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Drug Makers Reportedly Cut Deal with FDA on Fees
Another laughable shell game putting more money into the pockets of
bureacrats accountable to no one. This is like giving a guy with a severed arm a bigger box of band aids. FDA doesn't need more money, it needs to be purged of former drug execs and to have the threshold for drug efficacy and safety raised at least one order of magnitude. Until that happens, properly prescribed and dispensed medication will continue to be the third or fourth leading cause of death in the USA. Advise your congressman and other legislators that you won't continue to support politicians who permit a corrupt FDA to cut deals with anyone. FDA must be dismantled, restructured to more effectively accomodate CAM practices, managed by multidisciplinary medical experts with no ties to the drug makers (including stock ownership), and required to submit annually to an external audit to certify both financial and administrative integrity. As taxpayers, we have a right to accept nothing less! --- ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ --- Drug makers reportedly cut deal with FDA on fees By Bloomberg News | November 22, 2006 WASHINGTON -- Drug makers agreed to a 29 percent increase in payments to U S regulators to ensure speedy approvals of new medicines and step up safety monitoring, according to a person familiar with the accord. Representatives of drug makers and their trade associations also agreed for the first time to pay fees to have their consumer television commercials reviewed in advance by the U S Food and Drug Administration, the person said. The terms are spelled out in agreements between the industry and the FDA that are subject to approval by the Bush administration and Congress. The FDA wants to use some of the extra money to step up safety monitoring of drugs after they go into use. Democrats and Republicans in Congress criticized the agency's performance after antidepressants were linked to increased risk of suicide and painkillers such as Merck & Co.'s withdrawn Vioxx were tied to heart attacks and strokes. The new fees would be part of the renewal of a 14-year-old law that expires next year. The drug maker payments make it impossible for the FDA to be a "vigilant regulatory agency," said Sidney Wolfe, director of the health research group of the consumer group Public Citizen, an FDA critic . "The whole thing needs to be repealed." Public interest groups including Public Citizen say the FDA's $1.88 billion budget is inadequate for the agency to provide sufficient oversight of drugs. The FDA also regulates medical devices, food, and cosmetics. Payments to the FDA for new-medicine applications would increase by at least $87.3 million to $392.8 million in the fiscal year starting next October, the person said. About $30 million of the increase would be spent to upgrade the agency's monitoring of drug safety, according to this source. The FDA hopes to use some of the funds to improve detection and evaluation of harmful side effects after drugs are on the market, the person familiar with the agreement said. © Copyright 2006 Globe Newspaper Company. |
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Drug Makers Reportedly Cut Deal with FDA on Fees
PeterB wrote: Another laughable shell game putting more money into the pockets of bureacrats accountable to no one. This is like giving a guy with a severed arm a bigger box of band aids. FDA doesn't need more money, it needs to be purged of former drug execs and to have the threshold for drug efficacy and safety raised at least one order of magnitude. Until that happens, properly prescribed and dispensed medication will continue to be the third or fourth leading cause of death in the USA. Advise your congressman and other legislators that you won't continue to support politicians who permit a corrupt FDA to cut deals with anyone. FDA must be dismantled, restructured to more effectively accomodate CAM practices, managed by multidisciplinary medical experts with no ties to the drug makers (including stock ownership), and required to submit annually to an external audit to certify both financial and administrative integrity. As taxpayers, we have a right to accept nothing less! --- ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ --- Drug makers reportedly cut deal with FDA on fees By Bloomberg News | November 22, 2006 WASHINGTON -- Drug makers agreed to a 29 percent increase in payments to U S regulators to ensure speedy approvals of new medicines and step up safety monitoring, according to a person familiar with the accord. Representatives of drug makers and their trade associations also agreed for the first time to pay fees to have their consumer television commercials reviewed in advance by the U S Food and Drug Administration, the person said. The terms are spelled out in agreements between the industry and the FDA that are subject to approval by the Bush administration and Congress. The FDA wants to use some of the extra money to step up safety monitoring of drugs after they go into use. Democrats and Republicans in Congress criticized the agency's performance after antidepressants were linked to increased risk of suicide and painkillers such as Merck & Co.'s withdrawn Vioxx were tied to heart attacks and strokes. The new fees would be part of the renewal of a 14-year-old law that expires next year. The drug maker payments make it impossible for the FDA to be a "vigilant regulatory agency," said Sidney Wolfe, director of the health research group of the consumer group Public Citizen, an FDA critic . "The whole thing needs to be repealed." Public interest groups including Public Citizen say the FDA's $1.88 billion budget is inadequate for the agency to provide sufficient oversight of drugs. The FDA also regulates medical devices, food, and cosmetics. Payments to the FDA for new-medicine applications would increase by at least $87.3 million to $392.8 million in the fiscal year starting next October, the person said. About $30 million of the increase would be spent to upgrade the agency's monitoring of drug safety, according to this source. The FDA hopes to use some of the funds to improve detection and evaluation of harmful side effects after drugs are on the market, the person familiar with the agreement said. © Copyright 2006 Globe Newspaper Company. Sounds like they went from just allowing corruption to flourish amongst individuals working for the FDA to actually allowing the bureaucracy to systematically extort massive sums from pharma to help "speed up" approvals. Sounds like a third world country requiring bribery at all levels to get red tape "taken care of". Do they not have any people in staff that understand the basics of ethics? TC |
#3
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Drug Makers Reportedly Cut Deal with FDA on Fees
TC wrote: PeterB wrote: Another laughable shell game putting more money into the pockets of bureacrats accountable to no one. This is like giving a guy with a severed arm a bigger box of band aids. FDA doesn't need more money, it needs to be purged of former drug execs and to have the threshold for drug efficacy and safety raised at least one order of magnitude. Until that happens, properly prescribed and dispensed medication will continue to be the third or fourth leading cause of death in the USA. Advise your congressman and other legislators that you won't continue to support politicians who permit a corrupt FDA to cut deals with anyone. FDA must be dismantled, restructured to more effectively accomodate CAM practices, managed by multidisciplinary medical experts with no ties to the drug makers (including stock ownership), and required to submit annually to an external audit to certify both financial and administrative integrity. As taxpayers, we have a right to accept nothing less! --- ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ --- Drug makers reportedly cut deal with FDA on fees By Bloomberg News | November 22, 2006 WASHINGTON -- Drug makers agreed to a 29 percent increase in payments to U S regulators to ensure speedy approvals of new medicines and step up safety monitoring, according to a person familiar with the accord. Representatives of drug makers and their trade associations also agreed for the first time to pay fees to have their consumer television commercials reviewed in advance by the U S Food and Drug Administration, the person said. The terms are spelled out in agreements between the industry and the FDA that are subject to approval by the Bush administration and Congress. The FDA wants to use some of the extra money to step up safety monitoring of drugs after they go into use. Democrats and Republicans in Congress criticized the agency's performance after antidepressants were linked to increased risk of suicide and painkillers such as Merck & Co.'s withdrawn Vioxx were tied to heart attacks and strokes. The new fees would be part of the renewal of a 14-year-old law that expires next year. The drug maker payments make it impossible for the FDA to be a "vigilant regulatory agency," said Sidney Wolfe, director of the health research group of the consumer group Public Citizen, an FDA critic . "The whole thing needs to be repealed." Public interest groups including Public Citizen say the FDA's $1.88 billion budget is inadequate for the agency to provide sufficient oversight of drugs. The FDA also regulates medical devices, food, and cosmetics. Payments to the FDA for new-medicine applications would increase by at least $87.3 million to $392.8 million in the fiscal year starting next October, the person said. About $30 million of the increase would be spent to upgrade the agency's monitoring of drug safety, according to this source. The FDA hopes to use some of the funds to improve detection and evaluation of harmful side effects after drugs are on the market, the person familiar with the agreement said. © Copyright 2006 Globe Newspaper Company. Sounds like they went from just allowing corruption to flourish amongst individuals working for the FDA to actually allowing the bureaucracy to systematically extort massive sums from pharma to help "speed up" approvals. Sounds like a third world country requiring bribery at all levels to get red tape "taken care of". "Fast tracking" was enacted 13 years ago, so this latest ruse is just a slimely response to public outcry. How they plan to prevent another Vioxx is not even the question, since thousands of deaths are not enough for them. Merck is still profiting from these deaths with FDA approval. Do they not have any people in staff that understand the basics of ethics? David Graham did, and there are others. More scandal is coming. PeterB |
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Drug Makers Reportedly Cut Deal with FDA on Fees
To charge medical drug companies fees for drug approval and oversight is
a form of tax, better them then citizens. The current administration wanted to weaken the laws without changing them by reducing oversight funding. In a similar way the currant supplement drug industry already weak law is even less enforced for similar reasons. It too should be charged fees to fund oversight of it. I would propose broadening the supplement drug oversight by requiring that labels and actual amounts of contents and levels of the drugs be confirmed, just like aspirin is required. I would suggest too a rating system to reflect how well the drug has scientific backing for its claims. Vitamin c would get the highest rating for example while the many fly by night snake oil nostrums would get the lowest. An informed consumer is a better consumer and better positioned to take control of his health decisions. Marketing alone now rules the supplement drug industry which leaves the consumer the least informed. |
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