Eagle Asks Court to Force Bendeka Orphan Exclusivity
Eagle Pharmaceuticals is asking the DC federal court to order FDA to grant seven-year orphan drug exclusivity for its Bendeka (bendamustine HCl), an IV chemotherapy agent. The suit says that the agency granted Bendeka orphan drug designation 7/2/14 and approved it 12/7/15. However, it denied Bendeka exclusivity in a 3/24 letter ruling.
The suit says that FDA took essentially the same position as it did in an earlier case involving Depomed in which it withheld exclusivity and told the company it had to demonstrate that its orphan drug was superior to an existing drug. In that case, Eagle says, a DC federal court judge ruled that the “plain language of the exclusivity provision of the Orphan Drug Act requires FDA to recognize exclusivity for any drug that FDA has designated and granted marketing approval.”
Although the judge invited the agency to change its regulations governing orphan drug designation if it wanted a different result in future cases, Eagle says, FDA instead decided to ignore the ruling. It says the agency placed a notice in the Federal Register explaining its intent to treat the decision as limited to its facts and to “continue to apply its existing regulations.”
Eagle says that the letter it received from the CDER Office of Orphan Drug Development explained FDA’s position that the court had erred in its Depomed decision. And it said that because FDA had concluded that the court decision was inconsistent with its clinical superiority framework and the important policy issues at stake, it has continued to implement its long-standing clinical superiority framework for designation and exclusivity decisions. FDA also argued in its letter ruling that despite granting orphan drug designation, the agency was free to deny exclusivity at the end of the process. Eagle says that despite an agency conclusion when it designated Bendeka as an orphan drug that Bendeka presented a plausible hypothesis of clinical superiority over Cephalon’s Treanda (bendamustine HCl) for injection, FDA reversed course in 2016 and concluded that although Bendeka is safe and effective, the company had not provided sufficient evidence that it is clinically superior to Treanda under the regulatory requirement that the court found unlawful in Depomed.
“There is no doubt that FDA disagrees with the policy behind Congress’ structure of the Orphan Drug Act,” Eagle says. “But FDA is not free to simply disregard the plain language of that statute.”