Drugs

Act on Orphan Drug Exclusivity: Attorney

Attorney George O’Brien (Mayer Brown) says FDA should take a more nuanced approach to orphan drug exclusivity (ODE), which has been in limbo since the 9/2021 11th Circuit Court of Appeals decision in Catalyst Pharms v. Becerra that struck down the agency’s indication-specific interpretation of ODE. In an online post, O’Brien writes that since the decision, the CDER Office of Orphan Products Development (OOPD) has deferred all pending orphan exclusivity determinations.

“Rather than recognize a broad, disease-specific scope of orphan exclusivity consistent with the 11th Circuit’s opinion,” O’Brien writes, “the agency appears to be waiting for a legislative fix to effectively overrule the Catalyst decision. The status of that legislative fix is in jeopardy, however, in light of the recent passage of a ‘clean’ version of the FDA user fee reauthorization provisions without any changes to the Orphan Drug Act. As a result, sponsors remain in the dark about the impact of the court decision, and FDA has given little indication how the agency intends to proceed.”

O’Brien suggests that for products approved since the Catalyst decision was finalized, OOPD should make a final determination about whether the product has earned ODE and make that determination public by noting the exclusivity in the Orange Book. He says taking that action would give sponsors greater clarity, without forcing FDA to address the scope of the ODE unless and until necessary, or the legislative fix arrives. He also says FDA could consider opening a public docket to solicit stakeholder feedback on proposed resolutions should a legislative fix not arrive soon.

For sponsors of recently approved orphan products who are unlikely to face competitor applications in the short term, O’Brien writes, further patience will likely be required as the agency waits to see whether the legislative fix will arrive.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome