By Rebecca Mayo, J.D.
A district court held that the FDA unlawfully withheld or unreasonably delayed promulgating a Final rule that it has been working on for five years and claims to need another three years to complete despite being given a two year deadline by Congress. The court held that a court decision vacating an agency’s Final rule resets the time clock but does not eliminate the requirement for the agency to act within the time originally designated by Congress (American Academy of Pediatrics v. FDA, September 5, 2018, Talwani, I.).
First final rule. The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) (P.L. 111-31) directed the FDA to promulgate color graphic warnings to be placed on cigarette packaging by issuing a new rule within two years of enactment or by June 22, 2011. On the exact deadline date, the FDA published a Final rule with nine textual warnings accompanied by color graphics.
Shortly after the Final rule was published, a group of tobacco product manufacturers and sellers brought suit alleging that the graphic image warnings and the placement and type-style requirements for the corresponding textual warnings violated their constitutional right to free speech under the First Amendment. The circuit court vacated the graphic warning requirements, holding that the FDA failed to present any data showing that enacting their proposed graphic warnings would accomplish the agency’s stated objective of reducing smoking rates, and remanded to the agency.
FDA progress. After the rule was vacated in 2013, the FDA established a working group to develop the new proposed graphic warnings rule, consulted without outside experts, contracted with a communications and marketing firm, hired a certified medical illustrator, and conducted multiple rounds of qualitative testing. In 2017, the FDA invited public comment on the proposed collection of information regarding proposed revisions to the textual warnings.
According to the FDA, three more years are still needed to complete quantitative studies, analyze the results, draft the proposed Final rule, review the public comments and draft responses to prepare a Final rule. Several national health organizations brought an action seeking a declaration that the FDA "unlawfully withheld" or "unreasonably delayed" promulgating a Final rule and an order compelling the FDA to expedite a Final graphic warnings rule.
Unlawfully withheld or unreasonably delayed. Pursuant to the Administrative Procedure Act, a court shall compel agency action unlawfully withheld or unreasonably delayed. An agency that fails to meet a non-discretionary deadline has "unlawfully withheld" action. In contrast, if an agency has no concrete deadline establishing a date by which it must act, a court must compel only action that is delayed unreasonably. Here, the FDA’s duty to promulgate the rule here was non-discretionary. The court held that even though the Final rule was vacated, the statute and deadlines set forth by Congress continue to apply and the FDA must comply. An order vacating agency action leaves the agency’s duty to act still (or again) unfulfilled because the order merely operated to restore the status quo ante. While vacatur may reset the two-year clock, it did not free the FDA from Congressional mandates and leave the FDA to promulgate the rule at whatever pace it chooses.
Rule of reason. The FDA urged the court to apply the test set forth in another decision that looks to the "rule of reason" in analyzing the time frame agencies take to make decisions and look at the timetable provided by Congress to supply content for this rule of reason. The court noted that Congress initially set a statutory deadline of 24 months, which the FDA initial complied with. After the graphic warning requirement was vacated, the FDA began working on the substance of the textual warnings rather than the graphic images even though the textual warnings were never challenged nor found unconstitutional. The working group did not take action to develop new images until two years after the vacatur.
Despite the two-year schedule initially set by Congress, the FDA asserts that it will take a total of over eight years, or four times the initial amount of time set by Congress. The rule of reason analysis also requires the court to consider the nature and extent of interests prejudiced by delay. The graphic warning rule relates to human health and the end goal of the rule is to decrease the number of people with chronic illness related to smoking and reduce the number of premature death due to tobacco-induced disease. The court found that the interests prejudiced by delay are substantial.
Decision. The court concluded that because the FDA both "unlawfully withheld" and "unreasonably delayed" agency action, the court must compel agency action. The court ordered the FDA to provide an expedited schedule for completion of the outstanding task and issuance of the final rule no later than September 26, 2018. The court intends to direct further action as necessary following the review of the expedited schedule.
The case is No. 1:16-cv-11985-IT.
Attorneys: Jessica A. Wall (Anderson & Kreiger LLP) for American Academy of Pediatrics, Massachusetts Chapter of American Academy of Pediatrics, Inc. and American Cancer Society, Inc. Daniel Kadane Crane-Hirsch, U.S. Justice Department, for the United States Food and Drug Administration.
Companies: American Academy of Pediatrics; Massachusetts Chapter of American Academy of Pediatrics, Inc.; American Cancer Society, Inc.; American Cancer Society Action Network, Inc.; American Heart Association, Inc.; American Lung Association, Inc.; Campaign for Tobacco-Free Kids; Truth Initiative Foundation, D/B/A Truth Initiative
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