Monday, March 05, 2007

FDA Legislation Ensures No Meaningful Regulation Could Take Place; Major Decisions Reserved to Congress; Politics, Not Science Would Dictate Policy

Although I've argued that the regulatory scheme that would be established by the proposed FDA tobacco legislation is absurd and that it would do nothing to protect the public's health and a lot to harm public health, the legislation contains an additional protection to ensure that any meaningful regulation of tobacco products that might actually accomplish something useful could easily be blocked by the tobacco companies.

It's something I call the Philip Morris escape clause, and it essentially establishes procedures so that Congress, rather than the FDA, would make the final decisions regarding any major tobacco regulations. This would ensure that the major decisions are based on politics, rather than science and public health policy concerns. And this is precisely what Philip Morris wants, because it enables the tobacco companies to use their influence with Congress to block any meaningful FDA tobacco rules with a simple majority vote of both houses of Congress.

Moreover, the legislative process that must be followed for Congress to overrule any major FDA rule is a streamlined one: all that is required is a joint resolution of Congress. The rules have been changed so that it becomes much harder to block such a resolution. Many of the usual parliamentary procedures that can be used to block legislation cannot be employed to block these joint resolutions to overturn FDA tobacco regulations.

And here's the kicker: if Congress does overturn a particular rule, it is permanent. The FDA is forever prohibited from re-issuing that rule or anything similar until such time as Congress decides to allow the Agency to do so.

In other words, the legislation gives Congress undue control over the regulatory process, ensuring that the tobacco companies can rely upon their influence on politicians to block any regulation that would be harmful to their profits.

Perhaps the most important implication of this escape clause is that it would ensure that the FDA never is able to reduce nicotine levels in cigarettes to extremely low levels. Any attempt by FDA to reduce the nicotine levels so low that they threatened to reduce cigarette consumption would be met, without a doubt, by a unified lobbying effort by the tobacco companies to get Congress to disapprove those regulations. And again, a streamlined process with only a majority vote and without the usual parliamentary blocking procedures is prescribed by the legislation.

The bill makes it as easy as possible for the tobacco companies to block any meaningful regulation of their products. Politics, and tobacco industry profits, not science, is left as the ultimate arbiter of the public's health.

There is no way, for example, that Congress would allow the FDA to reduce nicotine levels so far that they substantially reduce cigarette consumption and threaten tobacco industry profits, as well as government (federal and state) revenues. Especially with the dependence of so many critical government programs on cigarette revenues (thanks to the Master Settlement Agreement), Congress would never allow any FDA regulation that would threaten cigarette consumption substantially.

The Rest of the Story

The FDA tobacco legislation, which is supported by Philip Morris and the Campaign for Tobacco-Free Kids and many other major anti-smoking groups, contains an escape clause that would allow Philip Morris or any other tobacco company to appeal to Congress to overturn any major regulation that the company does not like. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.

Such a Congressional decision is final, and permanently enjoins the FDA from re-issuing such a rule: even if political conditions change and Congress might be more favorable towards such a regulation at some future time.

Given the lobbying power of Big Tobacco in Congress, this essentially gives the companies the ability to block any substantial tobacco rules that would be expected to have significant financial consequences -- precisely those which might otherwise have public health benefit. The legislation makes it easier for Big Tobacco to obtain a Congressional override of an FDA rule by prescribing rules for the consideration of such override legislation that limit the ability of legislators who oppose such a measure to kill it (i.e., it prescribes rules that take away many of the procedural moves by which legislation can normally be killed).

By keeping all major regulatory decisions within the oversight of Congress, the legislation politicizes what should be primarily scientific and public health issues. This provision in the legislation essentially represents an "escape clause" by which the tobacco companies could escape unfavorable regulation simply by mobilizing enough support within Congress to pass a joint resolution of rule disapproval. And the rules governing the procedure by which such a joint resolution is considered are geared towards making it more difficult than normal to kill such a measure.

The bill achieves this escape for Big Tobacco by making any major FDA rules subject to section 801 of Title 5 of the United States Code (Congressional review of agency rulemaking).

The killer provision in the bill, almost certainly inserted at the insistence of Philip Morris (and for some inexplicable reason agreed to by the Campaign for Tobacco-Free Kids and other health groups), is section 915, entitled "Congressional Review Provisions." It is tucked away in fine print near the end of the bill, so that you really have to read every word of the bill to even know that it is there.

It states, simply: "In accordance with section 801 of title 5, United 8 States Code, Congress shall review, and may disapprove, any rule under this chapter that is subject to section 801."

