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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

Alex Azar And The Return Of Republican-Style Price Negotiation

The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but it does not mean that HHS will do nothing about drug prices. On the contrary, it may make some high-profile action against pricing outliers all but inevitable.

Pricing Debate Policy

100% User Fees: A 'Bad Idea' That May Be Inevitable

The Trump Administration isn’t likely to drop the idea of having user fees pay the full cost of reviews. The pharmaceutical industry can afford higher fees, but industry officials worry about the perception if reviews are fully funded.

Drug Review FDA

Public Complete Response Letters? Don’t Hold Your Breath

In interview with the Pink Sheet, US FDA Commissioner Gottlieb indicates agency won’t be making complete response letters public any time soon. Agency will still strive for greater transparency in its regulatory decisions, however.

Complete Response Letters Drug Review

EpiPen 'Failures': More Bad Headlines For Mylan – And Reminder Of FDA's Own Risks

Latest headlines about EpiPen cite deaths associated with product 'failures.' The attention is probably unfair, given the source (US FDA adverse event reports) but it is also inevitable given the history – and may be a warning of headlines to come if and when a generic is approved.

Inflammation Generic Drugs

The Great Rebate Debate: Why Do They Exist?

A Senate hearing on drug pricing and the supply chain inevitably focused on the role of rebates. Committee Chairman Lamar Alexander offered a simple-sounding solution: get rid of them. That’s easier said than done, of course, but it did trigger some interesting discussion from different trade sectors.

Pricing Debate Pricing Strategies

A Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review
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