The FDA's decision to grant additional exclusivity to Eagle Pharmaceuticals' cancer treatment Treanda could cost the public $3 billion, according to Regulatory Focus.
Six things to know:
1. Last week the FDA granted Eagle Pharmaceuticals additional exclusivity for Treunda, also known as bendamustine hydrochloride. The decision halts the introduction of generic versions of the injection until December 2022.
2. The decision comes after the company's other bendamustine hydrochloride product, Bendeka, won seven years of orphan drug exclusivity last summer in court. Both Bendeka and Treanda are approved for the treatment of patients with chronic lymphocytic leukemia and patients with B-cell non-Hodgkin's lymphoma.
3. Because of the court decision, the FDA said "the scope of Bendeka's exclusivity extends to all applications containing the same active moiety as Bendeka, bendamustine, and bars the approval of any application containing bendamustine for any exclusivity-protected indication"
4. Before the court ruling and FDA decision, generic versions of Treanda were expected to enter the market in November of this year.
5. Bernstein analyst Ronny Gal, who took issue with the FDA's decision, estimates that "the illogical decision will cost the public some $3 billion in added costs" because generics can't enter the market.
6. "This is poor performance by FDA, which shows that even in the [Dr. Scott] Gottlieb era, the risk-averse bureaucracy can get lost in its own maze of regulations," Mr. Gal told Regulatory Focus.