- FAMRI Center
FDA needs to understand and integrate the Findings of Fact from the RICO case against the tobacco companies in its deliberations
Judge Gladys Kessler’s ruling that the major cigarette companies formed an illegal “enterprise” to defraud the public and that those efforts to defraud the public are continuing and likely to continue in the future, provides an amazingly well-documented (and, surprisingly, readable) history of the tobacco industry activities over more than a half century, including, in particular, how the tobacco companies sought to manipulate scientific discourse and the policy making process. These issues are of central importance to the FDA in deciding how to interact with the tobacco industry.
Yet, in the many discussions with people at the FDA I have been astonished that, while they are generally aware of the decision, no one seems to have actually read it or the DC Court of Appeals decision upholding Judge Kessler’s Findings of Fact.
While some of the decision deals with legal technicalities (such as why the Racketeer Influenced Corrupt Organization Act applies) and the nature of the remedy, much of the 1683 page decision represents carefully documented factual conclusions with citations to specific supporting evidence.
Significantly, Judge Kessler reached these conclusions after an 8 month trial in which the defendant cigarette companies had every opportunity to challenge the Department of Justice’s allegations.
And, in upholding Judge Kessler, the Court of Appeals cited the companies’ ongoing manipulation of the scientific process as particular evidence that the racketeering activities are continuing.
It is true that people at the FDA a generally aware that the decision exists, but there is an amazing lack of understanding of the detailed substance of Judge Kessler’s decision.
It is time that the FDA formally and publicly engage the detailed substance of these Findings of Fact.
To do so, the FDA needs to hold a multi-day public meeting in which the Department of Justice presents the Findings of Fact that are relevant to the FDA’s regulatory responsibilities, together with the most relevant supporting evidence.
Among the relevant issues are:
- Most important, manipulation of the scientific process to perpetuate the fraud
- How the defendant companies used their position as members of the National Cancer Institute’s Tobacco Working Group for intelligence gathering and to manipulate the government
- Manipulation of nicotine
- Marketing to youth
Most important, high level leaders from all sections of the FDA involved in decision making about tobacco policy should attend this meeting, including the Office of Regulatory Affairs, General Counsel, Office of Policy and Planning, Office of Compliance and Enforcement, and, of course, the Center for Tobacco Products, so that they can learn about and integrate the substance of these findings into the FDA’s processes.
Once the FDA masters this information, it should become routine to include the relevant Findings of Fact into all proposed regulations, guidance documents, and other publications. These facts are as well vetted – probably better vetted – and relevant to regulation of tobacco products as any scientific paper.
The purpose of this meeting is not to re-litigate the case or add anything beyond the ruling, but rather to help the FDA determine how to use the results of the Department of Justice’s massive, decade-long effort into the FDA’s regulatory decision making process. including how to interact with the tobacco companies and the information they present in their efforts to influence the FDA.
The meeting could include a period for public comment (yes, including the tobacco companies), but the sole formal presenter should be the Department of Justice.
The facts, ma’am. Just the facts.