86) But a Dear Doctor letter providing truthful, impartial information about both brand and generic formulations would pose no risk of false or misleading communication.
This Petition Clause analysis was uncontested before the Court and is unrelated to the validity under the Free Speech Clause of the FDA's interpretation of its Dear Doctor letter regulations.
Finally, and critically for purposes of this Comment, the plaintiffs mounted a separate argument: that the generic manufacturers could have employed so-called Dear Doctor letters (28) to "send additional warnings to prescribing physicians.
Indeed, the plaintiffs' merits brief did not once refer to the regulation that, in the FDA's view, brought Dear Doctor letters under the "labeling" regulatory regime.
If the First Amendment forbids the FDA's interpretation regarding Dear Doctor letters, a more principled route for recovery exists.
The Court in Mensing accepted the FDA's interpretation that generic manufacturers may not send Dear Doctor letters to inform physicians of possible risks.
The Mensing plaintiffs did not contest the FDA's interpretation regarding Dear Doctor letters in any meaningful way-and they could not have known that the Court in Sorrell would offer such a robust First Amendment ruling.