FDA draws line in sand over its orphan drug policies

The FDA says it will abide by a court ruling stating it has to grant orphan drug exclusivity to Depomed's ($DEPO) Gralise, even though it has vigorously fought doing so on the belief that it was essentially the same as one already approved, Pfizer's ($PFE) Neurontin, and so it is not entitled to the added benefits. But the agency has drawn a line in the sand, saying it does not intend to extend the same benefit to any other drugmakers under the same circumstances.

To allay "any uncertainty created by the court's decision," the FDA late last month filed in the Federal Register a "clarification" to the policy on orphan-drug exclusivity. It said it intends to continue to follow its previous interpretation of the law. "It is the Agency's position that, given the limited terms of the court's decision to Gralise, FDA intends to continue to apply its existing regulations," the clarification reads.

As the FDA Law Blog points out, that is even though the court's ruling in September granting Depomed summary judgment against the FDA said, "the plain language of the exclusivity provisions of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that the FDA has designated and granting marketing approval."

Depomed sued the FDA in 2012 after it denied it exclusivity for Gralise, even though the agency has already granted its orphan drug status for treating postherpetic neuralgia (PHN), a complication from shingles. The FDA said its policy was that if a drug was essentially the same as one already granted exclusivity, it must at least be "clinically superior" to also get exclusivity.

It said Gralise is the same drug as Neurontin, "because it contains the same active moiety (gabapentin), was approved for the same use (post-herpetic neuralgia), and was not demonstrated to be clinically superior to Neurontin." Gabapentin itself is an off-patent drug made by a number of generic makers. It was initially approved by the FDA in 1994 as a seizure treatment, and won FDA approval for shingles pain in 2002. But the court said it didn't matter, Depomed was entitled to exclusivity for Gralise.

So why did the FDA go public with its position? Steve Grossman, president of consultants HPS Group, tells in-PharmaTechnologist.com that the FDA may be "inviting a legal appeal" in hopes of reestablishing in court the rules it intends to play by. Or, he said, it may just figure that it is unlikely the same set of circumstances will arise again, at least with a drug maker that is willing to lay out money for a legal fight.

- here's the clarification
- read the FDA Law Blog here and here
- get more from in-Pharma Technologist.com

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