Federal legislators failed to act on the rising tide of anti-PBM sentiment in 2024, but health policy experts predict that the risk of regulatory intervention will ramp up this year even with Republicans, who traditionally are viewed as business friendly, controlling Congress and the White House.
This Year, PBM-Directed Fury May Once Again Signify Nothing
Anti-PBM sentiment continues to rise, but industry observers still question whether the reforms being discussed will be effective.
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An analysis of Medicare Part D and other data found that more than one-third of all pharmacy spending went through pharmacies owned by Cigna, CVS Health, Humana or UnitedHealth Group.
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The leader of the House Energy and Commerce Health Subcommittee has a plan for passing pharmacy benefit manager reforms, but Democrats are skeptical.
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The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
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Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.
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The inspector general said the council should be more involved in specific approval decisions when there is internal disagreement, but FDA said that would preclude some individuals from adjudicating a subsequent withdrawal proceeding.
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Two recent accelerated approval guidances describe the FDA’s policy expectations for trial timeliness, but recognize the need for case-specific determinations. Regulatory actions in 2024 show the FDA is willing to delay application filing or approval over confirmatory trial status.
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While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.