As we previously reported here, on September 5, 2018, the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes, as set forth in the 2009 Tobacco Control Act. The Court ordered FDA to provide an accelerated timeline for the completion of its rulemaking. On October 5, 2018, FDA provided the Court an accelerated schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021 (six months sooner than FDA’s initial, estimated timeline of November 2021).
The plaintiffs, largely comprised of public health organizations such as the American Academy of Pediatrics, American Cancer Society, American Heart Association, and the American Lung Association, among others, were asked to submit a response. In a response submitted on October 17, 2018, the plaintiffs contended that FDA’s proposed schedule “shows that the agency continues to act with no sense of urgency even while it trumpets, as it should, the massive adverse public health consequences associated with smoking and the importance of the graphic warnings Congress mandated in 2009.” Accordingly, the plaintiffs urged the court to reject FDA’s proposed schedule and issue an order for an expedited schedule that would result in a Final Rule to be submitted for publication in the Federal Register by January 31, 2020. The plaintiffs urged the Court to establish firm deadlines for FDA’s completion of each of the remaining steps of its rulemaking. In addition, the plaintiffs pushed for the court to require FDA to notify the plaintiffs no later 45 days before each of these milestones if FDA has any reason to believe that it will be unable to comply with a court-ordered deadline.
Now, as the plaintiffs await a court order establishing an expedited schedule for the completion of FDA’s rulemaking, the plaintiffs contend that FDA has continued to take a “business as usual” approach and has not moved significantly on the rulemaking, other than by publishing an Experimental Study Notice on September 26. In a recent motion filed on December 21, 2018, the plaintiffs again urge the Court to “promptly and explicitly order” FDA to complete each of the remaining steps in its rulemaking by fixed deadlines. It will be interesting to see whether the Court decides to further advance what the Agency considers an already “accelerated” deadline consistent with the plaintiffs’ requests.