FDA opted not to fight a court order requiring it to award Depomed Inc.’s Gralise (gabapentin) seven years of orphan drug market exclusivity. But the agency is not changing its policy on orphan exclusivity: a sponsor will still have to show its product is clinically superior to the same previously approved drug in order to win the designation.

In a Dec. 23 Federal Register notice the agency said the court’s decision in the Gralise case is limited and that it intends to continue to apply its existing regulations on orphan drug exclusivity.

The agency said it will not recognize this exclusivity for a drug when it has previously approved the same drug for the same use or indication in a rare disease or condition. And a drug will not be considered to be the same as a previously approved drug if, at the time of approval, the sponsor has provided evidence that its drug is “clinically superior” to the approved drug, that is, the drug is more effective, safer or makes a major contribution to patient care.

Depomed filed suit against FDA in 2012 when the agency withheld orphan exclusivity for Gralise for management of post-herpetic neuralgia because Depomed did not show that it was clinically superior to Pfizer Inc.’s gabapentin drug Neurontin for the same indication Also see "FDA’s Orphan Exclusivity Requirement For “Clinical Superiority” Challenged In Court" - Pink Sheet, 26 September, 2012..

Depomed argued that Neurontin never received orphan drug designation or orphan exclusivity for this indication and that it therefore should not have to show Gralise’s clinical superiority to Neurontin to obtain orphan drug exclusivity.

Will Other Sponsors Challenge FDA’s Policy?

In September a district court found that Gralise was entitled to orphan exclusivity because it met the two statutory requirements of the Orphan Drug Act: it was designated an orphan drug by FDA and it was approved for marketing. The court suggested that FDA could change the regulations to require applicants to show clinical superiority before granting their product an orphan drug designation ([A#00140915012]).

FDA appealed the district court decision to the U.S. Court of Appeals for the District of Columbia Circuit but subsequently asked the court to dismiss the appeal.

“It is the agency’s position that, given the limited terms of the court’s decision to Gralise, FDA intends to continue to apply its existing regulations … to orphan drug exclusivity matters,” the Federal Register notice states.

FDA interprets the Food, Drug, and Cosmetic Act and its regulations “to require the sponsor of a designated drug that is the ‘same’ as a previously approved drug to demonstrate that its drug is ‘clinically superior’ to that drug upon approval in order for the subsequently approved drug to be eligible for orphan-drug exclusivity,” the notice says.

It is unclear how many companies may be affected by FDA’s narrow interpretation of the court’s Gralise ruling. Hyman, Phelps & McNamara attorneys Kurt Karst and Michelle Butler suggested that another sponsor might again challenge the agency’s position.

“Perhaps this out-of-left-field-strategy is FDA’s way of drawing out another lawsuit from an affected sponsor so that the agency can have another crack to relitigate the issue in court,” they wrote in an FDA Law Blog post.

FDA Grants Gralise Orphan Exclusivity But Rejects Policy Change

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