FDA Petitions U.S. Supreme Court Over Triton MDOs

As previously posted, a federal appeals court (Fifth Circuit Court of Appeals) overturned the Marketing Denial Orders (MDOs) handed down by the U.S. Food and Drug Administration to Triton Distribution and Vapetasia.

This week the FDA filed a petition for writ of certiorari requesting the Supreme Court review the Fifth Circuit opinion and reverse it. The Court “…usually is not under any obligation to hear these cases, and it usually only does so if the case could have national significance, might harmonize conflicting decisions in the federal Circuit courts, and/or could have precedential value. In fact, the Court accepts 100-150 of the more than 7,000 cases that it is asked to review each year” (link to US Courts here).

The Supreme Court has its own set of rules on deciding which cases to hear. According to these rules, four of the nine Justices must vote to accept a case.

The FDA previously opposed petitons for writ from industry. The FDA in its petiton cites two reasons why the Court should hear this case. First, “…Because such a conflict exists now, the Court should grant this petition for a writ of certiorari.” The FDA is referring to, as it does throughout its petition, seven Circuit Courts that have agreed with the FDA’s position. Second, the FDA argues, “…the Fifth Circuit has effectively nullified the Tobacco Control Act’s limits on venue.” The FDA is referring to the TCA’s requirement that an adversely affected person obtain judicial review in the D.C. Circuit, the circuit where it resides, or the circuit where it has its principal place of business. However, the Fifth Circuit “…has held that a manufacturer based outside the circuit may nonetheless seek judicial review within the circuit, so long as its petition for review is joined by a seller of the manufacturer’s products (such as a gas station or con- venience store) located within the circuit.”

The Court is likely to hear the case (although that is far from guaranteed), and its decision could have far-reaching implications for the PMTA review process.

The FDA petition largely attempts to refute the unfair surprise holdings from the Fifth Circuit but does address other points as well, such as the de facto ban referenced in the footnote of the en banc opinion.

If the Court hears the case, expect industry to file amicus briefs in support of the merits.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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