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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

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

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
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