Worries About Innovation Incentives Keep Some Generic, Patent Bills Out of HELP Legislation
In a win for the branded industry, just one of the three amendments that caused the initial markup of the Senate Health Committee’s drug pricing legislation to be postponed got included in the package advanced to the floor.
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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.
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.
AUTM advocates reform or elimination of inter partes review, DOJ warns of antitrust liability from misrepresentation, and AAM recommends modifying system for measuring productivity of patent examiners.