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On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug exclusivity to a drug over the FDA’s objections, the agency announced it will not deviate from the same interpretation of the Orphan Drug Act that did not win the day in court.

The Orphan Drug Act provides incentives for manufacturers to develop drugs that treat rare diseases. In addition to tax credits and access to certain federal funding, the Act provides an orphan drug’s manufacturer the exclusive right to market the drug for seven years. However, the Act also allows the FDA to approve a subsequent drug if the manufacturer can show that it is “clinically superior” to the first drug.

In 2012, Depomed, Inc., filed suit against the U.S. Department of Health and Human Services (of which the FDA is an agency) seeking orphan drug designation for Gralise, which treats after-shingles pain (also known as postherpetic neuralgia, or PHN). The FDA had already approved a drug in 2002 for the treatment of PHN but it had not been designated by the FDA as an orphan drug. Depomed argued that because no other product had ever been designated as an orphan drug for the treatment of PHN, it did not need to provide evidence of clinical superiority to satisfy that requirement for Gralise’s orphan drug designation application. The FDA eventually granted the request for designation as an orphan drug but stated that Depomed must prove clinical superiority to obtain marketing exclusivity. Depomed then brought its case to court.

Depomed succeeded in its motion for summary judgment before the U.S. District Court for the District of Columbia in September 2014. The court found the plain language of the Orphan Drug Act unambiguously required the FDA to recognize that any drug that has been both designated as an orphan drug for treatment of a qualifying disease and also approved for marketing is entitled to an exclusivity period. The FDA took steps to appeal the decision, but later withdrew its efforts to appeal.

The FDA’s recent policy announcement states that, despite the developments in the<em>Depomed</em> case, the agency will adhere to its original interpretation of the Orphan Drug Act and that the court’s ruling is limited solely to Gralise. The FDA stated that “the sponsor of an orphan-designated drug that is the same as the previously approved drug … is required to demonstrate that its drug is clinically superior to the previously approved drug in order for its drug to be eligible for orphan-drug exclusivity upon approval.”

A copy of the FDA’s notice announcing the policy is available <a href="http://www.gpo.gov/fdsys/pkg/FR-2014-12-23/pdf/2014-29920.pdf" target="_blank" rel="noopener">here</a>. The opinion granting Depomed’s motion for summary judgment in <em>Depomed v. HHS et al</em>., Civil Action No 12-12592 in the U.S. District Court for the District of Columbia, is available <a href="https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2012cv1592-32">here</a>.

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat