Thursday, April 16, 2009

Law Review Article Concludes that FDA Tobacco Legislation Would Be a Public Health Disaster, Making the FDA Complicit in Harming the Public's Health

An article published in the current issue of Administrative Law Review, published by the American University Washington College of Law, analyzes the FDA tobacco legislation currently before the United States Senate and concludes that enactment of this bill would be a public health disaster, resulting in the FDA becoming complicit with the tobacco companies in harming the public's health (see: Barker KG. Thank you for regulating: why Philip Morris's embrace of FDA regulation helps the company but harms the agency. Administrative Law Review 2009; 61(1):197-224).

The article provides a thorough analysis of the history of legislation that would give the FDA authority to regulate cigarettes as well as of the details of the legislation currently before Congress. The major conclusions of the analysis are as follows:

1. While the bill, on the surface, appears to be a comprehensive piece of tobacco regulatory legislation, "Upon closer look, however, the legislation contains crucial industry-lobbied compromises that would give Philip Morris the benefits of regulation, while allowing the company to mitigate disadvantages."

2. While [the bill's] public-health benefits are unclear, what is more disturbing is that the bill's provisions might wreck an already-embattled FDA. [The bill] would logistically burden the agency and potentially render FDA an unwilling participant in Philip Morris's public-relations move."

3. The bill is "the latest example of big business capturing regulation." By this, Barker means an industry fending off stronger (and perceived inevitable) regulation by agreeing to weakened legislation that appeases public health advocates and lawmakers but mitigates any serious harms to the industry.

4. The bill represents "compromise-laden legislation [that] would structurally burden FDA and undermine its mission of protecting the public health."

5. The paper's ultimate conclusion is that: "forcing FDA to issue standards for approving what would still be deadly products creates an ideological crisis. Cigarette companies' survival depends on maintaining smoking rates. The public health depends on reducing smoking rates. Since reduced-risk-branded cigarettes would inform the public that the product had been made safer, it is likely that more people would smoke. If more people smoke because of an FDA rule, then the agency would be complicit with the tobacco companies in harming the public health."

The review explains how the bill follows the historical model of industries "capturing" regulation through its numerous loopholes, by which the FDA is rendered essentially powerless and the tobacco companies - especially Philip Morris - are given the power to effectively fight and resist any meaningful regulation. Barker explains that the compromises in the bill allow the industry to fight any regulation that would harm its profits and predicts that the industry will overwhelm the FDA with "drawn-out appeals processes" that will "discourage future industry-harming regulatory measures and could be almost as effective as winning on appeal."

Thus, Barker sees the bill's tobacco product standards as a pointless exercise in futility that will not result in any meaningful protection of the public's health.

In addition, Barker argues that the bill's "reduced exposure" provisions will create a false impression that cigarettes have been made safer, giving tobacco companies a tremendous marketing opportunity at the expense of the deception of their consumers. As Barker states: "reduced-exposure branding would only foster consumers' unscientific, unfounded inferences."

Furthermore, Barker points out that the FDA is already "riddled with problems" and that this legislation would overwhelm the agency and possibly lead to an institutional disaster from which it would "take decades to recover." Also, Barker argues that the legislation would undermine the agency's mission of protecting the public's health. Worst of all, it would actually make the FDA complicit in harming the public's health, as FDA regulation will create the perception that cigarettes are safer -- leading to increased smoking -- when they are actually not.

Thus, the bill will not only increase smoking rates but it will lead to essentially the defrauding of the American public. The only difference between the bill's regulatory scheme and the status quo is that the defrauding will be carried out by the federal government, rather than by the tobacco companies themselves.

Ultimately, Barker argues against the passage of the FDA legislation and suggests that FDA regulation of tobacco products is not a sensible idea in the first place. But he warns that if such an approach is considered, the approach taken by the Campaign for Tobacco-Free Kids with this bill is not an appropriate way to develop public health policy: "if FDA regulation is the means chosen to combat cigarette smoking and tobacco-related health problems, Congress must give broad regulatory authority to the agency. The bill cannot have compromises with the industry and certainly cannot contain a tobacco product standard that invites courtroom challenges, nor can it have a deadline that requires FDA to issue rules that might ultimately harm the public health. While reporters, industry competitors, and public-health advocates have tried to understand for years why Philip Morris supports FDA regulation, the answer is somewhat obvious: when legislation provides for tamed regulation, the agency is already captured."

The Rest of the Story

This analysis of the FDA tobacco legislation is an important one, because it comes from a neutral source: a law student who is not otherwise involved in the tobacco issue. His stinging indictment of the legislation and of the process by which the bill came to be should be a striking wake-up call to the health groups which are supporting this legislation.

Barker makes many of the same arguments I have advanced on this blog, but comes to his conclusions based on an objective and independent analysis of the legislation.

The health groups supporting this bill owe it to the public to respond to the criticisms leveled by Barker in this article. After all, the charges he makes are serious ones: if correct, this legislation will:

1) transfer the fraud that was committed by cigarette companies over into the hands of the federal government;

2) increase smoking rates; and

3) overwhelm and severely harm the already-troubled FDA;

4) undermine the underlying mission of the FDA; and

5) make the federal government complicit with the tobacco companies in harming the public's health.

At the very least, the American public (and the constituents of the anti-smoking and health groups supporting the legislation) deserve a response to these criticisms.

At the very best, the health and anti-smoking groups should reverse their positions on this bill, go back to the drawing board, and collaborate on a truly effective and meaningful piece of legislation that would actually reduce, rather than increase, the use of the nation's most hazardous consumer product.

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