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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

Medicare Aduhelm Coverage Policy Overrules FDA: Can Two Wrongs Make A Right?

Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?

Medicare Reimbursement

2022: The End Of The US Price Negotiation Debate?

The Democratic party has been advocating for Medicare drug price negotiation authority in the US for almost two decades. The coming year may see it finally happen – or it might mean the issue is gone for good.

Pricing Debate Medicare

US FDA Advisory Committees: Flipping FDAAA Mandate On Its Head

FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?

Advisory Committees Politics

Unasked Questions: The Odd Dynamics Of FDA Commissioner Hearings

Is there anything less satisfying than a confirmation hearing for US FDA commissioner? Robert Califf performed very well during his testimony to return to the post, but no one who follows FDA closely likely learned much they did not already know.

United States FDA

Unasked Questions: The Odd Dynamics Of FDA Commissioner Hearings

Is there anything less satisfying than a confirmation hearing for US FDA commissioner? Robert Califf performed very well during his testimony to return to the post, but no one who follows FDA closely likely learned much they did not already know.

FDA Leadership

The Case For US FDA To Be More Political In Its Approval Decisions

No one thinks it is a good idea for the US FDA Commissioner or some other higher up political actor to decide when and if to approve new drug applications. But it might not be so bad if the scientific staff at FDA paid a bit more attention to ‘political’ issues before making some decisions.

FDA Leadership
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