The FDA will be holding a public workshop in March on "Third party governance". This refers to a section of the Institute of Medicine's report on regulation of Modified Risk tobacco Products (MRTPs) that urged the FDA to require objective third parties to oversee any testing and clinical trials that tobacco companies perform, or have performed, on products they want to submit for approval as MRTPs. Approval would allow them to make marketing claims that their product reduces risks of smoking-related diseases.
Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop
A major problem with complying with any of this is that most organizations that conduct clinical trials (e.g., universities, hospital centers, private research organizations, etc.) have instituted policies against accepting funds from tobacco companies. Even if the tobacco companies could organize and conduct the testing themselves, their institution's prohibition against accepting tobacco company money would effectively prevent reputable "third parties" from conducting the oversight.
The editor of the Tobacco Control, Ruth Malone, was invited to be a speaker at the workshop. This was her response.
BMJ Group blogs: TC News and Views Online » Blog Archive » A letter to the US FDA from Tobacco Control Editor, Ruth Malone
I would disagree with this assertion: "Public health advocates (and presumably the FDA) have a stake in saving lives." IMO, consumers have a stake in saving lives. So-called public health advocates such as Ms. Malone have a stake in insisting things be done "my way or the highway." Frankly, I'm not sure what the FDA's Center for Tobacco Products has a stake in. So far I am not convinced that it is in saving lives.
Malone further states, "Tobacco companies have a stake in protecting profits." This is true. However, has it occurred to Ms. Malone that tobacco companies must have a stake in saving lives? Saving lives works to keep their customer-base from dying off. Dead customers don't buy anything.
How confident does Ms. Malone's letter to the FDA make you feel that we will ever be seeing honest and accurate labeling of tobacco products? How confident does this make you feel that smokers will ever be offered a third choice, beyond "quit or die"?
Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop
A major problem with complying with any of this is that most organizations that conduct clinical trials (e.g., universities, hospital centers, private research organizations, etc.) have instituted policies against accepting funds from tobacco companies. Even if the tobacco companies could organize and conduct the testing themselves, their institution's prohibition against accepting tobacco company money would effectively prevent reputable "third parties" from conducting the oversight.
The editor of the Tobacco Control, Ruth Malone, was invited to be a speaker at the workshop. This was her response.
BMJ Group blogs: TC News and Views Online » Blog Archive » A letter to the US FDA from Tobacco Control Editor, Ruth Malone
I would disagree with this assertion: "Public health advocates (and presumably the FDA) have a stake in saving lives." IMO, consumers have a stake in saving lives. So-called public health advocates such as Ms. Malone have a stake in insisting things be done "my way or the highway." Frankly, I'm not sure what the FDA's Center for Tobacco Products has a stake in. So far I am not convinced that it is in saving lives.
Malone further states, "Tobacco companies have a stake in protecting profits." This is true. However, has it occurred to Ms. Malone that tobacco companies must have a stake in saving lives? Saving lives works to keep their customer-base from dying off. Dead customers don't buy anything.
How confident does Ms. Malone's letter to the FDA make you feel that we will ever be seeing honest and accurate labeling of tobacco products? How confident does this make you feel that smokers will ever be offered a third choice, beyond "quit or die"?
Last edited: