Congress Grants FDA Oversight
of Tobacco Products

Guess who's Coming to Dinner?

by: Phillip Gardiner, Dr. P.H.

In a much anticipated and often criticized move the United States Senate on a vote of 79 to 17, turned a deaf ear to the pleas for mercy from North Carolinian Senators, and passed the Kennedy sponsored bill, S 982, on Thursday June 11, 2009 giving the Food and Drug Administration (FDA) oversight of tobacco products. The very next day, the House followed suit and passed the same legislation, by-passing the usual Senate/House conference committee negotiations, sending the bill directly to the desk of President Barack Obama, who in an elaborate Rose Garden ceremony signed this bill into law on June 22nd, 2009. The drama of FDA oversight of tobacco products has riveted the tobacco control movement for over a year now. There are those who argue that it is a complete sellout (1). On the other hand, there are others who argue that it is the best that we could do at this time (2). Burning Issues has devoted much ink to this issue in voicing our own concerns about the legislation. In October of 2007 we reviewed the Bill in detail: FDA at the Crossroads, by M.F. Bowen, which identified the many benefits in the legislation for Philip Morris’ (3). Then again in October 2008 we ran an article: Menthol Moves Center Stage, by Phillip Gardiner, which exposed the weakness of the bill on the question of Menthol and detailed the hard work that was necessary to get the House Bill amended, moving the question of menthol to the very top of the of the FDA’s Scientific Advisory Committee’s agenda (4). For this issue we want to focus on The Scientific Advisory Committee itself and what may be one of the more egregious problems with this legislation: the invitation to the tobacco industry to participate and sit on the Scientific Advisory Committee. How is it that the tobacco industry was allowed to be part of the oversight for tobacco control? Why are they invited to dinner? What can be done to mitigate this unseemly situation?

Who’s driving this bus anyway?

This new legislation allows the FDA to establish a Center for Tobacco Products within the FDA. In turn this new center would be overseen by a 12-member Scientific Advisory Committee that would be appointed by Kathleen Sebelius, Secretary of Health and Human Services. Astonishing, though is the fact that 3 of the 12 seats are “reserved” for representatives from the tobacco industry (yikes!). Talk about the fox being put in charge of the hen house. Mincing no words, the legislation states: The committee shall be composed of—

“(i) 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;

(ii) 1 individual who is an officer or employee of a State or local government or of the Federal Government;

(iii) 1 individual as a representative of the general public;

(iv) 1 individual as a representative of the interests of the tobacco manufacturing industry;

(v) 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee; and

(vi) 1 individual as a representative of the interests of the tobacco growers.” (5)

And while the legislation makes it clear that this gaggle of industry representatives will not be voting members, having the fox in on the discussions of the hens is extremely problematic. While the above representation methodology is generally used in appointing FDA Scientific Advisory committees, there are some significant differences when we consider the tobacco industry.

In the first place, the tobacco industry are convicted racketeers! In August of 2006, a Federal Court found the tobacco industry guilty of racketeering and corrupt business practices, or said another way, guilty of being themselves (6). As expected the tobacco industry appealed this ruling, buying time and space to continue their anti-health machinations. But, even the 9th District Court of Appeals saw through the industry’s deceptions and has upheld the ruling (7). It is unfortunate that the both the United States Senate and House of Representatives didn’t follow the lead of the judiciary branch and just kick these gangsters to the curb.

However, even more problematic, by placing members of the tobacco industry on this Scientific Advisory Committee, the United States finds itself in violation of the Framework Convention on Tobacco control (FCTC), the singular agreement of the international tobacco control movement. Article 5.3 of the FCTC states clearly that: “In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law” (8). Indeed, the world tobacco control movement felt so strongly about article 5.3 that they wrote guidelines for its implementation, a 12 page long pamphlet (9). While not reviewing each and every suggestion, the following guideline goes right to the heart of the matter:

“Principle 1: There is a fundamental and irreconcilable conflict between the tobacco
industry’s interests and public health policy interests.

13. The tobacco industry produces and promotes a product that has been proven scientifically to be addictive, to cause disease and death and to give rise to a variety of social ills, including increased poverty. Therefore, Parties should protect the formulation and implementation of public health policies for tobacco control from the tobacco industry to the greatest extent possible (9).”

If the United States actually gets around to signing the FCTC, it would automatically be in violation of article 5.3; a terrible precedent for tobacco control in the United States and worldwide. Allowing the tobacco industry to have a voice on the scientific advisory committee would allow them to continue to obfuscate and muddy the issue. It is unfortunate that the crafters of the legislation didn’t take the advice of the FCTC, because placing the tobacco industry on the key scientific oversight committee will not protect the formulation and implementation of public health policy, it will produce just the opposite.

