Monday, July 23, 2007

Senator Enzi to Introduce Alternative to FDA Tobacco Legislation; Bill Far Stronger than FDA Bill; Embarrassment for Major Anti-Smoking Groups

Senator Michael Enzi (R-WY) has announced that he intends to introduce legislation into Congress that would serve as an alternative to the FDA tobacco legislation that is being supported by many anti-smoking and health groups as well as by Philip Morris.

In contrast to the FDA bill, Senator Enzi proposes an approach that relies on programs and incentives to reduce cigarette consumption and smoking rates, rather than on an attempt to regulate cigarettes to make them safer.

Senator Enzi explains the premise behind his alternative approach to federal tobacco control policy as follows: "Some have suggested that FDA regulation of tobacco is the way toward safer tobacco products. But we know that there is no such thing as a safe cigarette. Proposals to have FDA regulate tobacco are a misguided attempt to force a deadly product into the regulatory structure developed for drugs and devices - products which DO have health benefits. This new scheme for tobacco would be very costly, and would not result in much of a health benefit."

"Furthermore, FDA review and approval of tobacco products sends a terrible public health message - creating the sense that cigarettes are safe or can be made safer, when we know they cannot."

"Importantly, the proposal under consideration by the HELP Committee explicitly states that the FDA will not be permitted to ban nicotine or tobacco. That is not true regulation. That bill would gut the authority that Congress has bestowed and staunchly defended for the FDA - the authority to remove health threats from the marketplace. The FDA cannot be put in the position of approving a product which years of science and the personal experience of far too many Americans has shown to be dangerous. Simply put, tobacco kills people. We can do better."

"We should focus our efforts instead on helping people quit using tobacco, or better yet, to never start. The Enzi HEALTH Act would have a dramatic impact on the number of smokers in this country. ... It would ... use proven approaches to help people quit and implement tried and true prevention programs."

The two most important aspects of the legislation are as follows:

1. An increase in the federal excise cigarette tax, with revenues allocated to support a national counter-advertising campaign and grants to states for tobacco prevention and cessation media campaigns (there are similar provisions for other tobacco products). The amount of the increase varies by tobacco product, but is about 10 cents per pack on cigarettes. Revenues are allocated as follows: 25% to national and state tobacco prevention and cessation programs, including counter-advertising campaigns; 50% to Medicare; 25% to Medicaid.

2. The establishment of a system whereby tobacco companies would have to pay penalties if they do not gradually reduce the number of people who smoke their cigarettes according to a schedule, with a required 90% reduction in smokers over the next 20 years. The penalties begin in 2015, and from 2015 through 2026, the companies must reduce the number of smokers of their brands by 33% from current levels, or else pay $3,500 for each smoker above the 33%. From 2027 on, the companies must reduce the number of smokers of their brands by 90% from current levels.

For example, there are about 45 million smokers today. In 2015, tobacco companies would have to reduce the number of smokers to 30 million. For each million smokers above 30 million in 2015, they would have to pay $3.5 billion. Thus, if the number of smokers in 2015 is reduced to only 35 million, the total penalty would be $17.5 billion. The penalties are adjusted for inflation, so the $17.5 billion would represent the penalty in current dollars, not 2015 dollars. The penalty is assessed annually, so if no progress were made from 2015 on, the companies would be paying $17.5 billion per year.

There are also three other very important aspects to the legislation:

1. Much stronger cigarette and smokeless tobacco warning labels would be required (such as "Smoking kills" and "Cigarettes cause fatal lung cancer"). In addition to the text warning, a color graphic depicting the negative health consequences of smoking and occupying at least 50% of the pack would be required.

2. The FDA would be given explicit authority to require the removal of nicotine from cigarettes and other tobacco products. This represents a very narrow scope of authority given to FDA. The FDA would not be given jurisdiction to regulate the overall safety of cigarettes. They would not be in the business of approving cigarettes for sale (other than approving their nicotine content).

3. States would be incentivized to spend significant portions of their Master Settlement Agreement funds for tobacco control programs. The legislation sets up a matching grant program under which states would receive matching grants if they spend at least 25% of their MSA funds for tobacco control programs. The additional grant would be 50% of any amount spent above 25% of the MSA payment, and could be used for additional tobacco prevention and cessation programs.

