Tobacco Corporate Compliance

3-03-1997 6:42AM FROM P.4 Tobacco- Capacak ISSUES IN SECTION 224: ACCOUNTABILITY PANEL Corporplance Summary. The primary and extremely serious problems created by this proposal are the following: I. This provision has the potential to gut the look back and assessment provisions of the Act. II. The role of the Food and Drug Administration and its Commissioner is confounded with the Commissioner's role at the head of this Panel in ways that threaten the FDA's traditional regulatory functions. III. The operation of the Panel will require the creation of a new and cumbersome bureaucracy. Discussion. I. Section 224 shifts from the manufacturers to the Panel the obligation to prevent and excuse non-achievement of the companies' youth tobacco use reduction goals. A. The bill obligates the Panel to approve a manufacturer's plan to meet its goals or to recommend amendments to the plan to achieve the goals. Thus, a manufacturer can rely on having gotten a "pass" from the Panel or having agreed to the amendment of its plan as suggested by the Panel as an endorsement that its efforts to meet its goal are adequate. Indeed, Section 224(e) states that compliance with Panel recommendations must be a consideration in determining whether the manufacturer made "reasonable efforts" to meet its look back goals. We don't yet have the full language of Sections 201 and 202, but the import of Section 224 appears to be that Panel acquiescence provides a defense for failure to meet look back targets.. B. Sections 224(d) and (e) speak to those look back targets directly. Subsection (d) requires the Panel (made up of the Surgeon General, a CDC representative and the Director of the HHS Office of Minority Health) to report to the Commissioner of FDA, as Panel head, the "danger" that a manufacturer will not attain its youth tobacco use reduction target. [A "miss" by any amount appears to trigger this notification.] The Commissioner must then commence a court action seeking suspension of the manufacturer's liability protection. The Secretary must prove, in that action, that there is a danger of the goal being missed [by even a very small percentage], and if the court so finds, it may suspend the defendant's liability protection. One irony of this process is that within a year after such litigation is begun, the results of a yearly survey will reflect whether the target at issue was actually missed. If it was not, the litigation may drag on nonetheless, since the question at issue may be whether the suit was well founded when filed, not whether the target was actually missed.