And unfortunately, section 801 of title 5 of the United States Code states that: "A rule shall not take effect (or continue), if the Congress enacts a joint resolution of disapproval, described under section 802, of the rule."

Even more unfortunately: "A rule that does not take effect (or does not continue) under paragraph (1) may not be reissued in substantially the same form, and a new rule that is substantially the same as such a rule may not be issued, unless the reissued or new rule is specifically authorized by a law enacted after the date of the joint resolution disapproving the original rule."

In other words, the decision of Congress represents a permanent injunction against FDA issuing that rule.

To add insult to injury, section 802 of title 5 prescribes that: "In the Senate, if the committee to which is referred a joint resolution described in subsection (a) has not reported such joint resolution (or an identical joint resolution) at the end of 20 calendar days after the submission or publication date defined under subsection (b)(2), such committee may be discharged from further consideration of such joint resolution upon a petition supported in writing by 30 Members of the Senate, and such joint resolution shall be placed on the calendar."

What this means is that the resolution to disapprove an FDA tobacco rule cannot be killed in committee. It takes only 30 votes to force the resolution out of committee to the full Senate for a vote.

The icing on the cake is that: "it is at any time thereafter in order (even though a previous motion to the same effect has been disagreed to) for a motion to proceed to the consideration of the joint resolution, and all points of order against the joint resolution (and against consideration of the joint resolution) are waived. The motion is not subject to amendment, or to a motion to postpone, or to a motion to proceed to the consideration of other business. A motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order. If a motion to proceed to the consideration of the joint resolution is agreed to, the joint resolution shall remain the unfinished business of the Senate until disposed of."

This provision blocks many of the parliamentary procedures that normally can be used to block legislation. It makes it as easy as possible for the tobacco companies to get a joint resolution of disapproval of an FDA tobacco rule enacted by Congress.

What tobacco control and public health advocates and the public need to realize is that the bill could have exempted these regulations from Congressional review. In fact, the bill does exempt from Congressional review the advertising and youth access regulations that the Secretary of Health and Human Services would be forced to promulgate (the 1996 FDA regulations). However, the remainder of the rules that FDA is given the authority to promulgate are not exempted from the Title 5, Section 801 provisions.

Obviously, Philip Morris does not feel threatened by the youth access regulations (which will do nothing) and advertising restrictions (which will do little and may also be overturned by the Supreme Court). However, a more serious threat, such as one which could threaten its profits, is subject to the Congressional review provisions.

Presumably, the simple inclusion in the legislation of a clause stating that ‘‘Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act" would allow FDA to regulate tobacco products without explicit Congressional review and would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.

That the Campaign for Tobacco-Free Kids has stated that this legislation is "strong" and puts "protection of the public health first" is unfortunate, given their presumable knowledge that this "Philip Morris escape clause" was tucked away into the bill, apparently with the Campaign's approval.

It is inexplicable to me how any anti-smoking or public health group could support the legislation, given the presence of this clause, which clearly provides special protection to the tobacco companies at the expense of the protection of the public's health.

Even more inexplicable is how these same anti-smoking groups could refuse to consider any amendment to the legislation which would eliminate this escape clause. The Campaign for Tobacco-Free Kids and its friends supporting this legislation have repeatedly refused to entertain any changes to the legislation, even amendments that would substantially strengthen the bill and give it some teeth.

In fact, the American Cancer Society - one group that has joined Philip Morris in promoting this legislation - was quoted in the Winston-Salem Journal as stating that it would oppose any changes to the legislation: "Wendy Selig, the vice president of legislative affairs for the American Cancer Society, said her organization 'strongly supports the bill as it is written now,' and would oppose any changes. 'This bill has been vetted broadly within the health community, (and) I think what this bill sets out to do is a huge step forward for public health,' she said."

I find it very unfortunate that a public health group would be unwilling to consider any improvements in a piece of public health legislation. The appearance of this is that the American Cancer Society has agreed to some back-room deal with Philip Morris and doesn't want to strengthen the bill because they are afraid that the deal will fall through.

That is not serving the public's health. That is protecting the financial interests of Philip Morris at the expense of the public's health.

And ultimately, that's what this whole issue comes down to. The escape clause is one of numerous provisions insisted upon by Philip Morris to protect its profits and ensure that regulation of tobacco products, while real, would be limited and that any meaningful regulation could easily be blocked on political and economic grounds. The public health groups who are supporting the legislation and refusing to even consider strengthening it have essentially sold out the public's health for the financial interests of Big Tobacco.

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