MO v. FDA: DEFENDANTS’ REPLY IN SUPPORT OF THEIR MOTION TO DISMISS, OR IN THE ALTERNATIVE, FOR SUMMARY JUDGMENT, Feb 10, 2016February 12, 2016 10:36 am by Gene Borio
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Plaintiffs’ pre-enforcement, facial challenges to a guidance document issued by the United States Food and Drug Administration (FDA) are not ripe because the guidance document does not represent final agency action and Plaintiffs have not shown that they will suffer significant hardship if review is withheld. Even if Plaintiffs’ claims are ripe for review, the Court should grant summary judgment to Defendants. The guidance document sets forth reasonable interpretations of the Family Smoking Prevention and Tobacco Control Act (“TCA”), which harmonize the TCA’s structure and text and further its core purposes. Because the guidance does no more than advise the public of the agency’s interpretation of the statute it administers, it is not a substantive rule, and Plaintiffs’ procedural challenges to it are meritless. Finally, Plaintiffs’ constitutional challenges to the FDA’s interpretation of the TCA regarding label changes that render a product distinct should be rejected because the agency’s interpretation of the statute does not violate the First or Fifth Amendment. For all of these reasons, the government’s Motion to Dismiss, or in the Alternative, For Summary Judgment should be granted.
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Finally, the government previously explained that FDA has not pursued a single civil or criminal enforcement action related to distribution of a new tobacco product without premarket review, has not issued a Warning Letter to any of the Plaintiffs related to any issue addressed in the Guidance, and, under the agency’s regulatory enforcement policy, ordinarily gives firms the opportunity to correct violations voluntarily “prior to the initiation of enforcement action.” Plaintiffs respond only that the fact that FDA “may choose to exercise its discretion to give manufacturers a chance to correct violations does not mean that FDA will always do so or that the threat of enforcement is any less real.” But Plaintiffs have offered no basis for presuming, on a facial challenge, that FDA will depart from its ordinary practices and policies.
For the reasons set forth above and in our opening brief, Defendants’ Motion to Dismiss, or in the Alternative, for Summary Judgment should be granted, and Plaintiffs’ Motion for Summary Judgment should be denied.