Thursday, May 22, 2008

FDA Bill is Result of a Negotiation Between the Campaign for Tobacco-Free Kids and Philip Morris; Revelation Threatens to Crumble Legislation

After carefully reviewing the evidence from a number of sources, including published articles and sources close to the process, I think it is clear that the FDA legislation currently before Congress is the result of negotiations that took place between the Campaign for Tobacco-Free Kids and Philip Morris, mediated by several members of Congress.

While it may or may not be the case that Tobacco-Free Kids and Philip Morris representatives were in the same room at the same time (at least one newspaper reports that such did occur), it hardly matters. The point is that the process that led to the development of the FDA legislation was essentially a mediated negotiation between these two parties.

This means that the compromises in the bill are present for the purpose of appeasing Philip Morris and retaining its support for the legislation. In other words, the loopholes in the bill are present in order to protect the financial interests of the tobacco industry. Thus, the Campaign for Tobacco-Free Kids has sold out the health of the American public in return for Philip Morris' support of the legislation.

This information, which may come as a revelation to many in the tobacco control field (because the Campaign for Tobacco-Free Kids has not been forthright about its negotiations with Philip Morris and has gone to great lengths to hide the process that led to the specific provisions in the legislation), is important because it demonstrates that the FDA legislation is a dream-come-true for Philip Morris: it is an opportunity to essentially let Philip Morris write the legislation by which its products will be regulated. No corporation could ask for any more.

It is entirely inappropriate to allow the regulated industry to be involved in the crafting of the legislation to regulate that industry. Public health laws should not be the result of a negotiation where we ask the regulated party to indicate what public protections it can and cannot support or live with.

I believe the public revelation of these facts may lead to the crumbling of this legislation. Why? Because I don't think this is something that the public can tolerate. In an era in which the FDA and other federal agencies are under intense criticism for the politicization of the regulatory process and the undue involvement of corporate lobbyists in the crafting of legislation and regulations, I don't think the public is going to tolerate the fact that the legislation which is supposed to end special protections for Big Tobacco (in the words of the Campaign for Tobacco-Free Kids) was actually developed through a negotiation with the biggest element of Big Tobacco: Philip Morris.

I have spoken to a number of people who work for groups which are supporting the FDA tobacco legislation who have told me that they were not aware that Philip Morris was involved in the development of this legislation and that if this news becomes public, it will be difficult for them to continue to support the legislation. What previously was a political asset will then be viewed as a liability.

The rest of the story is that the legislation which is billed as ending special protections for Big Tobacco is actually the result of a negotiation with Big Tobacco. Philip Morris participated in the crafting of the legislation, and in particular, the negotiation about the inclusion or exclusion of various specific provisions in the bill. These provisions sell out the public's health for the benefit of tobacco financial interests.

This is policy making at its worst: allowing the regulated industry to play a major role in the crafting of the legislation and its key provisions.

While I have not been able to convince many public health groups to oppose the legislation on its merits (or lack of merits, I should say) because there is disagreement in strategic judgment about the likely effects of the legislation on the public's health, there is very little disagreement in the tobacco control and public health communities that we should not formulate tobacco control policy by negotiating with Philip Morris to see what the nation's largest cigarette company finds acceptable or unacceptable.

To the best of my knowledge, there is only one tobacco control group out there which thinks it is acceptable to negotiate with Philip Morris to determine what policy provisions they can live with and what provisions are deal-breakers: and that's the Campaign for Tobacco-Free Kids. To the best of my knowledge, even the other organizations which are a central part of the coalition supporting the legislation were reluctant, if not completely unwilling, to sit down with Philip Morris at the negotiating table.

Now that the process that led to the legislation has come to public light, it is going to become increasingly difficult for those groups to defend their support of the process. Now that the process itself has been shown to be tainted, that taint extends not only to the Campaign for Tobacco-Free Kids - which is the only group which actually negotiated with Philip Morris - but also to the other groups supporting the deal. It becomes difficult for these groups to separate themselves from the stench of the process that led to the legislation. Supporting the bill means, to some extent, supporting or at least condoning the process that led to the legislation. And for most groups, that is simply not going to be possible any longer.

Regardless of any uncertainty about how anti-smoking groups will feel about this tainted process, it is clear to me how the public will feel. The public is going to think that the process stinks, as well they should. This is exactly the kind of special interest involvement in policy making that has become a major campaign issue during the present election cycle.

Public health groups should simply not be formulating tobacco control policy by sitting down with Philip Morris to figure out what public health protections the company is willing to live with. Policy should be formulated, instead, by sitting down with the rest of the public health community and developing the best possible legislation based on the evidence regarding best practices.

If compromise needs to take place, it should take place in an open forum, where all citizens can participate - at least through their elected representatives. It should not take place in a closed room negotiation that the public (and the rest of the public health community) is not aware of.


