If you read the article that Kevin Freking wrote for the AP, based on a report produced by Henry Waxman entitled.
And you would have missed this penultimate statement from the flurry of memos (I read them all)
"I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process."
That was John Jenkins. And not one of the memos take issue with the position that FDA should preempt state requirements, especially those dredged up from tort proceedings.
The issue was and is about whether the FDA had enough control over labeling and safety monitoring in a coordinated fashion to produce the appropriate balance between risk and benefit, patient rights and company behavior. The goal is to encourage companies to do more to make sure labeling reflects the most up to date science and is communicated clearly and quickly to patients and everyone else to improve the use of the product and public health. The idea that FDA officials and their words are being twisted to promote a trial attorney agenda is disgusting beyond imagination...
Jenkins seeks a compromise which is now part of the fabric of the Critical Path and FDA authority under FDAAA:
"If we are going to go this route to protect sponsors, the appropriate balance in the favor of public health may be to give FDA more authority over labeling."
Which is exactly what has happened since 2003 when the memos were written. Where oh where have the self-serving solons at JAMA and NEJM been the past five years. They keep flogging VIoxx as an example of why tort lawyers should have control over labeoling. But within the FDA Vioxx was and is regarded as a safe drug under certain conditions that no longer apply since the drug was withdrawn:
Jenkins again:
"Had Merck not decided to voluntarily withdraw the product it would have been necessary for them to make labeling changes to add warnings about ,the new findings. We probably would not have issued an approval letter on the labeling changes since we would not have had access to the full study report for review so we could evaluate the actual data that would be added to the labeling. So, we probably would have agreed to interim labeling and asked Merck to submit it as a CBE and we would have made more official determinations later after we reviewed the full study report. "
It was the withdrawal of Vioxx and the failure to work with the FDA to make labeling changes that triggered the "Vioxx scandal" and the ensuing mess. Waxman wants us to believe FDA officials want more of the same instead of a science-based approach to label changes.. The Waxman report is all about manipulating the truth and is an example of how "facts" are treated in the courts that he and others would want to determine what is said about medicine and how it's practiced.
And you would have missed this penultimate statement from the flurry of memos (I read them all)
"I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process."
That was John Jenkins. And not one of the memos take issue with the position that FDA should preempt state requirements, especially those dredged up from tort proceedings.
The issue was and is about whether the FDA had enough control over labeling and safety monitoring in a coordinated fashion to produce the appropriate balance between risk and benefit, patient rights and company behavior. The goal is to encourage companies to do more to make sure labeling reflects the most up to date science and is communicated clearly and quickly to patients and everyone else to improve the use of the product and public health. The idea that FDA officials and their words are being twisted to promote a trial attorney agenda is disgusting beyond imagination...
Jenkins seeks a compromise which is now part of the fabric of the Critical Path and FDA authority under FDAAA:
"If we are going to go this route to protect sponsors, the appropriate balance in the favor of public health may be to give FDA more authority over labeling."
Which is exactly what has happened since 2003 when the memos were written. Where oh where have the self-serving solons at JAMA and NEJM been the past five years. They keep flogging VIoxx as an example of why tort lawyers should have control over labeoling. But within the FDA Vioxx was and is regarded as a safe drug under certain conditions that no longer apply since the drug was withdrawn:
Jenkins again:
"Had Merck not decided to voluntarily withdraw the product it would have been necessary for them to make labeling changes to add warnings about ,the new findings. We probably would not have issued an approval letter on the labeling changes since we would not have had access to the full study report for review so we could evaluate the actual data that would be added to the labeling. So, we probably would have agreed to interim labeling and asked Merck to submit it as a CBE and we would have made more official determinations later after we reviewed the full study report. "
It was the withdrawal of Vioxx and the failure to work with the FDA to make labeling changes that triggered the "Vioxx scandal" and the ensuing mess. Waxman wants us to believe FDA officials want more of the same instead of a science-based approach to label changes.. The Waxman report is all about manipulating the truth and is an example of how "facts" are treated in the courts that he and others would want to determine what is said about medicine and how it's practiced.
