The FDA Commissioner also testified that the legislation would harm the public's health itself by creating a perceived FDA stamp of approval for cigarettes, which would lead consumers to believe that cigarettes are safer than they previously thought. This would encourage people to smoke more, rather than less. The bill, then, would have what the Commissioner calls the "perverse" effect of increasing, rather than decreasing cigarette consumption.
The testimony was not immediately available after the hearing because it was submitted in written form. Dr. von Eschenbach declined the offer to testify in person because unlike the respect shown to other Administration officials who are customarily allowed to testify independently, the Committee apparently insisted that the FDA Commissioner testify among a panel of non-government officials.
According to his testimony:
"We have concerns that the bill could undermine the public health role of FDA. ... FDA is a public health agency, structured to facilitate and regulate the development of products that promote and protect the public health. The Agency enjoys widespread public support for its role in defining and assuring effectiveness and safety of products they consume. Our responsibility includes approving products based on scientific evidence that benefits of the product outweigh the risks. We have extensive experience in such evaluations and we have developed finely tuned methodologies."
"H.R. 1108 would ask us to apply this framework to tobacco products that, when used as intended, produce disease rather than promote health. FDA cannot “approve” a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks. It will be very challenging to transform existing science into a logical regulatory structure. There is little science available to the FDA on which to base decisions on tobacco product standards (such as reducing or eliminating harmful constituents, reducing the amount of nicotine in products, or requiring changes to tobacco product components) or premarket approval."
"Associating the Agency with the approval of these inherently dangerous products would undermine the Agency’s mission. Indeed, associating any agency whose mission is to promote public health with the approval of inherently dangerous products would undermine its mission and likely have perverse incentive effects. This proposed legislation would direct FDA to regulate tobacco products in a variety of ways, most significantly by the establishment of tobacco product standards, pre-market approval of new tobacco products, and standards for the sale of modified risk tobacco products. Approval of tobacco products that are dangerous to health even if used as directed runs directly counter to FDA’s historical mission to protect and promote the public health by reviewing and approving products that prevent and treat disease, not products whose only impact on health is to cause disease."
"In addition, the provisions authorizing pre-market approval of new and reduced risk tobacco products are of special concern. Most fundamentally, we are concerned that FDA “approval” of tobacco products may become confused with the Agency’s regulation of therapeutic products such as drugs and devices. For example, the bill provides potential loopholes for grandfathered” and “substantially equivalent” products, which will be permitted to stay on the market. We are concerned that the public will believe that products “approved” by the Agency are safe and that this will actually encourage individuals to smoke more rather than less."
"As another example, the bill would attempt to apply current requirements for medical products such as drugs and medical devices to tobacco products. These include adverse event reporting, adulteration and misbranding, and record keeping. These concepts are not applicable to inherently dangerous tobacco products. One example of the awkwardness of applying medical product standards to tobacco products is contained in the bill’s definition of an adulterated tobacco product. Section 902 of the bill provides that a “tobacco product shall be deemed to be adulterated if—‘(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health.’”
"Tobacco products, however, are intrinsically injurious to health, i.e. adulterated according to this definition. This concept, therefore, does not fit when applied to the regulation of tobacco products. There are other examples in the bill where similar problems would arise."The Rest of the Story
Based on the FDA Commissioner's testimony (which mirrors the major comments I have been making about this legislation for the past two years), the health and anti-smoking groups should immediately drop their support for this legislation and go back to the drawing board.
Imposing regulatory responsibility on an agency which clearly has no interest in accepting that responsibility is a recipe for disaster. The Agency clearly agrees with me: this legislation will undermine the public health role of the FDA. And more importantly perhaps, it will undermine the public's health itself by increasing cigarette consumption.
With a stroke of the pen, this proposed law could undermine decades of public health efforts to underscore to the public the serious health consequences of smoking and the absence of any health benefit to smoking any particular kind of cigarette (e.g., low-tar, low-nicotine, additive-free, natural, etc.).
According to the FDA Commissioner (again, in agreement with many of my previous postings), the legislation will increase, not decrease cigarette consumption. Rather than "save countless lives," as the Campaign for Tobacco-Free Kids and American Medical Association claim, it will actually result in increased deaths from cigarettes.
That's hardly the prescription for a sound public health measure.
I think it's time that the health groups follow exactly what the Doctor ordered: scrap this absurd plan, which will protect Philip Morris profits at the expense of the public's health, and go back to the drawing board.
We should be able to do a whole lot better than this.