The health care reform law dramatically expanded the number of entities eligible to purchase drugs via the federally administered 340B program, while simultaneously increasing the size of the mandatory discounts given to covered entities. Manufacturers are understandably frustrated. Rather than hope for elimination of the program, however, they may be better served working within the system to contain its impact.
By Michael McCaughan
The US pharma market is often described as unique in the industrial world, because it lacks price controls.
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A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.
States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.
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The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.
Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
