastic title and in that thread linking an instance where regulation failed an indirect call for more regulation and not less as the title says? . Nope. It's simply an argument against those who are forever calling for less regulation.... The only sure way to survive a canopy collision is not to have one. Quote Share this post Link to post Share on other sites
lawrocket 3 #13 November 13, 2012 QuoteIt's simply an argument against those who are forever calling for less regulation. What's the issue? The New England Compounding Center was subject to costly regulations and we know what happened. Sure, regulations didn't stop people from getting killed but it sure gave people jobs. My wife is hotter than your wife. Quote Share this post Link to post Share on other sites
kallend 2,182 #14 November 13, 2012 QuoteQuoteIt's simply an argument against those who are forever calling for less regulation. What's the issue? The New England Compounding Center was subject to costly regulations and we know what happened. Sure, regulations didn't stop people from getting killed but it sure gave people jobs. FDA wanted to take action in 2003 but deferred to the Massachusetts Board of Pharmacy, which decided to do nothing. The Mass. Board reports to the governor of Massachusetts. Guess who that was in 2003. Some "seriously conservative governor".... The only sure way to survive a canopy collision is not to have one. Quote Share this post Link to post Share on other sites
SkyDekker 1,465 #15 November 13, 2012 QuoteWhat's the issue? The New England Compounding Center was subject to costly regulations and we know what happened. Your argument is that because regulations get broken, there should not be regulations? Quote Share this post Link to post Share on other sites
kelpdiver 2 #16 November 13, 2012 QuoteQuoteProblem, John - they WERE regulated. Still are. Yet problems keep occurring. Think MORE regulations would help? Unenforced "regulations" are not regulations. However, they have been finally caught, better late than never. The solution is better enforcement, not scrapping the regulations. It's very difficult setting up a new drug line, with substantial FDA oversight. One of my close college friends spends all of her time traveling to manufacturing sites to ensure compliance and approval. This incident suggests that once its up and running, the FDA is going hands off. Quote Share this post Link to post Share on other sites
Andy9o8 3 #17 November 13, 2012 QuoteQuoteQuoteProblem, John - they WERE regulated. Still are. Yet problems keep occurring. Think MORE regulations would help? Unenforced "regulations" are not regulations. However, they have been finally caught, better late than never. The solution is better enforcement, not scrapping the regulations. It's very difficult setting up a new drug line, with substantial FDA oversight. One of my close college friends spends all of her time traveling to manufacturing sites to ensure compliance and approval. This incident suggests that once its up and running, the FDA is going hands off. Not to pick nits, but the FDA really doesn't go hands off; it does do periodic site inspections, some pre-announced, some by surprise. The problem is one of scale: there are only so many FDA inspectors to pay attention to X number of phrma mfg facilities. And FDA site inspections are time-consuming things: they don't last a matter of mere hours; the average site inspection by a team of, say, 2 or 3 inspectors can take upwards of 5 to ten 8-hour business days. (And that's just the on-site time; there's also the pre-inspection prep time, and the post-inspection analysis-and-report time, which are considerable.) In short: they're just overwhelmed. Quote Share this post Link to post Share on other sites
kelpdiver 2 #18 November 14, 2012 QuoteQuote It's very difficult setting up a new drug line, with substantial FDA oversight. One of my close college friends spends all of her time traveling to manufacturing sites to ensure compliance and approval. This incident suggests that once its up and running, the FDA is going hands off. Not to pick nits, but the FDA really doesn't go hands off; it does do periodic site inspections, some pre-announced, some by surprise. The problem is one of scale: there are only so many FDA inspectors to pay attention to X number of phrma mfg facilities. And FDA site inspections are time-consuming things: they don't last a matter of mere hours; the average site inspection by a team of, say, 2 or 3 inspectors can take upwards of 5 to ten 8-hour business days. (And that's just the on-site time; there's also the pre-inspection prep time, and the post-inspection analysis-and-report time, which are considerable.) In short: they're just overwhelmed. Whether it's by intent or result, having birds flying around is too hands off by my standards. Unenforced regulations and rules are pointless. It's pretty shocking to have this many people die or become seriously ill from a drug product due solely to neglectful action. Quote Share this post Link to post Share on other sites
Andy9o8 3 #19 November 14, 2012 QuoteQuoteQuote It's very difficult setting up a new drug line, with substantial FDA oversight. One of my close college friends spends all of her time traveling to manufacturing sites to ensure compliance and approval. This incident suggests that once its up and running, the FDA is going hands off. Not to pick nits, but the FDA really doesn't go hands off; it does do periodic site inspections, some pre-announced, some by surprise. The problem is one of scale: there are only so many FDA inspectors to pay attention to X number of phrma mfg facilities. And FDA site inspections are time-consuming things: they don't last a matter of mere hours; the average site inspection by a team of, say, 2 or 3 inspectors can take upwards of 5 to ten 8-hour business days. (And that's just the on-site time; there's also the pre-inspection prep time, and the post-inspection analysis-and-report time, which are considerable.) In short: they're just overwhelmed. Whether it's by intent or result, having birds flying around is too hands off by my standards. Unenforced regulations and rules are pointless. It's pretty shocking to have this many people die or become seriously ill from a drug product due solely to neglectful action. Then the key is to ramp-up compliance monitoring, inspections and enforcement. That takes personnel. That takes money. And we all know where that money comes from. Not very politically popular, is it? Quote Share this post Link to post Share on other sites
Kennedy 0 #20 November 14, 2012 So then you support dictatorship by fiat and control by unaccountable bureaucrats? Maybe we should put all model rockets under BATFE control an subject all RC and scale aircraft to all the FAA rules, right? Afterall, according to you there is only "I demand more" and "I demand less" positions on regulations. Or maybe you can take out the false dichotomy and excessive sarcasm-created strawman and we could try a constructive discussion. Which would you prefer, professor?witty subliminal message Guard your honor, let your reputation fall where it will, and outlast the bastards. 1* Quote Share this post Link to post Share on other sites
kallend 2,182 #21 November 14, 2012 Quote Maybe we should... Maybe you should get your ODS under control. Equating drug safety with government control of model airplanes is just plain absurd.... The only sure way to survive a canopy collision is not to have one. Quote Share this post Link to post Share on other sites
skiskyrock 0 #22 November 15, 2012 Quote Then the key is to ramp-up compliance monitoring, inspections and enforcement. That takes personnel. That takes money. And we all know where that money comes from. Not very politically popular, is it? It probably doesn't come from where you think. About 25% of the total FDA budget is user fees, and 77% of the new drug review process is paid for by the new drug application fee. Quote Share this post Link to post Share on other sites