And yes, unfortunately the tobacco industry will be the driver of the tobacco control bus. This is nothing new, You guessed it: the industry has a history of doing just this same thing.

History should be our guide

While industry representatives will participate on the Scientific Advisory Committee as nonvoting members, there is significant negative historical precedent that makes a very strong case for excluding tobacco industry representatives from this committee. In 1968 the National Cancer Institute (NCI) created the Tobacco Working Group (TWG), which included health experts and tobacco industry representatives, to advise its Smoking and Health Program (10), similar to the current FDA authority. Additionally, tobacco industry representatives on that body were non-voting members, again similar to the current requirements of the FDA Scientific Advisory Committee.

Not only did the tobacco industry scientists effectively influence the course of research activities of the NCI, they gave the industry a crucial insider position to keep an eye on the direction in which the NCI’s Smoking and Health Program was going. Federal District Judge Gladys Kessler summarized how the industry used its TWG membership in her 2006 ruling that Philip Morris and other elements of the tobacco industry violated the federal Racketeer Influenced and Corrupt Organization (RICO) Act: “Participation by industry representatives proved valuable [to the industry] by allowing Defendants to keep abreast of what the United States Government was doing with respect to smoking and health issues. Their participation also provided a mechanism by which defendants could try to influence the United States Government’s activities in the smoking and health area. … The [racketeering] Enterprise engaged in a concerted effort to prevent, curtail, and ultimately to neutralize the TWG’s efforts to evaluate cigarettes’ [health] effects using an animal bioassay … (6)”

In essence, the tobacco industry’s racketeering conviction stemmed in part from abusing their position on the TWG. This is exactly the same thing that they are attempting to do by being placed on the FDA Scientific Advisory Committee. Sharon Eubanks, the lead prosecutor for the government in the RICO case along with tobacco control expert and UCSF professor Stanton Glantz have suggested that language quoted above and other parts of/ from Judge Kessler’s ruling should have been added to the FDA Bill. Moreover, Judge Kessler found that not only had the industry engaged in these illegal practices in the past, but that they were continuing to do so and likely to continue to do so in the future (6). This finding has now been upheld on appeal giving the industry no leg to stand on. Hence, given the past, current and probable future practice, there should be no question; the tobacco industry should definitely not have a seat at the table.

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Tobacco Industry Representation: By any means necessary

Then as if to add insult to injury, a representative of tobacco growers is slated to become a member of the FDA Scientific Advisory Committee (5). Why this is so outlandish is that the FDA authority that was passed explicitly states that the FDA will not have any jurisdiction over tobacco farming, tobacco growing and tobacco production! The proposed law specifically excludes regulation of tobacco leaf not in the possession of a manufacturer of tobacco products. The language is specific:

“(2) LIMITATION OF AUTHORITY-

IN GENERAL- The provisions of this chapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer”(11).

Clearly, the industry’s influence was so great in the crafting of this legislation that they were able to get seats at the table for tobacco farmers, who were unambiguously excluded for FDA oversight; talk about inviting uninvited guests to dinner.

A cautionary note as we move forward

Denunciations and recriminations have been voiced by many in the tobacco control movement concerning the many weaknesses in the FDA Bill. The tobacco control movement must admit having representatives of the tobacco industry as part of the FDA’s scientific oversight of tobacco is clearly problematic. If it was necessary in 2006 under the pro-tobacco Bush administration to include these scoundrels in the legislation, that’s one thing. But it is a whole other thing to maintain this arrangement and other parts of the legislation given the regime change in Washington. On the other hand, the tobacco industry’s placement on the scientific oversight committee is a testament to their considerable political strength and the relative weakness of the tobacco control movement. While those negotiating this deal certainly could have fought harder, the fact remains that the tobacco control movement lacked the political acumen and/or clout to restrict the participation of the tobacco industry. There are many advances for the tobacco control movement contained in the FDA legislation, still it is quite sobering to realize that the tobacco industry- even after their racketeering conviction – squarely in opposition to the FCTC – and we all have knowledge of their past practices, that this industry was again invited to dinner and allowed a seat at the table.

But let’s not wring our hands. There is a bold proposal out there put forward by the National African American Tobacco Prevention Network (NAATPN) that says that the tobacco control movement should come together and form a committee to oversee the work of the FDA Scientific Advisory Committee. Instead of just a few select groups determining what happens, as was the case in the crafting of this legislation, let’s gather representatives from across all sectors of the tobacco control movement to monitor the work of this scientific advisory committee and the broader tobacco work of the FDA. Yes, if the foxes are at the table then, someone (none dare call us dogs) must oversee what exactly what the foxes are doing.

