On September 17, 2008, Wyeth filed its reply brief in Wyeth v. Levine, No. 06-1249, in which it continues to insist that it could not comply with both federal prescription drug regulations and any state-based common law duties to warn. Wyeth Reply Brief.
Wyeth’s regulatory argument continues to strain credulity. Indeed, Wyeth persists in torturing the plain text and meaning of the 21 C.F.R. § 314.70 (dealing with “Changes Being Effected” supplements), and more specifically, continues to skirt 21 C.F.R. § 314.70(c)(6)(iii)(A) (permitting labeling changes to be distributed without FDA approval). Remarkably, Wyeth manages to almost wholly avoid even mentioning subsection (c)(6)(iii), notwithstanding that the very first subsection of its brief purports to focus solely on the permissibility of manufacturers’ “unilateral” labeling changes. And tellingly, although Section I.A. of the brief advances Wyeth’s position that no labeling changes can be effectuated without FDA approval, the very title of the subsection belies Wyeth’s confidence in the argument: “Federal Law Generally Prohibits Unilateral Changes To FDA-Approved Labeling.” Wyeth Reply, at 4 (emphasis added).
Rather than rebutting plaintiff’s position by examining the actual text of (c)(6)(iii), and arguing, for instance, for a contrary interpretation, Wyeth artfully attempts to shift the focus to a second-hand source: the FDA’s pronouncements concerning the labeling process, as contained in the Federal Register. Indeed, almost the entirety of Wyeth’s argument that the regulations do not permit unilateral labeling changes (appearing in section I.B of the reply) avoids any mention of the actual text of Section 314.70. In approaching the argument this way, Wyeth commingles positive law (FDA regulation) with a source that is not law at all – the FDA’s position on the meaning of that positive law. Wyeth neatly covers its tracks here by harkening immediately, albeit loosely, to the notion of deference, but in doing so, ignores the salient and obvious principle that deference to an agency’s position on the meaning of that agency’s regulations can only be as strong as the position is colorable. Even if the FDA’s commentary, in legal briefing and in the Federal Register, amounts to interpretation of Section 314.70 such that unilateral warning is not permitted by the regulations, it is impossible to reach that conclusion if one reads the actual text.
Moreover, in its only acknowledgment of Section 314.70(c)(6)(iii), see Reply, at 7, Wyeth correctly concedes that the regulation permits a prescription drug manufacturer to effectuate a labeling change upon the submission of a supplement to the FDA. However, Wyeth wrongly states that the FDA is “required” to approve such a submission. To the contrary, there is absolutely no provision in subsection (c) that mandates any FDA action, either approval or disapproval. Why does this matter? It matters because, in essence, Section 314.70 is the center of the prescription drug, post-approval labeling universe. Once a drug is approved by the FDA, the only federal labeling standards to which manufacturers traditionally have been held manifest in that section of the regulations. As such, Section 314.70 is the most pertinent and instructive piece of federal positive law to examine when asking whether a state common law duty to warn might “impliedly conflict” with federal law, and nowhere in that section is there any evidence of a tangible roadblock to the operation of such a common law duty.