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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

Revisiting Accelerated Approval: A Provocative Rebate Proposal

Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

Reimbursement Review Pathway

More Like Untouchable? US Medicare ‘Protected Classes’ Stay Protected – Again

A decision made more than 15 years ago by CMS to require drug insurance plans to cover all drugs for six specific diseases has proven impervious to change. But will the protected classes remain if Part D is reformed more broadly?

Medicare Reimbursement

The More Things Change: The Return Of David Kessler To Capitol Hill

A Senate hearing on the US COVID-19 response recalled Kessler’s tenure as FDA commissioner a quarter century ago – and included some reminders that things have changed.

Leadership FDA

Don’t Let The Quiet Fool You: The US Drug Pricing Debate Is At A Critical Point

There won’t be a lot of legislative action in Congress in the weeks following passage of the $1.9tn American Rescue Plan. But the coming months are a critical time for the drug industry to try to set the terms for how it is treated in the next major bill later this year, and the stakes could not be higher.

Pricing Debate Legislation

US FDA And Congressional Oversight: Will Democrats Be Tougher Than The GOP?

Most US agencies can expect relatively friendly oversight from a Democratic Congress. The US FDA might be one exception, as a recent House hearing on foreign inspections shows.

United States FDA

US HHS Nominee Becerra Treading Carefully On ‘March In’ Rights

Past support for so-called ‘march in’ rights is a red flag for biopharma innovators, but after two days of confirmation hearings, industry can be somewhat reassured.

Leadership Politics
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