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Michael McCaughan

Michael McCaughan has has 25 years of experience providing analysis and insight about the biopharma industry, including 10 years as Editor-In-Chief of The Pink Sheet and The Pink Sheet DAILY. He speaks frequently on regulatory and policy developments affecting the industry.
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Latest From Michael McCaughan

The FDA Commissioner Shuffle And Canadian Rx Imports

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.

Pricing Debate Policy

Accelerated Approval For Medicare Coverage? FDA Model Could Be Useful For Value-Based Agreements

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.

Reimbursement Government Payers

White House Advances War On 'Guidance'; FDA Not Target, But May Feel Ripple Effects

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.

Guidance Documents Regulation

Biopharma’s Innovation Defense Is Crumbling

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.

Pricing Debate Medicare

The Real 'Negotiation' In HR3: Framing The Pricing Debate

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.

Pricing Debate Legislation

House Price 'Negotiation' Plan: It Is Even Worse Than It Sounds

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.

Pricing Debate Reimbursement
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