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This 23-page "privileged and confidential" Philip
Morris (PM) discussion piece outlines the thinking
behind Philip Morris' 180-degree turn from stringently
opposing U.S. Food and Drug Administration (FDA) of cigarettes to in
fact seeking such regulation, the company's logic
in proceeding down this path and what the
company hopes for and fears in FDA regulation. It was
written in by Mark Berlind (Assistant General Counsel of Philip
Morris Worldwide Regulatory Affairs) in 1998.
Berlind first recaps the history of PM's
opposition to FDA regulation and recommends instead that PM USA
advocate for regulation as a way to maintain the status quo, or
"perpetuate the existing framework's philosophy that adults
continue to be permitted to assume" the inherent risks of
cigarette smoking:
"...enactment of a new regulatory regime that would (a)
permit the federal government to assure itself that the industry's
design and manufacturing processes do not exacerbate the inherent risks
of cigarette smoking and (b) perpetuate the existing framework's
philosophy that adults should continue to be permitted to assume --
without governmental interference -- those risks so long as they have
been adequately informed of them. In addition, [this
paper] will recommend that the company continue to support
federal measures legitimately aimed at reducing youth access to
cigarettes, and oppose proposals that would infringe on its First
Amendment rights without its consent."
Berlind compares potential regulatory regimes for
cigarettes to consumer safety regimes that have
been applied to other risky products, such as high
fat foods, guns, alcohol and gambling. Among
these Berlind finds "no instance in which the government
has established a regime that would permit unelected agencies to either
ban the product or mandate significant design changes intended to
reduce consumer risk." Berlind concludes that rather
than banning products, the FDA's role instead has been "on
labeling and ensuring that consumers are not
misled." He points out that the gun industry is
"largely unregulated," and that the few restrictions
placed upon guns were created by legislative action and not
regulatory action. He states with respect to guns that
"current law largely leaves it to consumers to discern the
riskiness of the products by themselves..."
Berlind also observes that
gambling laws "are not directed nearly as much at trying
to discourage gambling as they are at ensuring that only state-sanctioned
(or sponsored) gambling occurs, and that the revenues are directed through
the proper channels. The view that gambling is addictive and
socially destructive does not, however, seem to have dampened official
enthusiasm for perpetuating the practice."
With regard to alcohol, Berlind states
that while many laws exist regulating misleading brand names,
posting of health warnings, prohibitions on false statements,
etc. "...there are no regulations whatsoever on product
design or manufacture of alcoholic beverages either at the state or
federal level. No agency is charged with the responsibility of
attempting to reduce alcohol consumption by adults...The prevailing
philosophy appears to be that...even though the product allegedly can
impair health and has been characterized as addictive, the consumer should
be left along to decide to consume alcohol or not, in accordance with his
or her individual preferences."
After these comparisons, Berlind says the
FDA's "safe and effective" requirement for regulated products would
be "troubling," saying that FDA is required to ban any drug or
medical device not found to be safe and effective. "Unless
the law is amended, FDA jurisdiction over tobacco products could
ultimately lead to a new Prohibition."
Berlind concludes that "sensible
regulation would continue to permit adults to assume the inherent
risks of smoking, while allocating to the government the twin tasks of
ensuring that manufacturers don't created additional risk though
their design and manufacturing processes, on the one hand, and continuing
to conduct appropriate research about the nature of the inherent risks and
keeping consumers informed of them, on the
other." These limited parameters for regulation
appear to be the broad goals PM seeks in FDA regulation: that such
regulation will generally preserve the status quo of "adult choice" about
smoking, assure cigarette manufacturers don't create any more risks
than their products currently pose, to place FDA in charge of
informing citizens about the risks of smoking, to prevent FDA from
getting any authority to reduce or eliminate any naturally-occurring
harmful constituents in cigarettes (to relegate this only to
Congress). | 
