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Latest From Michael McCaughan
Upcoming proposed rule will create a process for third parties (notably including the state of Florida) to begin importing drugs wholesale from Canada. It will be an FDA rule – though FDA has had very little input in it.
Centers for Medicare & Medicaid Innovation could enable outcomes-based contracting for novel, 'curative' therapies follow something like the FDA’s Accelerated Approval model, former top HHS official suggests.
US FDA's efforts to enforce against regenerative medicine and other gray market products might be collateral damage in Trump administration's latest attack on the perceived abuse of powers by regulatory agencies.
The debate over price 'negotiation' in the US has taken a turn for the worse for innovator pharma companies. The Democratic party seems eager to plow forward no matter what the impact is on innovation – and some patient advocates are surprisingly eager to cheer them along.
First hearing on the House leadership’s drug price “negotiation” proposal suggests that the real goal of the plan may be to shape negotiations over drug pricing bills – not to create an international price benchmark.
The House Democratic leadership is pushing an international benchmark price for its 'negotiation' plan in the US. The summaries have focused on the maximum price, but the one-sided “negotiation” process suggests that the minimum is the more relevant number – and it is likely to be quite low.