The Rest of the Story

It is a long time in the making, and the anti-smoking groups have been so obsessed with trying to achieve futile (and counter-productive) FDA regulation of tobacco products that they have squandered a golden opportunity to promote a federal tobacco policy that actually would make a dent in smoking, but Senator Enzi appears to be the first to have the right idea about what the federal government could and should be doing to control the problem of tobacco use in this country.

Senator Enzi is precisely on the right track, a track which has been eschewed by all the major anti-smoking and health groups because of their obsession with the deal that was essentially negotiated between the Campaign for Tobacco-Free Kids and Philip Morris (with Congressional mediation) two years ago.

In my media interviews over the past few weeks, I have repeatedly been asked what I think the federal government should be doing to control tobacco use, since I don't support the approach of regulating the safety of cigarettes and asking the FDA to approve this deadly product. In response, I have noted my opinion that if Congress sincerely wants to do something about reducing smoking rates, it will dedicate money to the one program which we know is effective in reducing both youth and adult smoking: state-of-the-art counter-advertising media campaigns.

Senator Enzi's proposal establishes what would be the first national tobacco counter-advertising program run by the federal government. It also provides incentives for states to use their Master Settlement Agreement dollars on smoking prevention and cessation programs, provides funding for state tobacco control programs, and increases the federal excise cigarette tax (which will itself reduce cigarette consumption) to pay for these national and state programs.

There are a few weaknesses in the legislation, which I have communicated directly to Senator Enzi's staff, which I feel would need to be addressed. One is a need to remove the provision that allows money to be spent on youth access programs, which have been repeatedly shown not to work. The second is a need to allocate a significant portion of the revenues derived from the penalties for smoking prevention and cessation programs.

But the basic idea behind the HEALTH Act is exactly where the federal government should be in terms of a national tobacco control policy. We should not be spending our precious time and resources in a futile effort to try to develop a safer cigarette, when the product contains over 4,000 chemicals and we have no idea which of those chemicals is responsible for the diseases caused by cigarette smoke. We should not be setting up a system by which the FDA grants its approval to deadly products. We should not be institutionalizing cigarette consumption nor granting unprecedented special protections to Philip Morris and other tobacco companies.

What we should be doing is to get serious about actually trying to reduce the demand for cigarettes. That is something which the federal government has never been serious about.

The HEALTH Act serves as a tremendously valuable contribution because it focuses attention in exactly the area it needs to be if we wish to ever have an effective and meaningful federal policy on tobacco control.

This is an embarrassment for the Campaign for Tobacco-Free Kids and its partners, because they were beaten to the punch by a Senator who they claim is a fraud when it comes to tobacco policy. Frankly, Senator Enzi appears to have a far more insightful, informed, and mature understanding of the direction the federal government needs to be going if it wants to develop an effective tobacco control policy that will actually make a difference in reducing smoking and saving lives, rather than merely shell out window dressing to be able to claim that it is doing something about the problem.

To call the FDA proposal window dressing is actually not appropriate, because the FDA bill is not merely ineffective, it is actually counter-productive and would undermine 40 years of tobacco control efforts in this country.

But what Senator Enzi's proposal reveals is not just the misguided nature of the FDA legislation, but also the failure of the anti-smoking groups to promote meaningful federal tobacco control policy. They have wasted precious time and resources and a rare window of opportunity. They have squandered a real opportunity to have made a difference in the public's health by obsessing with the FDA and the illusion of making cigarettes safer by removing some of their constituents, when the real progress is going to come only by reducing the demand for cigarettes, something which can be done only through a combination of cigarette taxation and allocation of revenue to tobacco prevention and cessation programs, especially counter-advertising.

Senator Enzi is right. These are the tried and true programs for smoking prevention.

The alternative to granting the FDA jurisdiction over tobacco products is not the status quo, as the Campaign for Tobacco-Free Kids and its partners have been suggesting. Actually, the alternative is to establish a meaningful and effective federal tobacco control policy by which we actually use the tried and true methods of reducing smoking: increasing cigarette price and implementing state-of-the-art national and state counter-advertising programs.

The problem is that not only have the Campaign for Tobacco-Free Kids and our other supposed leaders in tobacco control missed the boat to take a ship that is headed for disaster. Instead, they have prevented the correct boat from even coming.

Senator Enzi's proposal steers us in the right direction. Now is the time for the health groups abandon the absurdity of their obsession of the past two years. It is time to have a meaningful discussion about how the federal government can, for the first time, make a difference in the nation's number one public health problem.

No comments: