Depomed Decision Won’t Force FDA to Change Orphan Drug Program

The FDA will maintain its policy on determining when an orphan drug product is entitled to market exclusivity, saying a recent federal court ruling that overruled the agency’s policy applied to just one drug and established no precedent.

Drugmakers seeking orphan status for a rare disease therapy that is the same as a previously approved drug must still prove their product is clinically superior, the agency said.

The three-page policy restatement stemmed from a court ruling that forced the agency to grant seven years of market exclusivity to Depomed’s post-shingles pain drug Gralise (gabapentin) in a case involving whether the drug was clinically superior to Pfizer’s Neurontin (gabapentin).

The FDA had granted Gralise orphan drug status in 2010, but withheld marketing exclusivity when it launched in January 2011, claiming that Depomed presented no definitive proof that Gralise was better than Neurontin in treating post-herpetic neuralgia.

Depomed argued in a 2012 lawsuit that a drugmaker must prove clinical superiority only when the other product with the same active ingredient also is an orphan drug, a status Neurontin never obtained. The U.S. District Court for the District of Columbia in September sided with Depomed and the FDA granted the exclusivity a month later.

The FDA dropped its appeal to the case last month.

One legal expert said he had anticipated the FDA would to change its policies to reflect the court’s decision. The agency may be seeking a way to draw out another lawsuit to relitigate the issue in court, said Kurt Karst, an attorney with Hyman, Phelps & McNamara, of the decision to maintain the status quo.

To read the Federal Register notice, visit www.fdanews.com/12-22-14-OrphanDrugDecision.pdf. — Robert King