Orphan Drug Exclusivity: In Narrow Application Of Catalyst Ruling, FDA Retains Its Existing Regs
US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.
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Senate Committee Passes Moderate PBM Reform, But Has Its Eyes On Stronger Policies
Delinking pharmacy benefits managers’ compensation from the prices of drugs received bipartisan rhetorical support at a HELP markup, but the panel only cleared less drastic PBM reforms along with generic and orphan-drug focused policies. Approved amendments tackled step therapy, pharma transparency and PBM gag clauses, among other topics.
Senate HELP Panel’s Confounded Markup Points To Challenges Ahead For Chairman Sanders
Session on PBM and generic legislation brought to a halt by Republican objections to amendments targeting FDA disclosure of inactive ingredient concentrations in brands, method-of-use patents, and using REMS to extend patent protection.
Senate HELP Panel PBM Bill Requires Rebate Pass-Through, But Not To Plan Members
Bipartisan legislation announced by Sens. Sanders and Cassidy also emphasizes pharmacy benefit manager transparency and bans spread pricing.