FDA warns of ‘grave’ knock-on effects from Eagle decision
The US Food and Drug Administration (FDA) has warned a US Court of Appeals for the DC Circuit decision awarding market exclusivity to Eagle Pharmaceuticals for a cancer drug will have “grave” consequences for patient access.
The DC court ruled in March that Eagle was entitled to exclusivity for Bendeka (bendamustine), which treats a rare blood cancer, under the Orphan Drugs Act (ODA).
Introduced in 1983, the ODA provides extra incentives, including seven-year exclusivity, for drugmakers to develop treatments for rare diseases.
The FDA can designate pharmaceuticals as orphan drugs if they are for treating diseases that affect fewer than 200,000 people.
In 2015, the FDA approved orphan drug Bendeka for marketing but refused to award Eagle the seven-year exclusivity on the grounds that Bendeka was not clinically superior to a previously-approved version of the same medicine sold by a different company.
In effect, the FDA refused to grant exclusivity to multiple companies selling similar products.
Eagle appealed to the US District Court for the District of Columbia, arguing that it should have been automatically awarded all of the protections that come with orphan drug status under the plain language of the ODA.
The DC court granted summary judgment in favour of Eagle, finding that Congress’ intent was “clearly expressed” in the ODA as automatically awarding exclusivity for orphan drugs.
An FDA appeal to the DC Circuit was struck down in March by a vote of 2-1. The FDA now wants the entire panel of DC Circuit judges to review that decision, arguing that it “defies common sense”.
In a petition filed Wednesday, May 27, the FDA argued the interpretation of the ODA adopted by the majority in the DC Circuit was “gravely mistaken”, and would force it to: “provide successive, seven-year exclusivity periods for an unlimited series of functionally identical, follow-on versions of a pioneer orphan drug, thereby potentially restricting market entry for competing products and artificially raising the drug’s price for decades.”
In effect, the FDA said, the DC Circuit’s reading turned what Congress intended to be an exclusive monopoly into a series of non-exclusive protections shared by multiple companies.
The ODA was amended in 2017 to “expressly codify” the FDA’s single-exclusivity reading, the agency told the court. But as the Bendeka case stems from before the amendments, the DC Circuit’s decision is based on the older version of the legislation.
The FDA also warned of knock-on effects, with new exclusivity protections applying retroactively to drugs approved before the 2017 amendments.
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