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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.

Latest From Michael McCaughan

PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates

Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.

User Fees Drug Review

Did The Congressional Budget Office Just Make Price Negotiation Inevitable?

Not only does the CBO’s new model make the impact of draconian changes look small, it also gives a framework for compromise that could make legislation more likely to pass Congress.

Pricing Debate Medicare

Memo To US FDA: ‘Too Fast!’ Plus ‘Too Slow!’ Does Not Mean ‘Just Right!’

There is an old adage that FDA only has two speeds: too fast and too slow. Recent pushback on neurology reviews and Covid vaccines show that paradox – but also the flaw of treating contradictory criticism as a sign that everything is actually fine.

FDA Drug Review

The Rebate Rule: US Pricing Proposal Becomes Congressional Piggy Bank

A policy eliminating rebates in the Medicare Part D program will be delayed until Jan. 1, 2026 – and is very likely to be repealed altogether. If that staves off more draconian reforms, the biopharma industry will celebrate.

Government Payers Medicare

US Medicare ‘Wastage Rebate’ Coming Soon

Manufacturers who sell single-use vials for products covered by Part B have about 16 months to consider pricing or packaging changes that may minimize exposure to a new refund for ‘wasted’ drug.

Medicare Politics

Ellis Unger’s US FDA Farewell Address?

The US FDA advisory committee review of AstraZeneca/FibroGen’s roxadustat for anemia was the last in the long tenure of Office of Cardiology Director Ellis Unger. His opening remarks struck a valedictory tone.

FDA Leadership
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