Here are excerpts from and links to some of the articles which document, provide evidence for, or conclude that the FDA tobacco legislation before Congress represents the result of a process of negotiation between the Campaign for Tobacco-Free Kids and Philip Morris, mediated by members of Congress:

1. Article from Roll Call, October 5, 2004:

"Moments after lawmakers unveiled landmark legislation last spring to impose the most sweeping regulations on cigarettes in history, two of the people most closely involved in the momentous compromise bumped into each other leaving a press conference on the deal. Though they were just a few steps from each other outside the Senate's television studio, Matt Myers and Mark Berlind didn't shake hands, embrace or even say hello. Instead, they moved silently past each other, carefully avoiding eye contact. Myers and Berlind may be the biggest winners if Congress approves the tobacco bill this week. But they're about as comfortable as boys and girls at a sixth-grade dance. It's easy to see why: Myers is the president of Campaign for Tobacco Free Kids, a group dedicated to outlawing smoking. Berlind is the chief legislative counsel for Altria Group, the parent of Philip Morris USA, the nation's leading cigarette maker. But the awkward encounter that day belies an uncomfortable alliance between the two men and their organizations that has helped to move the tobacco bill closer than ever before to the president's desk. In the next few days, Members of Congress will decide whether they will include the compromise tobacco bill in a corporate tax bill that they hope to approve by Friday. Thanks to separate but equally calculated decisions by Philip Morris and the Campaign for Tobacco Free Kids, each has broken ranks with their typical allies, formed a secret alliance and met clandestinely to iron out key sticking points on the legislation.

The talks between Philip Morris and the Campaign for Tobacco Free Kids took place on Capitol Hill
even as the two sides battled over a $200 billion Justice Department lawsuit in a federal courthouse a few blocks down Pennsylvania Avenue. The face-to-face negotiating sessions and conference calls were so sensitive that Philip Morris and the Campaign for Tobacco Free Kids refused to tell even their closest allies. Added Scruggs, a one-time aide to former Senate Majority Leader Trent Lott (R-Miss.): "It's far from an alliance. We have a commonality of interests in seeing the same piece of legislation enacted. They are working very hard in support of the same legislation that we happen to be working in support of." Despite the comments, Philip Morris and the Campaign for Tobacco Free Kids are well under the sheets on the tobacco bill. But getting them to take off their slippers took years. The seeds of today's coalition were planted years ago, when executives at Philip Morris and Tobacco Free Kids quietly made separate decisions about how they would deal with tobacco legislation in the future. ...

Philip Morris executives soon cautiously reached out to the company's longtime adversaries in the antismoking community, including Scott Ballin, a pragmatic antismoking advocate and former chief of the American Heart Association. Ballin had been searching for creative ways to move a tobacco bill through Congress. In a November 2001, Steven Parrish, the company's senior vice president for corporate affairs, sent a startling letter to Ballin in which he said Philip Morris wanted to talk to officials in the antismoking community about drafting a bill. Still, settling on specific language would prove to be difficult for Philip Morris and the antismoking advocates. The 2001-02 session of Congress ended without legislation. Last year also failed to bear fruit after Sen. Judd Gregg (R-N.H.) failed to forge a deal. But behind the scenes, a new player emerged who was able to bring the two sides together: Sen. Mike DeWine (R-Ohio). When Gregg called off talks in the fall of 2003, DeWine quietly reconvened negotiations. Led by aide Abby Kral, DeWine's staff pressed Philip Morris, the Campaign for Tobacco Free Kids, national health organizations and other stakeholders to come together on a bill. Complicating the process for DeWine was the fact that few antismoking officials would agree to negotiate with Philip Morris. "There is just no benefit to working with them," said Paul Billings, the vice president of national policy at the American Lung Association. "They still are an evil company. They nearly sell more cigarettes than all other cigarette makers combined." Unbeknownst to their allies in the public health community, representatives of the Tobacco Free Kids spoke with Philip Morris lobbyists several times and met at least once to iron out language that both sides could accept. Both sides say most of the talks were arranged by DeWine's office because officials from Tobacco Free Kids and Philip Morris felt uncomfortable dealing with each other. Several times, however, Myers spoke directly to Philip Morris officials either face-to-face or by phone. "I believe there was at least one meeting with multiple parties present where both sides were there," said Myers. Even the talks over the telephone could be awkward at times. Because neither side wanted to initiate phone calls to the other, Philip Morris and Campaign for Tobacco Free Kids officials relied on intermediaries to set up conference calls so they could talk directly. Despite the difficulties, both sides say the direct talks were helpful."

