icnmgrjill
09-27-2006, 01:08 PM
FDA Losing Credibility with Public and Own Staff
This is a VERY interesting article that was released today in the OBGYN news... and I think its worth a read. Many of you know that I've had a devil of a time trying to get the FDA to release the long term data for the Interstim device... with no luck after years of trying. My Senator is now working on it. So, the fact that FDA's own staff now suggest that there is an effort to support big business in lieu of neutral evaluations of new drugs, etc... is a concern. So, if that's the case, who can we rely on to protect the patients??? - Jill
Here's the first few paragraphs!
WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent, unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.
In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.
Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.
In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”
Read the full article at:
http://www.obgynnews.com/article/PIIS0029743706721632/fulltext#
This is a VERY interesting article that was released today in the OBGYN news... and I think its worth a read. Many of you know that I've had a devil of a time trying to get the FDA to release the long term data for the Interstim device... with no luck after years of trying. My Senator is now working on it. So, the fact that FDA's own staff now suggest that there is an effort to support big business in lieu of neutral evaluations of new drugs, etc... is a concern. So, if that's the case, who can we rely on to protect the patients??? - Jill
Here's the first few paragraphs!
WASHINGTON — Members of the scientific community have raised a red flag over the apparent increasing influence of money and politics on what are supposed to be the independent, unbiased internal workings of the Food and Drug Administration and other federal watchdog agencies.
In a recent confidential survey of staff scientists in the FDA's Center for Drug Evaluation and Research, 19% reported being pressured to push through a drug about which they had reservations and 66% said that they were less than wholly confident that the FDA adequately monitors the safety of drugs after they reach the market.
Across the agency, 50% of respondents said they did not believe that the FDA was headed in the right direction, according to the survey by the Union of Concerned Scientists and Public Employees for Environmental Responsibility.
In the words of one staff scientist: “The FDA is presently being stacked at every management level, including the lowest levels, based on those who will support the big companies' agenda, and the implications for safety and efficacy will be felt long into the future.”
Read the full article at:
http://www.obgynnews.com/article/PIIS0029743706721632/fulltext#