On Wednesday, I spoke on a panel at the Food & Drug Law Institute’s FDA Regulation of Tobacco Products Conference. I provided an update on two pending lawsuits involving industry challenges to FDA’s tobacco-related actions. (My slides, as well as those of the other presenters, can be downloaded from the conference link.).

The first case, Lorillard v. FDA, involves a challenge to the composition of the Tobacco Products Scientific Advisory Committee (TPSAC). The plaintiffs, Lorillard and R.J. Reynolds (now the same company), alleged that some members of TPSAC should have been disqualified from serving on the committee because (a) they had testified against tobacco companies in court, and (2) they had consulting relationships with pharmaceutical companies that produce smoking-cessation products. The District Court judge (Judge Leon) agreed with the tobacco companies, but the case is currently on appeal. The D.C. Circuit heard oral arguments a few weeks ago and requested supplementary briefing on issues of standing and ripeness.

As I discussed, what jumped out at me in reviewing this case was this somewhat remarkable admission from the plaintiff tobacco companies:

Manufacturers of nicotine-replacement-therapy products and other smoking-cessation products . . . are in direct competition with tobacco-product manufacturers for the purchasing choices of adult smokers.

This statement is remarkable because the tobacco industry has publicly (though not very credibly) claimed for years that whether someone chooses to quit smoking is none of its concern. It claims that its advertising efforts are all focused on promoting brand switching for adults who have made the decision to smoke, rather than recruiting new smokers or dissuading people from quitting. The statement quoted above, however, is a straightforward admission that these companies are in the business of keeping current smokers smoking.

As for the case itself, it raises much broader issues for the FDA. The FDA has 50 different advisory committees (and, by the way, is looking for new members). If plaintiffs can use litigation to second-guess appointments to advisory committees (not participation in particular matters, but just the mere fact of appointment), it would be extremely problematic for the agency. Likewise, if the FDA is barred from appointing people with relevant consulting roles or who act as expert witnesses, it would dramatically thin the pool of people who can be on advisory committees. In general, the FDA wants/needs access to the same expertise that has led people to be selected as consultants and expert witnesses.

The second case I discussed, Philip Morris v. FDA, is a challenge to an FDA guidance document relating to the substantial equivalence (SE) review process. The plaintiffs – Philip Morris, R.J. Reynolds, and Lorillard – claim that changes to the label of a tobacco product or changes in quantity should not be required to undergo any FDA oversight, because these are not really changes to the product itself. They also claim that the requirement for premarket review of label changes violates the First Amendment.

I believe the FDA has the stronger argument on the merits, but I expect the FDA to move to dismiss this case on the basis that guidance documents are non-binding statements of policy and cannot be challenged. The plaintiffs have tried to anticipate that argument, suggesting that the guidance is really a regulation in disguise and it should have gone through the notice-and-comment rulemaking process. This argument, in my view, misses the mark. The plaintiffs believe that the guidance is imposing new legal requirements (requiring SE review of label and quantity changes) only because they disagree with the FDA’s interpretation of the underlying statute. According to the FDA, it is the Tobacco Control Act itself that imposes these requirements; the guidance merely outlines the FDA’s planned process for implementing them in a more permissive way than the law requires. The irony of this lawsuit is that the FDA’s guidance outlines a streamlined pathway for SE review of labeling and quantity changes as an alternative to the more cumbersome regular SE process. The FDA thought it was doing the tobacco industry a favor – instead, it got hauled into court.

@micahlberman