2. Article in Tobacco Control, 2007, Volume 16:

"But how has Philip Morris attempted to implement these multiple policy goals? One key element of this campaign has been "constructive engagement" with key health groups and advocates. The beginning of this highly unusual effort by Philip Morris began in November 2001 when secret negotiations, of which many health advocates were unaware, were initiated between Philip Morris and the Campaign for Tobacco-Free Kids. In 2003, after a temporary impasse, these secret negotiations were reconvened by US Senator Mike Dewine (Republican, Ohio). A compromise was eventually struck that led in 2004 to the introduction in the US Senate of an FDA tobacco regulation bill by Senators Edward Kennedy (Democrat, Massachusetts) and Mike Dewine (Republican, Ohio)."

3. Op-Ed by Scott Ballin, The Hill, July 24, 2007:

"Unfortunately however, the process that has been followed in Congress thus far has stymied dialogue and engagement. In the case of this legislation, a backroom agreement between Philip Morris and the Campaign for Tobacco Free Kids seems to have been concluded even before the legislation was officially introduced — making moot any comprehensive substantive hearings and suggested changes. The agreement, while understandable in some ways, is far from being transparent and reflective of open and deliberative government. It fails to provide opportunities for discussion about how the legislation can be improved."

4. Tobacco Control Article, 2006, Volume 15:

"In 2003, despite its previous differences with CTFK, PM reportedly negotiated with CTFK representatives to achieve mutually acceptable terms for FDA legislation."

5. PR Watch Article:

"After all, PM [Philip Morris] has a corporate mandate to increase profits for its shareholders, so PM would not support this legislation if it wasn’t going to benefit its bottom line, and it is practically an axiom in public health that whatever benefits PM’s bottom line is going to be bad for public health. That’s what makes this bill especially troubling to people who study tobacco industry documents; it is clear that PM had a hand in crafting it. That alone sounds like a lot, but PM's efforts to enact it are clearly delivering the company a hefty side-benefit of causing dissent within the tobacco control community over its passage. Neither the content of the bill nor the strident disagreement about it among tobacco control professionals is happenstance. ...

PM approached the National Campaign for Tobacco-Free Kids (CTFK) seeking input to formulate its preferred FDA regulations. As the Plan mentioned, PM found common ground with CTFK on the youth smoking issue, and engaged CTFK in its Regulatory Strategy Project to craft FDA regulations in its favor. Now CTFK is helping PM stump for passage of a bill that many highly experienced tobacco control people and organizations consider deeply flawed in many respects. An article in the October 5, 2004 edition of Roll Call, the newspaper of Capitol Hill, titled "How Philip Morris, Tobacco Foes Tied the Knot," describes the uncomfortable first meeting between Matt Myers, President and Chief Executive Officer of the Campaign for Tobacco Free Kids, and Mark Berlind, Associate General Counsel of Philip Morris, and the subsequent secret negotiations the two parties carried on without notifying others in the tobacco control community. ...

That the current FDA bill was created through secret negotiations apparently orchestrated by PM certainly seems to be the case. No other public health entities with exceptional experience in tobacco control were asked to participate in formulating the proposed regulations -- no current or former Surgeons General, no one from the American Association of Public Health Physicians, none of the many prominent longtime public health advocates around the country with decades of experience fighting the tobacco industry, and no public health advocacy groups that have detailed knowledge of tobacco industry strategies or the best track records of success in reducing public smoking, like Americans for Nonsmokers Rights or the state Groups to Alleviate Smoking Pollution (GASPs). No scholars in tobacco industry documents or tobacco policy were invited. The amount of valuable tobacco control expertise and knowledge that was summarily excluded from the negotiations to create the bill is amazing--and highly suspect.

CTFK ducked questions about the "secret negotiations" claims and instead steered us to "FDA" section of their Website and suggested we contact the Senate sponors of the bill for comment. The American Cancer Society, which has been fighting tobacco for decades, declined to comment when asked how they felt about being excluded from the negotiations."

6. Campaign for Tobacco-Free Kids Press Release, October 2, 2003:

In this press release, entitled "Tobacco Bill Negotiations Failed Due To Loopholes Sought By Tobacco Industry," the Campaign for Tobacco-Free Kids itself admits that there were indeed ongoing negotiations with Philip Morris to try to achieve a deal on FDA tobacco legislation: "In a statement released late Wednesday, Philip Morris claimed that negotiations over proposed legislation to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products “have broken down due to the last-minute insistence that the FDA be given the power to ban the sale of all cigarettes to adults.” This statement is completely false, and Philip Morris knows it. The negotiations were not about whether the FDA should be permitted to ban cigarettes or other tobacco products. ...

The fact that this offer was dismissed out of hand is a clear indication that Philip Morris and some in Congress wanted to tie the FDA’s hands in requiring any changes in tobacco products, not just to prevent FDA from banning cigarettes. Rather than accept the compromise language we offered, some in Congress insisted on the inclusion of ambiguous language in the section entitled Powers Reserved to Congress that would have allowed the tobacco industry to challenge FDA efforts to require the removal of known harmful substances from current tobacco products. ... "The negotiations broke down..."

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