FDA 'Defying' Appeals Court is Troubling: Attorneys
Attorneys James Boiani and Delia Deschaine (Epstein Becker Green) say FDA’s recent Federal Register notice on orphan drug exclusivity (see earlier story) “is a remarkably direct rebuke” of the an 11th Circuit Court of Appeals decision in Catalyst Pharms, “especially in light of Congress’ rejection of legislation that would have overturned Catalyst.” In its notice, FDA said it believes that its approach tying exclusivity to specific indications or populations is appropriate for several reasons. “FDA continues to believe that the statutory text does not unambiguously require that orphan-drug exclusivity extend to the entire disease or condition for which a drug received orphan drug designation if the drug is only approved for some uses within that disease or condition,” the agency said.
The attorneys say the notice raises important questions for drug developers, including how much they should rely on it. They note it simply states an agency policy and can’t overturn the Catalyst decision that is a legally binding precedent, at least in the 11th circuit.
“Beyond orphan drug issues, the FDA’s approach raises questions about the role of the court in FDA matters, as well as the Agency’s general approach to litigation,” they write. “Instead of asking for an en banc rehearing, or appealing to the Supreme Court, FDA decided to expressly reject the court’s interpretation of law, and only recognized the court’s order to affect the very specific case or controversy before it – the one drug product approval at issue.”
Boiani and Deschaine conclude that the agency’s response to Catalyst “may be a signal to the courts that FDA is going to be less deferential to court decisions at a time when many agency decisions have been under attack… The approach in Catalyst may be a harbinger of what FDA will do going forward, trying to protect long-standing FDA regulatory regimes from disruption where Congress will not intervene, but it could trigger a lot of uncertainty, and litigation, in the years ahead.”
Meanwhile, Hyman Phelps & McNamara attorney Sara W. Koblitz writes that FDA defying the Eleventh Circuit’s decision is bold but not unprecedented. A similar “Clarification of Policy” notice followed the Depomed decision (see earlier story). In the same way that FDA “doubled-down” on its pre-Depomed approach, it’s doing the same here,” Kolblitz observes.
She notes that the Depomed notice “led to additional lawsuits from Eagle and United Therapeutics challenging FDA’s demand for proof of clinical superiority, effectively requiring the Agency to relitigate the issue until Congress eventually enacted a legislative fix, and we expect the same will happen here. Obviously, a broader scope of Orphan Drug Exclusivity is a huge boon to an orphan drug sponsor, so it stands to reason that a recipient of Orphan Drug Exclusivity would want to ensure the broadest scope possible and would fight to secure it. FDA likely anticipates such a lawsuit too, and for that reason, is likely to continue lobbying Congress for a legislative fix. But until then, we will sit down with some popcorn and watch the orphan drug lawsuits unfold.”