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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

Part D Out-Of-Pocket Cap Would Be $2,000 In House Drug Pricing Bill

It may seem perverse to look for silver linings for the drug industry in the House leaderships “price negotiation” bill. But if you can get past Title 1, the bill reads like an attempt to negotiate with the Senate Finance Committee – and it’s not all bad.

House Democrats Launch Price Negotiation Push: Extreme Plan Assures Strong Opposition

Pelosi is moving forward with a draconian plan to limit US prices to an international benchmark. For now, the “bill” is a three-page outline subject to considerable legislative drafting – and so extreme as to rule out bipartisan compromise for the time being.

Pricing Debate Legislation

The New Payer Dogma: US FDA Approved Drugs Have 'Less Evidence'

It is now a common assertion among insurers that one of the many challenges they face in covering high-priced specialty therapies is that drugs are approved with “less evidence” than used to be the case. That is more myth than reality – but a very dangerous myth if it isn’t corrected by the US FDA and the drug industry.

Drug Approval Standards Pricing Debate

House Democrats And Price Negotiation: Slogan Is Unifying, But Policy Is Tougher

The most important thing to know about a draft version of the House Democratic leadership’s proposed drug price negotiation plan is that it is still just a draft – not the draft – much less a bill that could pass the Democratic controlled House, to say nothing of the GOP controlled Senate.

Pricing Debate Legislation

US FDA Commissioner Search: Did Sharpless’ Hopes Just Go Up In Smoke?

US FDA Acting Commissioner Sharpless’ time in office may be rapidly running out. The Trump Administration appears ready to pick an outside candidate to run FDA, with MD Anderson’s Hahn now the apparent front-runner. A prominent Democratic Senator’s criticism of Sharpless and his response to vaping may be the final blow.

FDA Leadership

US FDA Commissioner Transition: Sharpless Audition Is Ending – Will He Get The Part?

Ned Sharpless has been acting head of the US FDA for five months but has not yet been formally nominated for the permanent post. The emergence of another new name as a possible candidate underscores how uncertain the transition still is.

FDA Leadership
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