The NAATPN proposal grew out of discussions between tobacco control advocates and researchers around the country who were concerned (to put it mildly) about the legislation. Specifically, following the all the hard work around getting the menthol amendment (See Burning Issues, Menthol moves Center Stage, 2008) it was determined that oversight of the FDA process around menthol could not be left to the proposed tobacco industry tinged Scientific Advisory Committee. With language that states in part that the first order of business for the scientific advisory committee is to determine “the impact of the use of menthol in cigarettes on the public health including such use among African Americans, Hispanics, and other racial and ethnic minorities” (12.), there was no confidence by NAATPN and others that this committee would carry out its task.

While the tobacco control movement might not be able to alter the current make up of the FDA Scientific Advisory Committee, we can not only demand representation on the committee itself, but establish a broad coalition of forces to serve as watch-dogs over the process itself. This whole episode highlights that as a movement we are still not strong enough to keep the tobacco industry from coming to dinner. But we must remain vigilant, for when we take up the next major fight, possibly about FCTC ratification or banning menthol, we may find ourselves in a position to thwart the machinations of the tobacco industry and deny them a seat at the table.

References

1. Siegel, M. “Tobacco regulations are no regulations at all.” Los Angeles Times Opinion, Une 3, 2009; http://www.latimes.com/news/opinion/commentary/la-oe-siegel3-2009jun03,0,1905325.story

2. Campaign For Tobacco Free Kids. “FDA authority over tobacco; Congress votes to protect kids, save lives.
Campaign for Tobacco Free Kids website, June 12, 2009; http://www.tobaccofreekids.org/reports/fda/?utm_source=carousel&utm_medium=carousel-&utm_campaign=fda_passage

3. Bowen, MF. “FDA at the Crossroad.” Burning Issues, Tobacco-Related Disease Research Program (TRDRP) Newsletter, Vol. 9 No. 3, October 2007; http://www.trdrp.org/publications/newsletters/2007/1007newslttrprnt.pdf

4. Gardiner, P. “Menthol Moves Center Stage.” Burning Issues, Tobacco-Related Disease Research Program (TRDRP) Newsletter, Vol. 10 No. 2, October 2008; http://www.trdrp.org/burningIssues/1008/BurningIssues-menthol1008.asp

5. U.S. Congress (House and Senate). “Family Smoking Prevention and Tobacco Control Act.” Tobacco Products Scientific Advisory Committee, Sec. 917 (a) (A) (i) – (vi); Library of Congress, June 18, 2009; http://thomas.loc.gov/cgi-bin/query/D?c111:6:./temp/~c111g0ZasW::

6. Banthin, C., Daynard, R., & Guardino, S. “USA vs Philip Morris USA, Inc., et al.: Analysis of Judge Kessler’s Opinion and Order;” November, 2006; Tobacco Control Resource Center’s web site. http://www.tobacco.neu.edu/

7. Scarcella, M. “Appeals Court Upholds Landmark RICO Case Against Big Tobacco.” The BLT: The blog of Legaltimes, Friday May 22, 2009; http://legaltimes.typepad.com/blt/2009/05/appeals-court-upholds-landmark-rico-case-against-big-tobacco.html

8. World Health Organization. “WHO Framework Convention on Tobacco Control.” World Health Organization, Article 5, General Obligations, Section 3, adopted 2003; http://www.who.int/fctc/text_download/en/index.html

9. World Health Organization. “Guidelines on the protection of public health policies with respect to tobacco control from commercial and other vested interests of the tobacco industry (guidelines for implementing Article 5, Section 3 of the Framework Convention on Tobacco Control); http://www.who.int/fctc/guidelines/article_5_3/en/index.html

10. Glantz, S. Barnes, R. Eubanks, S. “The FDA or not the FDA: That is not the Question.”
Unpublished Manuscript, 2009.

11. U.S. Congress (House and Senate). “Family Smoking Prevention and Tobacco Control Act.” Tobacco Products Scientific Advisory Committee, Sec. 901 (2) (A) Library of Congress, June 18, 2009; http://thomas.loc.gov/cgi-bin/query/D?c111:6:./temp/~c111g0ZasW::

12. U.S. Congress (House and Senate). “Family Smoking Prevention and Tobacco Control Act.” Tobacco Products Scientific Advisory Committee, Sec. 907 (e) (1) Library of Congress, June 18, 2009; http://thomas.loc.gov/cgi-bin/query/D?c111:6:./temp/~c111g0ZasW

Congress Grants FDA Oversight of Tobacco Products

Congress Grants FDA Oversight
of Tobacco Products