David Rosen Discusses FDA’s Approach to Orphan Drug Exclusivity

Foley & Lardner LLP Partner David Rosen is quoted in the PharmaVoice article, “Why FDA’s approach to orphan drug exclusivity is ripe for more legal challenges,” discussing the confusion over and future of the FDA’s narrow orphan drug exclusivity approach.

Rosen said, “People will be looking at this issue very closely and those people that are adversely affected — either (because) FDA approved somebody when another company was already granted orphan exclusivity, or the FDA denies approval based on this — you’ve got companies on both sides and they’re certainly going to sue FDA over this.”

Rosen explained it’s important for rare disease drug developers to account for the potential uncertainty such lawsuits could bring by ensuring their drug applications cover specific patient populations. He also suggested drug developers try to “tease out FDA’s position” on the indications and extent exclusivity could be granted but warned that such conversations could also turn out fruitless.

“FDA generally won’t talk about anything doing with respect to exclusivity, until the product is ready to be approved or is approved,” he added.